BioVie’s FDA Meeting Approaching Rapidly By Daniel Carlson - June 12, 2019
After releasing positive top-line results from their Phase 2a trial in late April, BioVie (BIVI) has been rather quiet. This is to be expected from a drug development Company with only one product in the current pipeline. Drugs take years to develop and milestones don’t occur every other week.
That silence is likely to change soon as a major milestone for BioVie is looming. As the Company has stated, they expect to meet with the FDA to share the results of the Phase 2a trial sometime during the first half of 2019; in other words, within the next two weeks. I expect we’ll hear something about the meeting shortly thereafter, although it can take a full 30 days before the FDA provides feedback to the Company.
What are they going to tell the FDA?
According to the Company, the trial met its primary objectives of this initial open-label study. The objectives were to assess the safety, tolerability, and steady state pharmacokinetics of terlipressin administered as a continuous infusion for 28 days to cirrhotic patients with refractory ascites.
As with any drug, the FDA is primarily concerned with safety, first and foremost. In order to progress into larger trials, a drug has to be proven to be safely administered and accepted by patients. The fact that the safety endpoints were met should help BioVie take their product to the next phase of trials.
On top of great safety data, CI Terlipressin demonstrated very compelling efficacy. Although this was in a small sample size of only six patients, with 67% showing great efficacy this is potentially meaningful and will be highlighted.
Also of significance to CI Terlipressin, BioVie’s results mirrored that of a larger study done recently in Australia. While the Company can’t submit that data, it will certainly be highlighted to the FDA. This is not unprecedented as the FDA will look at other corroboratory evidence in situations such as this.
What do they hope to get out of the FDA?
In meeting with the FDA, BioVie’s goal is to get go ahead for moving into a larger study. This is the pathway to approval for CI Terlipressin. We believe that, based on the data being presented, it’s highly likely they will receive approval to move forward.
The big question is what the design of the next trial will look like. Typically, a company would expect to launch a phase 2b trial, which will be smaller in size than a phase 3 and focus more on dosing than efficacy. Based on strength of their data, along with the drug’s Orphan status and Fast Track designation, there is a chance that BioVie will be able to win approval for a full phase 3 trial, meaning one large enough that it could possibly be powered to show efficacy from the results. This would accelerate the time to market substantially.
In general, getting the go-ahead to proceed with the next round of trials will be viewed positively in the market. Were they to get the nod on a phase 3, that would be a best-case scenario. However, even if they don’t get a full phase 3, there’s a highly likely chance an approved phase 2b could be rolled straight into a phase 3 trial which could then demonstrate efficacy and accelerate the FDA process.
It’s important to remember that there are no approved drugs for ascites in the US. Meanwhile, Terlipressin has been approved in numerous countries and is widely recognized as the best treatment for a patient group lacking options. With the newer delivery method of Continuous Infusion, the drug is safer and more well tolerated than when it underwent approval in multiple overseas jurisdictions.
Based on the trials to date, both here and abroad, we believe it’s highly likely that the FDA will progress CI Terlipressin to a phase 2b trial or better. As a result, we remain very positive on shares of BIVI and look forward to hearing more about the FDA meeting once it has transpired. Tailwinds' Disclaimers & Disclosures: For a full list of disclaimers and disclosures, please visit http://tailwindsresearch.com/disclaimer/.
DISCLAIMER: All I say is just IMHO and does not constitute investment advice. My wife informs me frequently that I know nothing. I say you should trust no one on the internet.
