Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Q3 2016 Earnings Conference Call - Preliminary Transcript

Nov 03, 2016 • 08:30 am ET


Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT) Q3 2016 Earnings Conference Call - Preliminary Transcript


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Operator Thank you for joining the Intercept Pharmaceuticals Third Quarter Results Conference Call. At this time, all participants are in a listen-only mode. Following opening remarks, Intercept management will open the lines for a question-and-answer period. Please be advised that this call is being recorded at the company's request and a webcast of this call will be archived on the companys website for two weeks from todays date. At this time, I would like to introduce Dr. Mark Vignola, Intercepts Director of Investor Relations. Please go ahead.

Mark Vignola

Years and while we have a strong interest from both physicians and patients, it will take time to educate the market about the risk of the patients with elevated outline phosphatase levels despite UDCA treatment. This will require a continued dedicated effort and Richard will shortly provide you with more details on the progress we are making. Moving now to our NASH program, where our Phase III trial REGENERATE remains a top priority for the company.

As a reminder, REGENERATE is a large complex trial involving serial liver biopsies. We continue to strive for the completion of enrollment of our interim analysis cohort within the first half of 2017. However, in order to achieve this guidance, we need to continue to increase our enrollment rate. With this goal in mind, we have been implementing a number of operational initiatives and are also evaluating several available options to maintain our timelines. With respect to control, we are happy to announce today that we have completed our target enrollment of more than 80 NASH patients with fibrosis and we will shortly reclosing our patient randomization.

As a reminder, this trial was a 16 week placebo controlled trial evaluating three doses of OCA 5 milligrams, 10 milligrams and 25 milligrams. The trial is prospectively evaluating the impact of statin therapy added to OCA on LDL and the effect of OCA on lipid metabolism. Across our other programs, we are also making good progress. As I mentioned earlier, we completing enrollment in our Phase II AESOP trial of OCA and PSC in September of this year. As a reminder, AESOP is a 24-week placebo controlled trial evaluating two titrated doses of OCA. 1.5 milligrams to 3 milligrams and 5 milligrams to 10 milligrams titration occurring filtration occurring at 12 weeks. The primary endpoint is to evaluate change in our this trial is the first clinical experience we will have with those CA and PSC. A devastating disease with no approved treatment options and a more complicated course compared to PBC.

Finally, we are just a little over a week out from the AASLD meeting the key U.S. medical meeting in liver disease. For us, this year AASLD will be the first as a commercial stage company, where we will be able to talk about Ocaliva and present our new branded materials. We expect a key highlights of the meeting to be new data from the Phase III POISE trial, which will provide more information on those OCAs treatment