Benzinga | Jun 23, 2021 08:02AM EDT

BioVie Receives FDA Guidance For Phase 3 Clinical Trial Of BIV201 In HRS-AKI; FDA Believes Results From Single Pivotal Phase 3 Trial Could Support NDA Filing

BioVie Inc. (NASDAQ:BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for the treatment of liver disease and neurological and neurodegenerative disorders and certain cancers, today announced the results of a Type B meeting request submitted to the Food & Drug Administration ("FDA") regarding its planned Phase 3 study of BIV201 (continuous infusion terlipressin) in hepatorenal syndrome--acute kidney injury ("HRS-AKI"). HRS-AKI is a life-threatening condition that may occur in patients with ascites due to advanced liver cirrhosis and has a mortality rate of approximately 50% over 2-4 weeks if left untreated. Based on communications with the FDA, the Company believes that positive results from a single pivotal Phase 3 clinical trial could potentially support the filing of a New Drug Application (NDA) and eventual approval of BIV201 for the treatment of HRS-AKI.

BioVie recently commenced a Phase 2b clinical study of BIV201 in ascites due to liver cirrhosis. Pursuing the development of BIV201 for HRS-AKI represents a strong strategic fit with the ascites program. Given the overlap of these serious complications in cirrhotic patients, our clinical team and expert medical advisors possess an in-depth understanding of HRS-AKI and the study can be conducted by the same clinical investigators at the same study centers as our ascites trial.

The Company's Chief Scientific Officer for liver cirrhosis, Penelope Markham PhD, commented: "We greatly appreciate the FDA's guidance for the HRS-AKI trial design. Based on their feedback, we plan to apply for a Special Protocol Assessment (SPA) to gain agreement on the key elements of the Phase 3 trial design prior to initiating the study. There are currently no FDA-approved treatments for any form of acute kidney injury and an approved treatment for the most severe form, HRS-AKI, could be transformative."