Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) has made a key protocol amendment for its COVID-19 drug trial and in its plans to submit a Type C meeting request with the Federal Drug Administration (FDA), according to analysts at Leede Jones Gable.
Revive aims to test its oral cysteine derivative drug Bucillamine in a planned Phase 3 trial in patients with mild-to-moderate COVID-19. The FDA required the specialty life sciences company to provide additional information in order to proceed with a revised primary endpoint for the trial, the analysts wrote in a report.
That endpoint is the difference in proportion of patients with improvement of at least two COVID-19 related clinical symptoms at or before a two-week follow-up, compared to baseline, according to the analysts.
READ: Revive Therapeutics finalizes amended Phase 3 COVID-19 study protocol for FDA submission
If the revised protocol is approved, the US Data Safety Monitoring board (DSMB) will then review post-dose selection data from about 500 patients with regards to the revised endpoint, they wrote.
If there is a trend towards achieving statistical significance, the DSMB will either recommend the trial proceed, or halt the trial early pending positive efficacy showing statistical significance, or if statistical significance is not met, the analysts said.
Shortly announcing the amended protocol, Ontario-based Revive said it plans to submit a request to the FDA for a Type C meeting by mid-December of this year.
“We stand by our view that buccillamin’s thiol-reactive chemistry could be relevant for mitigating binding of COVID-19’s surface/spike protein to the ACE2 receptor in lung epithelium and pre-clinical data shows that this inhibition can indeed transpire in vitro,” the analysts noted.
Mode of administration – systemic administration via oral dosing versus inhalable formulations delivered directly to lung alveoli – could be a line of investigation in future bucillamine anti-viral testing, according to Leede Jones Gable analysts.
Contact the author at susie@proactiveinvestors.com