FDA accepts Hepion’s IND application for CRV431 to treat Covid-19

The US Food and Drug Administration (FDA) has accepted Hepion Pharmaceuticals’ investigational new drug (IND) application for its CRV431, a novel cyclophilin inhibitor, to treat Covid-19.

In July this year, the company revealed a potential two-pronged strategy for the treatment of Covid-19. First, preclinical cell culture experiments shown CRV431 reduced SARS-CoV-1 production of infectious virus,

Second, CRV431shown attenuated lung inflammation and damage similar to or better than dexamethasone, including reductions in neutrophils and IL-6, in a non-viral and acute lung injury model.

At present, CRV431 is under clinical-phase development for the treatment of non-alcoholic steatohepatitis (NASH).

The novel cyclophilin inhibitor is expected to play a significant role in the overall treatment of liver disease ranging from triggering events through to end-stage disease.

Hepion CEO Dr Robert Foster said: “Clearance of the Covid-19 IND by the FDA speaks to the versatility of CRV431, a novel orally active cyclophilin inhibitor.

“Even with the decades of experience our core team has with the research and development of this specialized drug class, we continue to be amazed at the number of diseases that could potentially benefit from inhibiting cyclophilins.”

Hepion designed an artificial intelligence (AI) platform known as AI-POWR, which enables to identify which NASH patients will respond more to CRV431.

The company will also use the platform to detect additional potential indications for CRV431 to expand its footprint in the cyclophilin inhibition therapeutic area, in addition to advance its ongoing Phase 2a NASH programme.

Recently, Moderna’s mRNA-1273 vaccine has been granted emergency use authorisation (EUA) by the FDA for the prevention of Covid-19.

As per the EUA, the mRNA-1273 vaccine can be administered to individuals aged 18 years or older.