· >60 patients have been randomized in the Company’s ~120-patient Phase 2 COVID-19 clinical trial
· With COVID-19 cases rising worldwide as the coronavirus continues to mutate, the need is greater than ever to develop novel broad spectrum antivirals of the future
WAKEFIELD, MA – April 28, 2021 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced that enrollment has surpassed 50 percent of the total targeted number of randomized trial participants (~n=120) in its double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897).
Brilacidin is the only non-peptidic defensin-mimetic drug candidate in the world currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19. Additionally, Brilacidin has shown potent inhibition in vitro against different strains of coronaviruses and alphaviruses (with lab testing against other virus families also underway), supporting Brilacidin’s potential to be developed as a broad spectrum antiviral.
“Achieving over 50 percent trial enrollment represents an important milestone as we advance Brilacidin for treatment of COVID-19,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We are hopeful Brilacidin will emerge not only as an effective COVID-19 therapeutic, but also as a desperately needed broad spectrum antiviral. With the world experiencing a record number of new COVID-19 cases, including nearly 1 million new infections in India across a 3-day period, we remain dedicated to bringing to market a novel antiviral to help ease patient suffering. We look forward to completing our COVID-19 clinical trial and releasing topline results.”
Linked below are recent articles published in the journal Nature. Both reinforce the need for developing novel antiviral drugs, such as Brilacidin, to help address the current COVID-19 crisis, as well as to be prepared to confront future pandemics.
· Funders, now is the time to invest big in COVID drugs (nature.com): Vaccine development has been a resounding success. But the medicine cabinet should have been better stocked.
· The race for antiviral drugs to beat COVID — and the next pandemic (nature.com): Despite dire warnings, a stockpile of ready compounds to fight viral pandemics was sorely lacking. Can drugmakers finally do the right thing?
About Brilacidin and COVID-19
Innovation Pharma is developing Brilacidin for COVID-19 under Fast Track designation from the U.S. Food and Drug Administration (FDA), and currently is enrolling patients in a Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Upon recently completing a scheduled review of interim safety data from the trial, an independent Data Monitoring Committee (DMC) recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, which may maximize therapeutic benefits and provide a comparison with 5-day remdesivir (Veklury™), currently the only FDA-approved treatment for COVID-19. The annual global antiviral drug market is estimated to reach $44 billion by 2026.
A peer-reviewed article in Viruses supporting Brilacidin’s COVID-19 treatment potential can be accessed at the link below.
· Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
https://www.mdpi.com/1999-4915/13/2/271