Hepion Striving to Repeat History by Developing its Second FDA-Approved Drug

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

Non-alcoholic steatohepatitis (NASH) is one the most prominent liver diseases of our time. It is a severe form of nonalcoholic fatty liver disease that is caused by the accumulation of liver fat, which can lead to complications such as cirrhosis and liver cancer. If it leads to cirrhosis — leading to liver failure — you may need a liver transplant to survive.

Between 3% to 12% of adults in the U.S. (roughly 17 million) alone suffer from NASH. This is a statistic of epidemic proportions and yet there is no approved treatment.

Hepion Pharmaceuticals believes it can make a change with the development and eventual approval of CRV431, its lead oral drug candidate for the treatment of NASH.

What Makes CRV431 a Highly Versatile Therapeutic Drug?

CRV431 meets all of Hepion's criteria for an effective and unique pleiotropic (having multiple effects) liver disease drug. It is a novel molecule chemically derived from a pharmacological class of therapeutic drugs used clinically for over 35 years and has thus far demonstrated an excellent safety profile in all animal and clinical studies.

As a result of multiple, diverse mechanisms of action and its accumulation in the liver (5-times higher concentrations than in the blood), CRV431 has demonstrated efficacy in two distinct animal models of NASH and HBV replication. 

These findings are consistent with in-vitro studies documenting mechanisms of action as an antiviral agent, protection from cellular stress and death, anti-steatotic, anti-inflammatory, anti-fibrotic and anti-cancer activities. 

Hepion strongly believes that this makes CRV431 positioned to become a highly versatile therapeutic drug and that no other marketed drugs or NASH drug candidates in development address all these mechanisms.

All of Hepion's decades of expertise are based on human cyclophilins, a family of proteins named after their ability to bind to cyclosporin, an immunosuppressant used to prevent organ rejection in transplants. There are 17 types of cyclophilins, and Hepion's team has deep expertise and understanding in all aspects of them.

Hepion's History of Success

Hepion's advancements in the treatment of NASH are particularly promising because of the role of its research and development team in developing voclosporin, the only Canadian drug to be approved by the FDA in over a decade.

Voclosporin is an immunosuppressive drug for Lupus Nephritis being marketed under the brand name Lupykynis. It is one of only about 10 (made-in-Canada) FDA-approved drugs. The company's R&D team's discovery ended the Phase 2 clinical trial of the drug. 

Hepion recently raised $122.9 million to continue its programs. This raise was a reflection of the market's support and ongoing interest in the drug as a potential treatment for NASH and confirmation of the trust in Hepion's management team.

"Drug development is massively challenging," said Dr. Robert Foster, CEO of Hepion Pharmaceuticals. "We experienced this challenge first-hand over approximately two decades' research with our first drug that we discovered and developed, called voclosporin. It is the first oral drug ever to receive FDA approval for the treatment of lupus nephritis. Now, we aim to repeat our history and develop a second FDA-approved drug; this time for the treatment of NASH." He added, "To date, there are no FDA-approved drugs to treat NASH and CRV431 would represent a first-to-market oral once-daily product."

Upcoming Global Small Cap Conference

Dr. Foster and Vice President Dr. Patrick Mayo will be presenting at Benzinga's upcoming Biotech Small Cap Conference. 

Dr. Foster will provide an overview of its lead drug candidate CRV431 in the treatment of liver disease and NASH. The overview will provide a background of the discovery of CRV431, cyclophilins, the role of machine learning, Hepion's clinical programs and plans for the future.

Dr. Mayo will provide an overview of AI bioinformatics in drug development. This overview will discuss "big data analysis" and understanding of multi-omics — how it can be linked to preclinical and clinical data that will enrich study design and provide a priori analysis. This analysis can determine patients who will best respond to Hepion's lead drug candidate for CRV431 to treat NASH.

To catch the latest information from Hepion Pharmaceuticals at the upcoming Biotech Small Cap Conference, sign up to participate here.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.