BioVie Hosting Research & Development Day

Rhea-AI Summary

BioVie Inc. (NASDAQ: BIVI) announced a research and development day on May 19, 2021, featuring discussions on its lead pipeline assets: NE3107 and BIV201. NE3107 is a first-in-class treatment for Alzheimer's and Parkinson's diseases and is set for a pivotal Phase 3 study this summer. BioVie plans to acquire NE3107 from NeurMedix, with the transaction expected to close in June. BIV201, an Orphan drug candidate for ascites treatment, is in a Phase 2b study and has received FDA designations for expedited review.

Positive

• NE3107 has successfully completed multiple pre-clinical and clinical studies, indicating strong potential for treating inflammatory diseases.
• BIV201 has received Orphan Drug and Fast Track designations, enhancing its market prospects.
• BioVie is addressing significant unmet medical needs with its drug candidates.

Negative

• None.

SANTA MONICA, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) ("BioVie" or "Company"), a clinical-stage company developing innovative drug therapies for the treatment of liver disease and neurological and neuro-degenerative disorders and certain cancers, today announced that it will host a research and development day on Wednesday, May 19, 2021 from 12:00pm – 2:00pm Eastern Time.

The event will feature an in-depth discussion from the BioVie management team on their two lead pipeline assets: NE3107 for the treatment of Alzheimer’s Disease, Parkinson’s Disease and various cancers, and BIV201 (continuous infusion terlipressin) for the treatment of ascites due to liver cirrhosis and other liver diseases.

NE3107 is a selective inhibitor of inflammatory ERK signaling that reduces neuroinflammation. It is an orally administered first-in-class small molecule that inhibits inflammation-driven insulin resistance and major pathological inflammatory cascades with a novel mechanism of action. BioVie recently announced its intention to acquire NE3107 from privately held NeurMedix Inc in a transaction expected to close in June. A pivotal Phase 3 Alzheimer’s study with NE3107 is expected to begin this summer.

BIV201 (continuous infusion terlipressin) is currently being evaluated in a US Phase 2b clinical study and has received Orphan Drug and Fast Track designation for the treatment of ascites due to advanced liver cirrhosis. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan.

To register for the research and development day, please click here.

About BioVie, Inc.

BioVie Inc. (“BioVie”) is a clinical-stage biopharmaceutical company that engages in developing products for the treatment of liver disease and, pending closing of the announced transaction with NeurMedix, neurological and neuro-degenerative disorders and certain cancers. The company’s lead clinical drug candidate to be acquired from NeurMedix, NE3107, has successfully completed 11 pre-clinical, and 6 Phase 1, Phase 1/2, and Phase 2 clinical studies in various inflammatory diseases indicating its broad potential to inhibit inflammatory cascade without evidence of immunosuppression. In addition to Alzheimer’s Disease, BioVie plans to enter clinical trials for the treatment of Parkinson’s Disease and several oncological indications. The Company is focused on diseases with significant unmet medical needs and commercial potential in order to expedite FDA review, minimize capital requirements and optimize shareholder value.

BioVie is also developing BIV201 (continuous infusion terlipressin) an Orphan drug candidate for the treatment of ascites due to advanced liver cirrhosis. First-to-market Orphan therapies typically receive 7 years of market exclusivity in the US for the designated use. The initial disease target for BIV201 therapy is ascites, which is a serious complication of advanced liver cirrhosis, and future development opportunities include hepatorenal syndrome (HRS) and other life-threatening complications. The Company recently initiated patient screening in its second US Phase 2 clinical trial, and upon completion will commence a pivotal Phase 3 trial shortly thereafter. The trial design is summarized on www.clinicaltrials.gov, trial identifier NCT04112199. The FDA has never approved any drug specifically for treating ascites, and the Company is not aware of any competing drugs in late-stage development for ascites. The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. For more information, visit http://www.biovieinc.com/.

CONTACTS:

INVESTOR RELATIONS:
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com

FAQ

What are BioVie's lead drug candidates as of May 2021?

BioVie's lead drug candidates are NE3107 for Alzheimer's and Parkinson's diseases, and BIV201 for treating ascites due to liver cirrhosis.

When will BioVie host its research and development day?

BioVie will host its research and development day on May 19, 2021, from 12:00pm to 2:00pm Eastern Time.

What clinical studies is NE3107 involved in?

NE3107 is expected to begin a pivotal Phase 3 study for Alzheimer's Disease in summer 2021.

What designations has BIV201 received?

BIV201 has received Orphan Drug and Fast Track designations from the FDA.

Who is responsible for the acquisition of NE3107?

BioVie has announced its intention to acquire NE3107 from NeurMedix, with the transaction expected to close in June 2021.