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Healthcare - Biotechnology - NASDAQ - US
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2016 - Q1
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Operator

Good day, ladies and gentlemen, and welcome to the First Quarter Catabasis Pharmaceuticals Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

[Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today’s conference Ms. Andrea Matthews, Executive Director of Corporate Affairs. Ma’am you may begin..

Andrea Matthews Chief Business Officer

Thank you, Shenell [ph]. Welcome to today's conference call to provide a corporate update for Catabasis Pharmaceuticals and to review our first quarter 2016 financial results. With me today from Catabasis' management are Jill Milne, Chief Executive Officer; Joanne Donovan, Chief Medical Officer; and Rick Modi, Chief Business Officer.

We issued a press release after the market close today summarizing our corporate update and our Q1 2016 financial results, which we will reference on today's call. This press release is available on our web site.

I would like to note that during today's call, we will make statements related to our business based on current and future expectations that may be considered forward-looking statements under federal securities laws.

Actual results may differ materially from those indicated by these statements as a result of a variety of risks and uncertainties, including those that were discussed in our most recent quarterly report on Form 10-Q, which we filed this afternoon with the SEC and is also available on our website.

Such statements represent our judgment as of today, and Catabasis undertakes no obligation to publicly update any forward-looking statements except as required by law. With that, let me pass the call over to Jill Milne, Chief Executive Officer, who will provide the corporate and financial update.

This will be followed by Joanne Donovan, our Chief Medical Officer, who will review our progress with our clinical program.

Jill?.

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Thank you, Andrea. Good afternoon everyone and thank you for joining us today for our corporate and financial update for the first quarter of 2016. We believe that Catabasis is in a position today. Since our IPO last year we have significantly improved our fundamentals and achieved all of our anticipated development milestones.

We executed on the plan we had laid out, successfully advanced our pipeline and we now have two programs in Phase 2 trials. Importantly, we are now entering a period of upcoming catalyst events, including the readouts from each of our Phase 2 programs expected in the reminder of the year.

We’re looking forward to these readouts as they represent two non-core related short time goals and while our confidence in these programs has always been high it has increased since our last call, thanks to new data.

We believe both our Phase 2 programs CAT-1004 and CAT-2054 have the potential to be transformative in the treatment of the diseases they targeted and each offers a strong value proposition in its own right. Let me highlight the data supporting our enthusiasm. I’ll start with CAT-2054 as that is the next expect readout.

We are developing CAT-2054 as a potential new category of therapy, one that maybe effective for NASH and hypercholesterolemia, two very large markets. We engineered CAT-2054 to target SREBP, a master regulator of lipid metabolism.

We have been aware for quite some time that SREBP targets proteins that play an important role in the pathway genesis of NASH and therefore, we have been pursuing NASH both internally with external collaborators.

Our studies have now born out that by inhibiting SREBP, CAT-2054 may demonstrate significant effects not only on LDL-cholesterol, but also on liver inflammation, fibrosis and steatosis.

We have seen promising preclinical results in multiple NASH models using an analog of CAT-2054, including positive effects on liver inflammation, fibrosis and steatosis. Notably, we saw return to baseline for ballooning degeneration and a reduction in pre-neoplastic lesions, two negative consequences of NASH.

We plan to present these results at an upcoming scientific conference later this quarter. Recall that we completed a Phase 1 trial of CAT-2054 and absorbed no safety signals and we have seen good tolerability and reductions in LDL-cholesterol. We also did not see any affects on the PK of atorvastatin.

We believe these results bode well for the four week Phase 2a trial of CAT-2054 we are now conducting and patients with hypercholesterolemia in addition to higher intensity statin.

I am pleased to say enrolment for this trial is complete, ahead of schedule and we now expect to release top line results around midyear ahead of our previously announced expectation of Q3. We look at the Phase 2a trial as a dose finding and proof-of-concept study for SREBP in addition that may guide future studies in NASH and hypercholesterolemia.

Given the positive preclinical results we have seen a NASH, we would view seeing no safety signals good tolerability and statistically significant reductions in LDL-cholesterol during the four weeks of therapy as a success. We also believe that LDL-cholesterol reductions would be proof-of-concept supporting clinical SREBP in addition.

Our strategy is to out-license CAT-2054 prior to Phase 3 with acceptable terms, if this strategy is successful it might offer an attractive path to monetizing this asset. Let me now move to our lead program, CAT -1004. We expect to report top line data for CAT-1004 from the Phase 2 portion of the MoveDMD trial in late 2016.

I’m happy to say we have an INN name for CAT-1004 either saw an extend, we are seeking to develop Edasa as a new standard of care for Duchene Muscular Dystrophy and believe that it has the potential to be effective in all patients with Duchene regardless of new patient type.

Edasalonexent has the potential to be disease modifying, meaning it could slow the relentless degeneration of muscle, while enhancing muscle regeneration. We’re pursuing this vision by a well thought-out development plan that we believe is consistent with regulatory guidance using randomized double-blind placebo-controlled trials.

As a reminder, Edasalonexent is an oral small molecule that inhibits enough NK-KB, approaching that is activated in the very early stages of DMD and is instrumental in the progressive muscle degeneration in DMD. This inhibition of NK-KB is also important to number of other rare diseases.

We are currently conducting the MoveDMD trial in DMD boys ages four to seven, who are at a fairly early stage of their diseases and so are relatively homogeneous in terms of their state of disease progression.

We presented positive safety, tolerability and pharmacokinetic data from Part A of the MoveDMD trial at 2016 muscular dystrophy association clinical conference in March and have also recently announced positive NK-KB bio market data from Part A demonstrating significant target engagement in a dose-dependent manner in boys affected by Duchene.

Note that we have now shown safety, tolerability and target engagement for Edasa, Edasalonexent in three different clinical trials, two in healthy adult and one in boys with DMD. We have found our interactions with the FDA to be collaborative and constructive.

We have initiated Part B the Phase 2 efficacy portion of the MoveDMD trial, assuming patient enrolment proceeds as anticipated, we expect to release top line results from our MoveDMD trial late this year.

Catabasis appreciates receiving grant funding from the muscular dystrophy association to support Part B of MoveDMD trial, which is in addition to the parent project muscular dystrophy funding support we received for Part A.

In addition to our clinical stage product candidates, we have a robust preclinical pipeline, the most advanced program is CAT-4001 a dual NF-kB inhibitor and our F2 activator, which we are evaluating for ALS and Freidreich ataxia.

In January, we announced a grant from the Freidreich ataxia research alliance to help fund our exploratory and preclinical work. We are conducting further preclinical studies for CAT-4001 in both ALS and Freidreich ataxia and plan to conduct IND enabling activities.

Assuming success with these activities, our goal is to advance CAT-4001 into the clinic next year. We continue to apply our SMART linker technology to discover and develop additional rare diseases. We’re targeting multiple biological pathways may yield important enhancement in efficacy.

Our current efforts here focus on rare diseases including ALS, Friedreich’s ataxia and cystic fibrosis. A paper on our SMART linker drug discovery platform was featured in the February issue of the journal of medicinal chemistry, detailing our proprietary technology that generates our pipeline of development candidates.

We’re also very pleased to have two highly qualified industry expects join the Catabasis Board of Directors last month. Dr. Burt Adelman and Michael Kishbauchl, both brings deep strategic and operational experience in performing senior leadership roles and large cap pharmaceutical, as well as development stage biotechnology companies.

Burt brings extensive drug development and commercialization experience and Michael has more than 20 years of executive leadership and company building experience in the pharmaceutical industry. We also announced the formation of the science and technology committee of the board shared by Dr.

Adelman to advance our innovative approaches to treat diseases with high unmet needs. Burt and Michael will be an integral part of the team and we look forward to their contributions and guidance. For our first quarter of 2016 financial update, our press release this afternoon provides details. So I’ll just provide a brief summary here.

As of March 31, $52.6 million of cash, cash equivalents in marketable securities, which we expect to provide us runway through Q2 of 2017. Importantly, we expected our current cash balance will provide funding well beyond both Edasalonexent MoveDMD Part B readout and the CAT-2054 Phase 2a readout.

In the first quarter of 2016, our net cash used in operating activities was $9.1 million. Our R&D expense was $6.4 million in Q1, an increase of $1.8 million over our R&D expense in Q1 of 2015. The increase was primarily due to increased direct program cost related to the Edasa MoveDMD trial and the CAT-2054 Phase 2a trial.

Our G&A expense was $2.8 million in Q1, an increase of $1.1 million over our G&A expense in Q1 of 2015. This increase was primarily due to increased employee compensation cost and increased consulting and professional expenses to support our more advanced R&D pipeline and overall growth.

Our operating loss was $9.2 million in Q1, an increase of $2.8 million versus Q1 of 2015. Our net loss of $9.4 million or $0.61 per share in Q1 was an increase of $2.9 million over our net loss in Q1 of 2015. For the first quarter, we had weighted average common shares outstanding of $15.3 million.

Additional financial information is available in our 10-Q, which we filed with the SEC earlier today. I’ll now ask Joanne Donovan, our CMO to provide a more detailed update on our clinical programs..

Joanne Donovan

Thank you, Jill and good afternoon everyone. I’ll start with the CAT-2054 program as that is expected to readout next around midyear. We are developing CAT-2054 for the potential treatment of NASH and hypercholesterolemia.

We’ve completed a number of studies to further characterize the molecular mechanism of the CAT-2000 series molecules to our collaboration with the UT Southwestern Medical Center. You may remember this center has done pioneering work in cholesterol metabolism and they are experts in the SREBP pathway.

We’ve also completed our own preclinical studies in multiple models of NASH, using CAT-2003 and analog of CAT-2054. CAT-2054 of course is our active program in the clinic. We believe the findings have been consistent and compelling, showing inhibition of both ISO forms of SREBP.

SREBP 1 and SREBP 2 with impact on downstream genes and metabolic parameters supporting the potential of CAT-2054 in both NASH and hypercholesterolemia. In preclinical models of NASH, we’ve also demonstrated robust reductions by CAT-2003 in liver inflammation, fibrosis, and steatosis.

Importantly, we saw a reduction of ballooning degeneration to baseline levels and we also saw reductions in pre-neoplastic lesions. We intent to present these results at a scientific conference later this quarter. Our takeaways are that CAT-2054 may have therapeutic utility in NASH, as well as positive effects on estrogenic lipids.

NASH and hypercholesterolemia are in fact interrelated indications as NASH has been shown to be a cardiovascular risk. Recall that we have demonstrated safety, tolerability and LDL effects with CAT-2054 in the Phase 1 trial as well as no evidence of impact on atorvastatin PK.

We are currently conducting a four-week Phase 2a randomized double-blind placebo-controlled trial of CAT-2054 in addition to high intensity statin in patients with hypercholesterolemia. I’m pleased to say that we’ve completed enrollment ahead of schedule and now expect to report top line results around midyear.

As planned, the Phase 2a trial enrolled approximately 150 patients with hypercholesterolemia on statin.

After a leading period with four weeks of high intensity statin, atorvastatin 40 milligrams, patients were randomized to doses of 250 milligrams a day, 400 milligrams a day, 250 milligrams twice a day, 400 milligrams twice a day of CAT-2054 or placebo in addition to atorvastatin.

The primary end point efficacy for this trial is present reduction in LDL cholesterol from baseline. We’re also exploring the activity of CAT-2054 and other parameters, including trends in liver function test.

We’ve look at this trial as a dose finding and proof-of-concept study for SREBP inhibition that may guide future studies in NASH and hypercholesterolemia.

Given the positive preclinical results, we’ve seen a NASH, we view seeing no safety signals, good tolerability and statistically significant reductions in LDL-C versus placebo during the four weeks of therapy as success for the currently running Phase 2a trial. Seeing favorable trends in liver function test would be a bonus.

Now, I’m going to move to our lead program CAT-1004, also known as Edasalonexent or Edasa. The MoveDMD trial with Edasalonexent is being conducted in two sequential parts, Part A and Part B.

In Part A, is 17 ambulatory boys between ages four and seven with a genetically confirmed diagnosis of DMD received Edasalonexent for seven days at doses of 33, 67 or 100 milligrams per kilogram per day. The boys with steroid naive or had not used steroids for at least six month prior to the trial.

We presented the results of Part A at the 2016 MDA clinical conference. We’re very pleased with the result. All three doses of Edasalonexent tested were generally well tolerated with no safety signals observed. The majority of adverse events from were mild in nature, the most common adverse events for gastrointestinal primarily diarrhea.

There were no serious adverse events and no drug discontinuation. Furthermore, doses of 67 and 100 milligrams per kilogram per day achieved exposures at which NF-KB inhibition was observed in adults. We’ve also recently announced positive biomarker results from Part A of the MoveDMD trial, demonstrating successful NF-KB target engagement.

After seven days of dosing the biomarker assay piloted in boys effected by Duchenne showed a statistically significant decrease in NK-KB targeted gene expression compared to base line at the 67 and 100 milligram per kilogram per day doses, consistent what we’ve in adults.

This is particularly encouraging when we consider that preclinical bio distribution studies have shown that Edasalonexent concentrations in muscle are 5 to 10 times higher than in plasma. Based on these results, we advanced daily doses of 67or milligrams per kilogram per day into Part B, the Phase 2 part of the trial.

Now that we have shown safety, tolerability and target engagement for Edasalonexent in three different clinical trials, two in healthy adults and one in boys with DMD. We plan to submit the Part A biomarker data for presentation at an upcoming scientific meeting.

We’ve had what view as collaborative and constructive interactions with the FDA and initiated the Part B Phase 2 efficacy portion of the MoveDMD trial. A randomized double-blind placebo-control trial to evaluate the safety and efficacy of Edasalonexent in DMD over a 12-week period.

We’re enrolling 30 boys age four to seven effect by Duchenne in Part B. All of the boys that were originally randomized to placebo for 12 weeks will then receive Edasalonexent for a subsequent period of 12-weeks, so that all boys that will be enrolled in this study are expected to receive Edasalonexent treatment.

The 17 boys that participated in Part A are being after participate in Part B and additional patients are also being enrolled, entry criteria are similar to those in Part A. The primary end point for Part B of the trial is MRI with age appropriate, time functional test as secondary end point.

These include the 10-meter walk run, time to stand, and forced air climb. Note that we’re not including the six minute walk test as that test isn’t appropriate for boys of this age due to the attention or requirements. We’re also measuring the North Star ambulatory assessment, the PODCI and muscle strength.

If the safety profile of Edasalonexent continues to be acceptable, in 2016, we anticipate continuing into an open labeled extension study following MoveDMD Part B. We look at corticosteroids as providing proof of biology as they have shown positive results on MR in 12 weeks in small sample sizes.

Assuming positive data from the MoveDMD trial, we plan to work towards the study, a non ambulatory boys with DMD in 2017. Assuming positive move DMD trial data and after regulatory discussions, we expect a design and conduct a placebo-controlled pivotal Phase 3 study in 2017.

We expect that this study will be six months in duration with one of the age appropriate time functional test as the primary end point. This study would be informed by the results from our current study.

We want to say also that we are very appreciative of the strong interest in the MoveDMD trial and want to thank participating families, advocacy groups, investigators, study staff and experts for their support and participation.

Importantly, our approach to developing a therapy for DMD is highly differentiated from the programs in late stage development in the indication. Edasalonexent has the potential to be effective in all patients with Duchenne, regardless of the mutation type.

We anticipate that Edasalonexent would be disease modifying meeting slowing the relentless muscle degeneration seen in Duchenne and also enhancing muscle regeneration. In our current development plans for Edasalonexent, we do not need to do muscle biopsies with the inherent variability that they bring.

We are not using the six minute walk test and we plan to perform a pivotal placebo-controlled trial. Our plans follow a well thought-out development path to approval with adequately sized randomized double-blind controlled trials and safety database.

We believe this path is consistent with regulatory guidance and aligns well with our learnings from the recent briefing books and advisory committee discussions. More importantly, we’re leveraging an intent to continue to leverage our fasttrack status to work closely and collaboratively with the agency.

Whereas we are developing and are confident the potential of Edasalonexent as monotherapy for the treatment of Duchenne, we believe that a combination drug approach could offer additional benefits.

We’re continuing to follow the literature suggesting that NF-KB in addition strategy combined with the dystrophin targeted approach makes further enhanced dystrophin production and we intend to explore this combination approach over time.

In summary, we are very pleased with our execution and results so far with our two Phase 2 programs and our confidence continues to increase for each of them. This concludes our prepared remarks and we’ll be now happy to take your questions.

Operator, can you please repeat the instructions and poll for questions?.

Operator

[Operator Instructions] And our first question comes from the line of Christopher Marai of Oppenheimer. Your line is now open, please go ahead..

Christopher Marai

Hi, good afternoon guys, congrats on the progress and we look forward to your data. Perhaps I’ll take this opportunity to put Joanne on a hot seat for a few minutes here. With respect Joanne to CAT-2054, what type of percentage change in LDL-C from baseline? Are you looking for to trigger a successful trial reload? If you could maybe remind us.

And then, in terms of the favorable trends in liver function, again what would you perhaps be looking to see there numerically? Thanks..

Joanne Donovan

Okay. So what we are hoping to see is a statistically significant reduction in LDL. This is a four week proof-of-concept study and we’re also looking at safety and tolerability. So that’s where we are considering success in the study.

We are looking at the trend in LFTs, we know that these move relatively slowly over time, but we are looking to see a standard ALT, AST and other liver function tests over time and we would consider that actually a bonus..

Christopher Marai

Okay.

And then, just in terms of the percentage that you would deem successful?.

Joanne Donovan

So we are considering statistically significant affect as a success in this study..

Christopher Marai

Okay. And then, with respect to CAT-1004, it has a nice name by the way.

Maybe share your thoughts regarding the benefit that might be delivered to patients versus asteroids and I think steroids also work by inhibiting some of the NF-KB signaling, but perhaps other mechanisms and what have you done in terms of, maybe teasing out the particular biological or cell signaling effect given your SMART linker technology, as targets those specific signaling pathways? Thanks..

Joanne Donovan

Thanks, Chris. So we think that the NF-KB pathway has important advantages. It has basically, it is targeting not only information, but it is also allowing muscle regeneration and that’s very different from steroids. And so we think that over the long-term this can be provide important benefits beyond potentially what steroid shall.

I mean for the short - in the three months study what we are looking at is evidence as our primary end point, we’re looking at evidence of decrease and information changes in muscle on MR T2..

Christopher Marai

Okay.

And then, so would you expect that over time the T2 MR measures of information would reduce? And that it wouldn’t necessarily be a bad thing if the reductions where less than what you might initially see with steroids, would that be a correct assumption just as sort of frame again expectations for the data set and try to understand what we’re looking at relative to like you noted the data from the T2 MR signals that’s in the published literature?.

Joanne Donovan

I think what we are considering a success for this trial is a reduction in T2 over three months. We’ve seen that is possible in terms of having an effect very rapidly. T2 is a parameter that changes quickly. We’ll also be looking over the longer term though.

And as we advance into a open label extension, we’ll also be able to look at not only T2, but over the longer term of liver fat changes as well..

Christopher Marai

Great and just only one last question on the T2 signals, do those bounce around a lot or do they tend to be pretty consistent and trend in one direction in patients. Especially, over the time course your measuring or I guess what’s the variability in that measurement? Thank you..

Joanne Donovan

The T2 increases inexorably over time in these patients when you look over average and even in a small number of patients in a literature they were able to see statistically significant changes versus corticosteroid naïve patients.

So, we think that this is - we’re able to power this based on a study that we are very closely following the pattern of in a literature, which we think that de-risks the approach and allows us to power it appropriately..

Christopher Marai

Great. Thanks for the all the questions. I’ll jump back in the queue..

Operator

Thank you. And our next question comes from the line of Joel Beatty of Citi Group. Your line is now open, please go ahead..

Joel Beatty

Hi, and thanks for taking the questions.

First question is the recent outcome on DMD, I am just curious if you had any takeaways from the meeting that might affect the outlook and potential for applying base data from the current trials for the drug formerly known as CAT-1004?.

Joanne Donovan

Yeah. Sure thanks Joel, this is Joanne. Certainly, we’ve been following very closely the recent Advisory Committee Meetings and I think what’s clear to us is the FDA clearly recognizes DMD as profound unmet medical need and is working with companies like ourselves and the others to try to get some new medicines approved in this area.

For us, I think there were a couple of takeaways for us. One is I think it certainly gave us confidence and reinforced our plans, our development plans for Edasa and what we’re doing in our MoveDMD trial and gave us confidence in that we’re on the right path there.

And I think we certainly have benefitted with our program in that we’ve been able to design our MoveDMD Phase 2 trial post the release of the 2015 FDA guidelines, which certainly puts us in a good position.

In addition to that as you know for Edasa, we have fast track status and of course we take full advantage getting in front of the FDA and interacting with them as much as possible along and each major step in our program.

And I think that fast track status combined with having the regulatory guidance already out there such as up well for planning our pivotal Phase 3, which if the MoveDMD trial is successful later this year we intend to initiate in 2017..

Joel Beatty

Okay, good.

And then, the question on CAT-2004, when you talked about potential partnering placebo data, did you have an idea of how you would like the partnership to look like if there is any particular aspects of the drug that you’re looking to retain?.

Joanne Donovan

Yeah, sure. I’m going to hand it over to Rick Modi, our Chief Business Officer to address that because he is obviously directly involved in those discussions..

Rick Modi

Hi, Joel it’s Rick. Thanks for the question. So, we’ve been having partnering discussions since we actually had the Phase 1 data in hand.

There has been interest from some of the big players that are out there and since the NASH data has been and will enhance us well we will continue those discussions both with those partners that were interested post Phase 1 and some additional ones that have interested NASH as well.

And our vision for this type of a deal would be to essentially do a global out licensure for the CAT-2000 series.

Does that answer your question?.

Joel Beatty

Yes. Thank you.

Operator

Thank you. And our next question comes from the line of [indiscernible] of Wedbush Securities. Your line is now open please go ahead..

Unidentified Analyst

Yes. Hi, thank you for taking my question. For CAT-1004, I was wondering if you can provide any additional color on enrollment. I guess for instance to date how many boys from Part A have grown over to Part B? And for 2054, how could we follow results from the Phase 2 trial? Can you initiate a study in NASH if at all? Thank you..

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Great. I’ll have Joanne Donovan, our CMO address the enrollment question around CAT-1004..

Joanne Donovan

Yes. We have been very gratified with the results of enrollment with the patients who were already in the study as well as interest from other patients as well. So we are confident in our ability to enroll the study and get to top line results at the end of the year..

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Great. And for your second question with regard to CAT-2054 and initiating a Phase 2b trial in NASH, so clearly we will wait and see the results of the Phase 2a study, which will read around the midyear and we’re certainly eager to see that.

We’re also working toward longer-term talks studies which are ongoing as well as preparing materials for the next clinical step. So, certainly more to come with regard to the timing of the next step..

Unidentified Analyst

Okay. Thank you..

Operator

Thank you. And our next question comes from the line of Phil Nadeau of Cowen. Your line is now open. Please go ahead..

Phil Nadeau

Good afternoon. Thanks for taking my questions.

Couple on 2054, just on the safety profile give a sense of what level of GI adverse events would be acceptable based on your work with advisors?.

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Yeah. This Jill, I will let Joanne take that question..

Joanne Donovan

I think that we have had an excellent safety and tolerability profile to date and so I think that you are going as of course this is a long-term indication and we need to have a good safety and tolerability profile and that is our expectation for the study to be consider successful..

Phil Nadeau

Okay.

Great and then, second as we think about possibly moving forward to NASH, what population of patients would be most appropriate, would be early stage pre-Socratic or is there a way it actually help Socratic patients?.

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Yeah. This is Jill and maybe I’ll start and then let Joanne finish.

I think what we’re right now is obviously evaluating closely the data that we’ve generated from our preclinical studies in NASH and also would be waiting to see the Phase 2a results, but in addition to that we’re actively in conversation with experts in the NASH field to really address what is the right target patient population for this agent.

Certainly what we’ve seen pre-clinically and the effects we’ve seen. We believe they are going to have broad potential in the NASH patient population, but certainly will be embedding what the best plan for it is there. I don’t’ know if Joanne wants to add any more color to that..

Joanne Donovan

I don’t have much to add to that. We were very pleased to see the data on ballooning degeneration and fibrosis because those are key to the preventing or treating more advanced NASH. So, we want to see that we have effects potentially across the spectrum and then we work with the experts. We’ve been talking with about designing the best next trial..

Phil Nadeau

Okay, great. And then, just one last question, you build your 2054 to lower LDL. I believe in earlier trials you saw a somewhat unique time course for LDL lowering or would actually continue to maybe even increased after dosing, correct me if I’m wrong.

Could that be captured in the structure the current study, whether you will be following patients post dosing and have you done any work on the mechanism of that unique time course?.

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Yeah. That’s a great question. You remember it correctly.

So certainly what we did see was statistically significant reductions in LDL cholesterol after 14 days dosing and those effects grew in out to 7 day post that dosing and we think that maybe related to actually the mechanism here and that we’re inhibiting SREBP, which is really a master homeostatic regulator of lipid metabolism and so you might anticipate that the affects would grow in overtime and indeed that’s what we’ve seen.

We’ve designed our phase 2a study to capture that as well. So it’s obviously four weeks in duration of dosing with CAT-2054. We’ll have a follow-up, a 21-day follow-up period post that as well to follow those kinetics because something were very interested and understanding.

And of course as we think about next steps for this program clinically it’s obviously longer term studies because we really truly think with this type of the mechanism inhibiting a homeostatic regulator that it might take time to really get the full effects of that in addition. So that’s certainly something we’re addressing..

Phil Nadeau

Great. Thanks for taking my questions..

Operator

Thank you and I’m showing no further questions at this time. I would now like to turn the call over Ms. Jill Milne for closing remarks..

Jill Milne Co-Founder, Chief Executive Officer, President & Director

Great, thank you. Thank you operator and thank you to everyone for being on the call today. In summary, already in 2016 we have completed enrollment for the Phase 2a trial for CAT-2054 ahead of schedule.

We’ve presented positive MoveDMD Part A trial results for Edasalonexent including demonstrating NF-KB target engagement in boys Duchenne and MoveDMD Part B is underway after what we deal is collaborate with such interactions with the FDA.

We believe each of our Phase 2 programs has the potential to be transformative in the treatment of the diseases they target and each offers a strong value proposition in its own right. We published aspects of our SMART linker drug discovery platform in the journal of Medicinal Chemistry.

We received grant funding from MDA to support MoveDMD Part B, as well as The Friedreich’s Ataxia Research Alliance in support of CAP-4001 research; and two distinguished members have been added to the Catabasis board of directors along with the formation of the Science and Technology Committee.

We expect to report top line Phase 2a result of CAT-2054 around midyear and top line results for Part B of the MoveDMD trial for Edasa late this year. We believe these readouts represent two non-core related short term goals. Ones in which our confidence has always been high and has increased since our last call. Thanks to new data.

Thank you everyone for joining us on today’s call and thank you for your support and interest in Catabasis.

Andrea?.

Andrea Matthews Chief Business Officer

That concludes today's call. A webcast replay will be available for 90 days via the Investor Relations page on our website at www.catabasis.com. Thank you..

Operator

Ladies and gentlemen, thank you for participating in today's conference. This concludes today’s program. You may all disconnect, everyone have a great day..

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