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.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious diseases, and dermatologic diseases.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including, without limitation, statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its potential impact on SARS-CoV-2 (COVID-19) and other viruses. Other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company's actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation that the Company's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere; prior test results may not be replicated in future studies and trials; the Company's need for, and the availability of, substantial capital in the future to fund its operations and research and development, including the amount and timing of the sale of shares of common stock under securities purchase agreements; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and the Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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