Innovation Pharmaceuticals Announces Topline Results from Phase 2 Clinical Trial of Brilacidin for COVID-19

WAKEFIELD, MA / ACCESSWIRE / November 11, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today reported topline results from the Company's Phase 2 clinical trial of Brilacidin in hospitalized patients with moderate-to-severe COVID-19. Brilacidin is being developed for treatment of COVID-19 under FDA Fast Track designation.

Brilacidin did not show a difference compared to placebo in reducing Time to Sustained Recovery Through Day 29, the study's primary endpoint based on clinical status. Clinical status endpoints contain a degree of subjectivity that may impact outcomes of COVID-19 trials. Additional analysis of topline and all study endpoints is ongoing.

"Though disappointed with these topline results, treating moderate-to-severe COVID-19 is an exceptionally difficult patient population," said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Companies, such as Merck and Regeneron, also did not show clinical benefit in these groups of patients, although both went on to refocus their development efforts in mild-to-moderate COVID-19 and achieve success. Regarding our Brilacidin antiviral program in general, collaborations with NIH scientists and academic researchers to explore Brilacidin's broad-spectrum antiviral activity in different viruses are ongoing. Initial feasibility work to formulate Brilacidin for potential prophylactic use via inhaled delivery, to leverage Brilacidin's unique virucidal and blocking antiviral properties, also is underway. There are many paths to pursue in the antiviral space. We believe Brilacidin holds tremendous promise as a differentiated antiviral drug candidate and plan to continue its development in this area of great opportunity and unmet need."

Topline safety data showed Brilacidin was generally well-tolerated, with frequency of treatment-emergent adverse events similar between study arms. The number of patients who died totaled eight, four each between active and placebo. The overall mortality rate (6.67%) in the trial was approximately one-half of what is typically observed in this patient population.

The randomized, double-blind, placebo-controlled trial (see NCT04784897) evaluated the efficacy and safety of intravenous Brilacidin administered for 3 or 5 days in addition to standard of care. In the trial, 120 patients were treated, with three-fourths receiving 5 days of study drug. Patients were evenly split between male and female, with a majority categorized as experiencing severe COVID-19 at baseline. Most patients were under 65 years old, with an average age of 58.