Hepion evolved from Contravir in 2019. What was the thought process behind the change?

The name change reflects a transformation in the strategic direction of the company. In 2016, the main focus of the company was anti-virals, namely the treatment of hepatitis B and a treatment for shingles. I was asked to take over as a CEO of Contravir in October of 2018 and made a review of our products and take a strategic view of where the market was going and where the opportunities were to maximize shareholder value. I decided to halt the development of our late stage developments and emphasize the early stage program, which is centered on the CRV431 molecule. The data was telling us that we had a molecule that had very strong anti-fibrotic properties and I wanted to see if the molecule could be developed further, initially in the indication of liver disease and specifically in non-alcoholic steatohepatitis – also called NASH.

Can you give us an update on the development process of CRV431?

CRV431 now has two IND (Investigational New Drug) applications that have been accepted by the FDA. The first IND was for hepatitis B virus (HBV) and the second was for NASH – the latter is the indication we are pursuing now. We have completed the pre-clinical program. The package is complete and we have conducted a phase 1 single ascending dose study in human volunteers and are now conducting a multiple ascending study in healthy volunteers. We are getting ready to enter into a proof of concept phase 2 in NASH in 2020. We have made a lot of progress in the clinic and in non-clinical studies.

CRV431 is an anti-fibrotic drug and we are focused on its application for NASH. If the anti fibrotic mechanism continues to be strong, which I believe it will, it may be used in other anti-fibrotic indications. To that extent, about 45% of all the death that occurred in the developed world has some type of fibrosis component.

Can you comment on the obesity epidemic and how it is driving the need for medical solutions to fatty liver disease?

Obesity is a global problem and fatty liver disease can affect as many as one in four of the population. Of those, some will go on to develop NASH, which is a more aggressive form of non-alcoholic fatty liver disease. NASH may affect up to about 12% of the US population.  It is vitally important that we develop solutions to treat the global population for this epidemic of fatty liver disease and NASH. If we do not find good treatments for liver disease, the outcome will be severe with increased morbidity and mortality from cardiovascular disease and liver related events such as liver transplantation and liver cancer.

With the clinical studies for CRV advancing steadily, what are the company’s plans and milestones for 2020 and beyond?

One of our key events slated for the first half of 2020 is the completion of our multiple ascending dose study of CRV431.  We will also initiate a phase 2 proof of concept, a short study that is only 28 days long. We will be looking for safety, tolerability as well as biomarkers for NASH and fibrosis. We will be monitoring specific markers to determine to what extent we may anticipate how these will behave in a longer NASH study. This study will prepare us not only for our longer phase 2 program, but also for our phase 3 program.  

What is your final message to the pharmaceutical and investment community about why they should be interested in Hepion?

People should pay attention to Hepion because this is a company that is truly undervalued. My previous company, Aurinia Pharmaceuticals, was under-valued for a long time. More recently, however, investors paid attention to our previous drug, Voclosporin, for the treatment of lupus nephritis and have now driven the company’s market cap to over US$2 billion. When I look at Hepion, which is approximately only US$20 million market cap, I believe that CRV431 is at least as good as Voclosporin and addresses a market that is much larger than lupus nephritis. I believe the upside is very substantial in terms of both CRV431’s potential in NASH fibrosis and market value.