Revive Therapeutics has extinguished its phase 3 COVID-19 trial after an interim look at the data showed it was on course to fail. But the biotech still thinks it can resuscitate the drug program, telling investors it believes the data could support talks with the FDA about the next steps.
The study randomized patients with mild to moderate COVID-19 to receive the antirheumatic molecule bucillamine or placebo three times a day for 14 days. Revive hoped to show bucillamine cuts the proportion of patients who are hospitalized or die in the 28 days after starting treatment. After looking at the data to date, an independent data safety monitoring board thinks that is unlikely to happen.
As Revive put it, the board “recommended that the study be halted early due to statistical significance of the primary endpoint likely not going to be met should the study continue towards completion.” Revive responded by halting the trial, positioning it to unblind and start evaluating the data.
The biotech plans to look at the data on COVID-19 symptoms such as cough, fever, heart rate and oxygen saturation, as well as other aspects of the results, to determine the next steps. And, while Revive, a Canadian biotech with a market cap of 21.6 million Canadian dollars ($16.1 million), is yet to see the data, it is optimistic that the molecule has a future.
According to Revive, the evaluation “could support further discussions with the FDA on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine a suitable regulatory pathway for approval of bucillamine.”
The biotech’s to-do list includes working with partners to pursue “international regulatory approvals and new clinical studies for long COVID or COVID symptom-related conditions and various infectious, inflammatory and respiratory disorders.”