BioVie (OTCQB:BIVI) received clearance from the US Food and Drug Administration (FDA) to begin a Phase 2a clinical trial for their drug candidate BIV201.
As quoted in the press release:
A second key milestone was achieved when BioVie was notified by the US Patent and Trademark Office (USPTO) that its application for a core patent covering the use of BIV201 to reduce ascites formation in ambulatory patients has been allowed. This application was based on proprietary ascites patient data provided by the Company’s medical advisor Paolo Angeli, MD, a leading global expert in this field, and licensed from the University of Padova, Italy, where he practices medicine. The US patent is expected to issue within 45 days at which time more details will be reported. The Company continues to pursue patent issuances in Japan, China, and possibly European and other countries.
Additionally, BioVie is pleased to announce that it has met all of the conditions needed to commence the previously announced $12 million common stock purchase agreement with Aspire Capital Fund, LLC. Any funding received under the Aspire agreement will help to support the start of the Phase 2a clinical trial mentioned above and be used for general corporate purposes.
“These represent three major advances for the Company and strongly support the BIV201 clinical development program,” commented BioVie CEO Jonathan Adams. “They’re the culmination of many months of effort by our IND and management teams. We are excited about taking the next steps as our compound enters the clinic. Although the primary focus will be on safety and pharmacokinetics, we are also hoping to see signs of disease improvement in severely ill ascites patients.”
The Phase 2a clinical trial will consist of a small number of patients in an open-label study at a single US-based medical center, and is expected to take about 8 months. Eligible patients will have cirrhosis with ascites requiring large-volume paracentesis who are refractory to or unable to tolerate diuretic therapy. Pending the outcome of this first study, BioVie plans to follow with a larger placebo-controlled Phase 2 study.
About BioVie Inc.
BioVie Inc. is a clinical-stage company pursuing the discovery, development, and commercialization of innovative drug therapies. The Company is currently focused on developing and commercializing BIV201, a novel approach to the treatment of ascites due to chronic liver cirrhosis. In March 2017, BioVie received notification from the FDA that it could initiate a Phase 2a US clinical trial. BIV201 has the potential to improve the health of thousands of patients suffering from life-threatening complications of liver cirrhosis due to hepatitis, NASH, and alcoholism. It has Orphan Drug designation for the most common of these complications, ascites, which represents a significant unmet medical need. The FDA has never approved any drug specifically for treating ascites. For more information about BioVie and BIV201, please visit our website: www.biovieinc.com.