Innovation Pharmaceuticals Provides Update on COVID-19 Clinical Trial, Compassionate Use Requests and Research into Brilacidin's Broad-Spectrum Antiviral Properties
WAKEFIELD, MA / ACCESSWIRE / September 23, 2021 / Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today provided an update on the status of its randomized, double-blind, placebo-controlled Phase 2 clinical trial of Brilacidin for the treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897), as well as related news.
Based on information received from the data management and biostatistics vendors, study unblinding, analysis of the unblinded data and release of topline study results for the Brilacidin COVID-19 trial is anticipated to occur in mid-to-late October. The Company looks forward to the data to learn if Brilacidin's multiple properties translate into meaningful clinical results, given the unmet need for COVID-19 therapeutics and ongoing pandemic.
In related news, the Company has received individual patient Expanded Access (compassionate use) requests for Brilacidin to treat critically ill COVID-19 patients who are not responding to prior therapy. Expanded Access was implemented by the FDA and Congress to address physician applications for access to potentially lifesaving drugs, prior to FDA approval, for patients in their care when available treatment options have failed. Following receipt of such requests, the Company has supplied Brilacidin to relevant hospitals for individual patient use, with the FDA granting the treating physician permission for the emergency administration of Brilacidin. In addition to Brilacidin's antiviral profile, Brilacidin's immunomodulatory and anti-inflammatory properties may be particularly beneficial in treating COVID-19 in hospitalized patients.
For more details on the Company's Expanded Access policy, please visit:
Brilacidin in vitro antiviral research remains ongoing at multiple universities. New preliminary data from one academic laboratory show Brilacidin is active against adenoviruses--a non-enveloped virus--complementing earlier data showing potent Brilacidin inhibition of different strains of coronaviruses, alphaviruses and bunyaviruses (enveloped viruses). A paper from this lab on Brilacidin's broad-spectrum antiviral effect in multiple virus families is being prepared. Separate scientific papers also are underway from two other academic research groups supporting Brilacidin's antiviral properties and providing insight into Brilacidin's mechanisms of action.
About Brilacidin and COVID-19
Brilacidin is the only non-peptidic defensin-mimetic drug candidate currently in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19 (see NCT04784897). Innovation Pharmaceuticals is developing Brilacidin for the treatment of COVID-19 under U.S. FDA Fast Track designation. A dual-acting inhibitor able to target viral proteins and host factors, while also exhibiting robust anti-inflammatory and antibacterial properties, Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses, bunyaviruses and adenoviruses (with lab testing against other viruses also underway), supporting Brilacidin's development as a broad-spectrum antiviral. 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
Two independent Machine Learning studies identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin's molecular properties. Click here to learn more.
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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 statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other viruses, as well as obtaining government regulatory approvals to commence clinical testing. Other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, 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 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; the fact that the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or the fact 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. A more complete description of these risk factors is included in the Company's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. 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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