BioVie Inc (NASDAQ:BIVI) has presented data from its Phase 2b trial evaluating the efficacy and safety of its drug candidate BIV201 for liver disease at The American Association for the Study of Liver Diseases – The Liver Meeting in Boston, Massachusetts.
The company said the trial showed that BIV201 in combination with the standard of care in patients with refractory ascites due to cirrhosis was well tolerated with no major difference in treatment-emergent adverse events when compared to the standard of care alone.
Ascites is a common complication arising from advanced liver cirrhosis in which large volumes of fluid accumulate in the abdomen due to liver and kidney dysfunction. There is currently no approved therapy specifically for this condition.
BioVie also reaffirmed that it is commencing a Phase 3 trial in the second quarter of 2024.
“Our Phase 2b results mark a significant step toward providing a treatment for cirrhosis patients with refractory ascites, of whom face a survival rate as low as 50% within a year of diagnosis,” BioVie CEO Cuong Do said.
“Currently, the only options for these patients are transjugular intrahepatic portosystemic shunt (TIPS) surgery or liver transplantation, which are invasive and come with numerous potential life-altering complications.
“These data being presented, coupled with statistically significant efficacy, allowed BioVie to halt the trial prior to completion and further strengthen our confidence in accelerating BIV201’s development into Phase 3 trials, which we expect to initiate in 2Q 2024.”
In addition to presenting its Phase 2b BIV201 data at The Liver Meeting 2023, the company said it expects to release the unblinded data from its Phase 3 trial of its candidate NE3017 for Alzheimer’s disease in late November or early December.
BioVie is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on X, formerly known as Twitter, @emilyjjarvie