Hepion Pharmaceuticals Announces FDA Clearance of IND Application for CRV431 for COVID-19

IndustryPRwire -- Hepion Pharmaceuticals announced that the U.S. Food and Drug Administration ("FDA") has accepted its investigational new drug ("IND") application for CRV431, a novel cyclophilin inhibitor for the treatment of COVID-19.

On July 7, 2020, Hepion announced a potential two-pronged strategy to treat COVID-19. First, preclinical cell culture experiments demonstrated CRV431 decreased SARS-CoV-1 production of infectious virus. Second, in a non-viral, acute lung injury model, CRV431 demonstrated attenuated lung inflammation and damage similar to or better than dexamethasone, including reductions in neutrophils and IL-6. This property may be beneficial to patients suffering longer term consequences of COVID-19 infection, including acute respiratory distress syndrome ("ARDS"). Importantly, COVID-19 patients developing ARDS have a higher mortality rate.1 Taken together, this dual mode of action suggested that CRV431 may offer an opportunity to treat both the viral infection as well as lung injury in COVID-19.

"The recent identification of a mutational variant of SARS-CoV-2 that is potentially more infectious than previous strains is a reminder that we must continue to battle this virus on all fronts. Host cyclophilins play a key role in the propagation of viruses. CRV431, a cyclophilin inhibitor, interrupts the ability of the virus to use these human cyclophilins and thereby reduces viral propagation. As such, CRV431 is likely less prone to treatment resistance that may be seen when viral mutations occur," stated Dr. Daren Ure, Hepion's Chief Scientific Officer. "There is a great deal of well-deserved optimism now that vaccines have been approved. However, for the foreseeable future, we anticipate there will continue to be the need for active antiviral treatments as well as treatment for ARDS. CRV431 potentially offers both."

"Clearance of the COVID-19 IND by the FDA speaks to the versatility of CRV431, a novel orally active cyclophilin inhibitor," commented Dr. Robert Foster, Hepion's CEO. "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. The diverse roles that cyclophilins play in disease processes such as cell injury, inflammation, fibrosis, viral infections, and cancer are due to the actions of many different isoforms of cyclophilins. CRV431 inhibits several of these isoforms with similar potencies, which gives rise to its broad therapeutic potential."

Dr. Foster continued, "As part of the IND filing, Hepion provided data to the FDA from its previously completed Phase 1 studies of CRV431. Although Hepion's focus and lead indication remain squarely on the treatment of NASH, this IND may allow us opportunities to seek collaboration partnerships to support the initiation of Phase 2 studies of CRV431 for COVID-19, and to explore sources of non-dilutive external funding for our COVID-19 program."

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