On April 3 BioVie Inc. (OTC:BIVI) announced that the FDA had accepted their investigational new drug (IND) application for BIV 201. BioVie will shortly commence with its Phase IIa clinical trial for BIV 201, which is a compound intended for the treatment of ascites due to liver cirrhosis, as well as other conditions related to liver cirrhosis. In early 2016, the company held a pre-investigational new drug meeting with the FDA to develop a study for patients with refractory or intractable ascites due to advanced liver cirrhosis. This was followed by the FDA granting orphan designation in September 2016, and an IND filing in November 2016. After adding some modifications recommended by the agency in early 2017, BioVie now expects to launch the trial in the next months, following a period of patient recruiting.
The study will involve a small number of patients in a US-based open label study that should be completed in approximately eight months. Eligibility criteria requires patients to have cirrhosis with ascites and large volume paracentesis. Eligible enrollees must also be refractory to or unable to tolerate diuretic therapy. If results from the trial are favorable, the company will continue with a Phase IIb study that will enroll more patients in a randomized, placebo control design.
In addition to the FDA notice, the US Patent and Trademark Office allowed the registration of BioVie’s patent covering BIV 201 for reducing ascites formation in ambulatory patients. We expect that the patent will be issued in the next month or two related to the infusion of continuous low-dose BIV 201 for ascites patients.
Achieving the uplisting the stock to the OTCQB market has satisfied the requirements for BioVie to receive the $12 million in investment with Aspire Capital that was agreed to in a January 4, 2017 common stock purchase agreement. Now that the trial may move forward, BioVie may access the $12 million from Aspire over the 30 month term of the agreement as per the details outlined in the BIVI’s latest 10- filing. The funds will support the development of the Phase II trials and set the stage for further studies if outcomes are favorable. This funding is expected to be sufficient to support both the Phase IIa and anticipated IIb trials.
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