Business
BioVie Advances the BIV201 Clinical Program and Prefilled Syringe
Novel BIV201 Formulation Shows Significant Improvements Over Industry TerlipressinPrefilled Syringe May Significantly Extend Market Protection Beyond Orphan
About this update from Biovie Inc.
[{"type":"text","content":"Novel BIV201 Formulation Shows Significant Improvements Over Industry TerlipressinPrefilled Syringe May Significantly Extend Market Protection Beyond Orphan Drug Exclusivity\n SANTA MONICA, Calif., June 11, 2020 (GLOBE NEWSWIRE) -- BioVie Inc. (OTCQB: BIVI) (“BioVie” or “Company”), a clinical-stage company developing innovative drug therapies for liver disease, announced today that following the company’s successful Phase 2a study, it has received guidance from the US Food and Drug Administration (“FDA”) regarding the next clinical trial design for BIV201 (continuous infusion terlipressin) in patients with refractory ascites due to liver cirrhosis. The Company plans to commence a randomized 24-patient Phase 2 study this year, to be followed by a larger pivotal Phase 3 clinical trial targeted to begin the first half 2021. The FDA has communicated that pending positive Phase 2 study results, a sufficiently large and well-controlled Phase 3 trial, with supportive data from the Phase 2 (statistical significance not required), could potentially yield the clinical data needed to apply for BIV201 marketing approval. The Company estimates that the pivotal Phase 3 study will involve approximately 120 ascites patients. Terren Peizer, BioVie Chief Executive Officer, stated, “We appreciate the FDA’s detailed guidance for planning the next BIV201 clinical trial in ascites patients who are seriously ill and often hospitalized with life-threatening complications of their disease. The primary goal of the upcoming Phase 2 study will be to reduce the occurrence of dangerous complications linked to refractory ascites, which is the accumulation of large volumes of fluid in the abdomen no longer responding to off-label diuretic therapy. We anticipate that the pivotal Phase 3 trial design will mirror the Phase 2 study design. Based on our US Phase 2a trial results and global studies, we believe that our Orphan Drug candidate BIV201 has the potential to greatly relieve the suffering of ascites patients and improve their health outcomes.” Importantly, BioVie may use the new patent-pending BIV201 prefilled syringe in the upcoming Phase 2 trial subject to conducting certain additional standard analytical testing that is expected to take approximately two weeks. Room temperature stability of the prefilled syringe has been confirmed at 6 months, with the p...