BioVie Inc (NASDAQ:BIVI) told investors it has secured sufficient funds through a recently completed financing to progress its near-term clinical priority, developing its lead asset NE3107 for Parkinson’s disease.
It increased its cash balance by approximately $18.8 million after closing an equity financing round last week for gross proceeds of $21 million.
The company said it is finalizing a Phase 2b trial of NE3107 as a first-line monotherapy for Parkinson’s, targeting a launch in late-summer 2024.
It intends to enroll 100 to 150 patients in the six-month study, with the primary endpoint being the Part 3 (motor) score on the MSD-Unified Parkinson’s Disease Rating Scale.
This comes after the company this past weekend presented data from a Phase 2a study which showed patients with moderate and severe Parkinson’s disease treated with NE3017 appeared to experience significant improvements in non-motor symptoms and motor control while placebo-treated patients worsened.
BioVie also said that it expects a once-daily NE3107 formulation will be available in 2025, which will be used for a Phase 3 trial targeting Alzheimer’s disease.
The company said it believes this “more desirable presentation” of the drug will increase treatment adherence.
“Prioritizing the Parkinson’s program allows us to focus limited resources on the trial that should provide topline results by mid-2025, create a significant catalyst for the company, and potentially lead the way to the first new therapy for Parkinson’s disease since the advent of levodopa over five decades ago,” BioVie CEO Cuong Do said in a statement.
“We have great hopes for the Alzheimer’s program, but resources and the expected availability of a once-daily version of NE3107 makes delaying a year the best solution for patients and shareholders.”
Meanwhile, the company said it has terminated its Phase 2b trial of its clinical asset BIV201 in refractory ascites after the study enrolled one-half of intended patients as data available showed that BIV201 reduced ascites fluid buildup by over 50% in those that completed treatment.
It said it has received the feedback required from the US Food and Drug Administration to design a Phase 3 protocol, noting it potentially only needs to carry out a single late-stage trial due to BIV201’s having received Orphan and Fast Track designations from the agency.
The trial will focus on an earlier stage of the disease progression, after cirrhotic patients with ascites have experienced an acute kidney injury, to investigate if BIV201 can reduce the number of subsequent complications from cirrhosis and ascites.
“BIV201 remains our most de-risked program, but it unfortunately is a program that will take two years to complete,” Do said.
“We look forward to partnering this program with a company interested in developing the first potential treatment for ascites and related complications potentially at an earlier stage of cirrhosis.”
BioVie is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.