Seeking Alpha

3 Things In Biotech, April 16: Liver, Liver, And More Liver

Includes: ICPT, MNOV, RIGL
by: Zach Hartman

MediciNova makes a big move in NASH.

BerGenBio and Rigel tee up preclinical findings at EASL.

Intercept's substudy shows promise for biliary cholangitis.

Note: Subscribers to Avisol Capital Partners Total Pharma Tracker got an early look at this publication. Try for free today and see what we're talking about!

Welcome to another edition of "3 Things In Biotech You Should Learn Today," a daily digest dedicated to helping you keep pace with the fast-moving world of pharmaceutical and biotechnology research.

MediciNova makes a big move in NASH

Company: MediciNova (MNOV)

Therapy: Tipekulast

Disease: Non-alcoholic steatohepatitis (NASH)

News: MNOV presented positive findings from a phase 2 study evaluating their antifibrotic, anti-inflammatory agent tipekulast in patients with NASH and non-alcoholic fatty liver disease at EASL 2018. As of the interim data readout, the study met its primary endpoint of reducing mean serum triglycerides, on average achieving a 28.8% reduction. On the basis of meeting this endpoint, the study has been terminated to accelerate development of tipekulast.

Looking forward: This is good news for tipekulast overall, as more rapid development would potentially launch MNOV into an increasingly competitive field relatively quickly. The market ultimately did not receive this news well, leading to an almost 5% decline in the valuation of the company after early gains. However, the news in itself is positive, so this could represent a near-term buying opportunity. Of course, the news was known a bit earlier, so it may be that shareholders are not in agreement that the data are momentous.

BerGenBio and Rigel tee up preclinical findings at EASL

Company: BerGenBio and Rigel (RIGL)

Therapy: Bemcetinib

Disease: NASH

News: BerGenBio presented preclinical data on the use of the AXL inhibitor bemcetinib for treatment of fibrosis related to NASH. The study showed that in preclinical models serum levels of AXL were an early marker of the disease that seems to be associated with worse prognosis. In cell lines, activation of AXL induces signaling that encourages fibrosis, and bemcetinib was able to reduce liver fibrosis in a mouse model of NASH.

Looking forward: Obviously this is very early work, but there has been a lot of work over the past decade to see where AXL inhibitors might be able to fit into the standards of care for various diseases, including NASH and cancer. BerGenBio announced in the same press release that they will be presenting positive findings in idiopathic pulmonary fibrosis as well. So overall, while it's too early for me to consider recommending a deeper dive, these are encouraging developments, for sure!

Intercept's substudy shows promise for biliary cholangitis


Intercept Pharmaceuticals (ICPT)

Therapy: Obeticholic acid

Disease: Primary biliary cholangitis

News: ICPT presented clinical data for their product candidate obeticholic acid at EASL 2018. These data came from an open-label extension of their phase 3 POISE trial. Most of the patients undergoing treatment with obeticholic acid maintained or improved their histologic fibrosis staging, providing evidence of long-term control of advanced-stage disease.

Looking forward: After ICPT's snafu with the FDA back in February over the dosing of this drug (which led to a change to the package insert to encourage proper dosing among healthcare providers), this kind of news is very welcome, although it was in a small cohort of patients. A demonstration of longer-term control of fibrosis is very helpful for assuaging any patient or doctor fears about potential safety concerns of obeticholic acid. In the case of this extension study, nothing new or alarming was observed on the safety side either. So overall, this is quite good news for ICPT.

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.