Innovation Pharmaceuticals announced that an independent Data Monitoring Committee (DMC) completed its scheduled review of interim safety data in the Company’s randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897).
Upon reaching 25 percent enrollment (30 subjects), recruitment was paused and a pre-specified unblinded safety data review and evaluation was conducted by the DMC. Following their review, the DMC recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, as intended per the protocol, which the Company has since implemented. Recruitment for the 5-day treatment regimen has begun. Efficacy data was not reviewed by the DMC and remains blinded.
“We are thrilled with the recommendation of the DMC pertaining to the safety profile of Brilacidin, a drug that has repeatedly been shown in lab studies by virology experts as a top candidate for fighting infectious and resilient coronaviruses, including SARS-CoV-2, the pathogen responsible for COVID-19,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “There is a sense of urgency to develop novel pan-coronavirus therapeutics for COVID-19, particularly given the growing spread of variants worldwide, including P1 and B.1.1.7, which appear to be contributing to cases of infection cropping up in patients who have already been vaccinated. With its unique mechanism of action to directly disrupt the novel coronavirus, we believe Brilacidin possesses potential to address these worrisome reminders that SARS-CoV-2 isn’t going anywhere. More broadly, Brilacidin’s antiviral potency also appears to extend beyond coronaviruses to other types of viruses, based on independent ongoing laboratory research, further supporting Brilacidin’s broad spectrum antiviral potential.”
The clinical rationale for consideration of expanding treatment duration to 5 days, from the initial dosing regimen of 3 days, is to provide a longer duration of systemic Brilacidin exposure at a level that can strongly suppress SARS-CoV-2 virus replication, and associated symptoms, and thus maximize therapeutic benefits to hospitalized patients with moderate or severe COVID-19. The expanded dosing regimen has particular value in that a 5-day dosing is the recommended initial treatment duration for Gilead Sciences’ Veklury® (remdesivir), the only FDA-approved antiviral drug for treatment of COVID-19. Trial data for Veklury could serve as a benchmark in evaluating Brilacidin outcomes.
The Company aims to expedite enrollment in the coming weeks toward study completion and release of topline results. Two sites, in addition to the 9 currently active and recruiting patients, have been initiated, with a further two sites planned to initiate within the next week.
Innovation Pharma is developing Brilacidin, a defensin-mimetic, under Fast Track designation from the U.S. Food and Drug Administration (FDA).