Revive Therapeutics has rethought its strategy after seeing data from its failed phase 3 COVID-19 trial. After initially outlining plans to push ahead in the respiratory disease, the biotech is now increasing its focus on other indications.
Toronto-based Revive revealed the termination of a phase 3 clinical trial of its antirheumatic molecule bucillamine in patients with mild to moderate COVID-19 in May. The biotech pulled the plug on the study on the recommendation of the independent data safety monitoring committee, which concluded it was on course to fail based on an interim look at the results.
At the time, Revive’s to-do list included discussions with the FDA and potential pharma partners about bringing the drug candidate to market in COVID-19. Now, after seeing the data, the biotech has released a revised list of priorities.
Revive has bumped the reformulation of bucillamine up to the top of its to-do list. The biotech outlined reformulation plans in its earlier release but has now expanded on its view that intravenous and inhaled formulations can unlock the use of bucillamine in acute respiratory distress syndrome and as a medical countermeasure against biological, chemical and nuclear attacks.
The other two strategic goals are to form pharma partnerships and to secure government support. Revive is now interested in partnerships covering infectious, inflammatory and respiratory disorders. The biotech has removed the reference to long COVID or COVID symptom-related conditions that it made in its prior list of activities.
Revive revised its plans after reviewing the results of the COVID-19 trial, which was blinded when it put out its statement in May. In the latest statement, Revive revealed that in the 28 days after randomization, there were three hospitalizations in the placebo arm and one hospitalization in patients on bucillamine. The one bucillamine hospitalization was in the lower-dose arm that was stopped at an interim analysis.
While hospitalization trends favored bucillamine, “the estimated chance of hitting statistical significance after study enrollment completion and final analysis was only 5.48%,” Revive said. Bucillamine did no better than placebo across secondary endpoints that looked at clinical symptoms and viral load.