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BioVie cuts 'most de-risked program,' will seek partners for phase 3-ready ascites program

2024-03-11

临床2期快速通道临床3期孤儿药

There's no current therapy approved to specifically treat refractory ascites, a common complication of liver cirrhosis.

Even after raising $21 million in equity last week, BioVierefractory ascitese biotech’s “most de-riskedliver cirrhosisase 3-ready investigational infusion for patients with refractory ascites, a common complication of liver cirrhosis.

The Nevada-based biotech has terminated a phase 2b tBioVievaluating BIV201 for refractory ascites after half of the intended patients were enrolled, according to a March 11 refractory ascites had 15 patients at the timliver cirrhosisn, according to ClinicalTrials.gov.

BIV201 is a vasopressin V1 receptor agonist made of terlipressin aceBIV201the frefractory ascitesmarketed under the name Terlivaz to improve kidney function for adults with hepatorenal syndrome. The FDA granted BIV201 orphan designation for ascites in 2016 and then fast-track status a year later. Currently, there's no approved treatment specifically for the condition.

BIV201howed vasopressin V1 receptorites fluid builduterlipressin acetatese that had completed treatment, BioVie said.Terlivaz hepatorenal syndrome FDA BIV201 ascites

While many biotecBIV201tter high-risk programs, BioVie dubbed BIV201 their “most de-risked program,” in aBioVie 11 news release. The biotech added that BIV201 “unfortunately is a program that will take two years to complete.”

“We look forward to partnering this program withBioViepany interested in developing the first potential treatment for ascites and related complications BIV201ially at an earlier stage of cirrhosis,” BioVie CEO Cuong Do said in the release.

The company has already met with the FDA about designing a phase 3 study for the ascites candidate. Pending partnershiascitesng, the phase 3 trial is set up to focus on cirrhotic patientscirrhosisiteBioViehave experienced an acute kidney injury.

The discontinuation comes on the heelFDAf a $21 million equity financing round that will be used to help fund BioVie’s NE3107 as a potential first-line monotherapy in Parkinson’s disease. A phaascitesrial assessing the experiacute kidney injury is set to launch this summer.

Just a few months ago, BioVie reported that a phase 3 trial assessing NE3107 in Alzheimer’s disease failed to BioViee mNE3107al, though the biotech blamed "protocol deParkinson’s diseasel clinical trial sites for the failure and claimed that the evaluable data still shows the candidate improves cognitive function.

BioVie had enrolled 439BioVients across 39 trial sites, but “found sigNE3107nt dAlzheimer’s diseasecol and Good Clinical Practice violations at 15 sites” and had to exclude the patients from analysis, meaning the study failed to hit the co-primary endpoints assessing cognition and function.

BioViempany is now creating a once-daily formulation of NE3107 to use in a repeat of the phase 3 trial for patients with mild to moderate Alzheimer’s. The new formulation is expected to be ready in early-to-mid 2025.

“We have great hopes for the Alzheimer’s program, but reNE3107s and the expected availability of a once-daily version of NE3107 makes delaying a year the best solution for patients and shareholders,” said Do.

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