BIVI - BioVie pauses mid-stage trial for ascites candidate after encouraging data

2023-03-13 13:59:32 ET

Clinical-stage biotech BioVie ( NASDAQ: BIVI ) announced Monday that the company halted patient enrollment in Phase 2b clinical trial for ascites candidate BIV201 after generating "compelling" data from its first 15 patients.

The study is designed to evaluate BIV201 combined with standard-of-care (SOC) against SOC alone in patients with refractory ascites, a common complication of advanced liver cirrhosis, and a condition with no FDA-approved therapies.

Ascites, characterized by fluid accumulation in the abdomen, has a one-year survival rate of 50% when the disease progresses to the refractory stage.

According to the company, during 28 days after the treatment initiation, BIV201 plus SOC led to a 34% reduction in ascites fluid compared to 28 days before the treatment (p=0.0046).

Meanwhile, those who received SOC only were found to have a mean increase of 3.1% in ascites fluid. Those who were treated with BIV201 showed a 53% reduction.

In terms of safety, the treatment was well tolerated, with no unexpected serious adverse events. BioVie ( BIVI ) expects to share detailed results at a future medical conference.

"Compelling data from the first 15 patients led us to pause enrollment," Chief Executive Cuong Do said, adding that "given the high unmet need for this condition, we believe the most prudent course is to initiate conversations with the FDA" to advance BIV201 to a pivotal Phase 3 trial. "….so that we can bring this innovation to patients as quickly as possible," he added.

Seeking Alpha contributor Avisol Capital Partners issued a Hold rating on BioVie ( BIVI ) in February, citing the stock's recent volatility and concerns over the company's liquidity.

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