CARSON CITY, Nev. - BioVie Inc. (NASDAQ:BIVI), a clinical-stage biopharmaceutical company, has announced the completion of a financing round that will support the advancement of its clinical programs, particularly for Parkinson’s Disease (PD) and Alzheimer’s Disease (AD).
The company has raised approximately $18.8 million in equity financing, with gross proceeds of $21 million, enhancing its cash position to progress its therapeutic development plans.
BioVie presented data at the recent International Conference on Alzheimer’s and Parkinson’s Diseases 2024, demonstrating that PD patients treated with their drug candidate NE3107 showed significant improvements in symptoms.
Based on these results, BioVie is finalizing plans for a Phase 2b trial of NE3107 as a first-line monotherapy for newly diagnosed PD patients. The trial, aiming to enroll 100-150 patients, is slated to begin in late summer 2024 and will utilize a Bayesian design to potentially expedite results.
For its AD program, BioVie intends to leverage a once-daily formulation of NE3107, expected to be available early-to-mid 2025, to conduct a repeat Phase 3 trial in patients with mild to moderate AD. The decision to delay the AD trial until the new formulation is ready is seen as a strategic move to improve treatment adherence and outcomes.
The company also provided an update on its BIV201 program for the treatment of ascites due to chronic liver cirrhosis. Although the Phase 2b trial for BIV201 was terminated after enrolling half of the intended patients, the data indicated a reduction in ascites fluid buildup. BioVie has received guidance from the FDA to finalize the design of the Phase 3 protocol, with the trial focusing on an earlier stage of disease progression.
BioVie’s President and CEO, Cuong Do, expressed optimism for the PD program, citing the potential to introduce the first new therapy for the condition since levodopa. While the BIV201 program is considered the most de-risked, its completion is anticipated to take two years, and the company is seeking partnership funding.
The company’s drug candidates aim to inhibit inflammatory activation that leads to neuroinflammation and insulin resistance, common drivers of neurodegenerative diseases. BioVie’s efforts in developing treatments for neurological and neurodegenerative disorders and advanced liver disease continue, with the recent funding set to bolster their clinical initiatives.
This report is based on a press release statement from BioVie, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.