Antiviral Dosing Frequency Increased For Hospitalized COVID-19 Patients
Massachusetts-based Innovation Pharmaceuticals announced an independent Data Monitoring Committee (DMC) completed its interim safety data review 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.
Following their review of thirty patients, 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. Efficacy data was not reviewed by the DMC and remained blinded.
Recruitment for the 5-day treatment regimen has begun.
“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,” commented Leo Ehrlich, CEO at Innovation Pharmaceuticals, in a related press release.
“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.”
Innovation Pharma is developing Brilacidin under Fast Track designation from the U.S. Food and Drug Administration. Brilacidin is a Host Defense Protein mimetic representing a new class of drugs with antiviral, anti-inflammatory, and anti-bacterial properties.