Innovation Pharmaceuticals Provides Brilacidin Program Update
Innovation Pharmaceuticals (OTCQB:IPIX) provided an update on Brilacidin, its investigational drug for multiple indications. While the Phase 2 COVID-19 clinical trial did not meet its primary endpoint, further data analysis is underway to explore potential applications, including government-sponsored trials. Compassionate use cases show promise, particularly with extended dosing. The company continues to focus on Brilacidin's potential for Ulcerative Colitis and Oral Mucositis. Plans for clinical testing of Brilacidin in these indications and ongoing research are highlighted as key developments.
- Further analysis of Phase 2 COVID-19 trial data may reveal additional insights for Brilacidin.
- Compassionate use data shows potential for improved outcomes with extended dosing in critically ill patients.
- Brilacidin development for Ulcerative Colitis and Oral Mucositis addresses large unmet medical needs.
- Brilacidin Phase 2 COVID-19 trial failed to meet its primary endpoint.
WAKEFIELD, MA / ACCESSWIRE / November 18, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today provided an update on clinical development plans for Brilacidin, the Company's defensin-mimetic drug candidate being evaluated in clinical testing for multiple indications.
The Company remains optimistic about Brilacidin even though the Brilacidin Phase 2 COVID-19 clinical trial did not meet its primary endpoint. There is much still to learn from the trial, with full analysis of the data ongoing. Should deeper analysis yield promising data, the plan is to submit Brilacidin for inclusion in government-sponsored COVID-19 clinical trial platforms.
The Company is further encouraged by compassionate use of Brilacidin, which involved the treatment of extremely critically-ill patients who had exhausted all other therapeutic options. Compassionate use cases comprised Brilacidin being administered over a longer duration (up to 10 days) than in the Phase 2 COVID-19 trial (3 and 5 day dosing), with some patients also receiving higher and more frequent dosing (two doses every 24 hours). Patient data is planned to be compiled and evaluated, which may shed additional light on Brilacidin's treatment potential in COVID-19.
More broadly, evaluation of Brilacidin's broad-spectrum antiviral properties continues through collaborations with NIH scientists and academic researchers, and may introduce opportunities to study Brilacidin in neglected tropical diseases. The Company plans to announce new findings as they are reported to us.
The Company also has not lost sight of the fact that, while Brilacidin for COVID-19 moved to the forefront due to the global pandemic, the focus pre-COVID was on developing Brilacidin for Ulcerative Colitis and Oral Mucositis, both areas of large unmet need with substantial commercial opportunities.
New Inflammatory Bowel Disease (IBD) treatments are sought after given IBD's complex pathogenesis and variability in patient response to any one drug. Oral delivery of Brilacidin to the gut is focused on developing an immediate release, multi-particulate capsule formulation in preparation for clinical testing of Brilacidin in Ulcerative Colitis. Research on Brilacidin stability in the GI tract and its interaction with the gut's microbiome also is underway. Oral Mucositis (OM), a painful side-effect of chemoradiation, similarly represents a tremendous unmet need, as there are no approved drugs for prevention of severe OM. The OM competitive landscape has changed significantly, the result of recent later-stage clinical trial failures by Oragenics, Soligenix and Galera. Development of an optimized Brilacidin oral rinse formulation is in progress, with potential to progress to Phase 3 OM testing in 2022.
The Company believes strongly in Brilacidin's treatment potential and its commercial prospects as a novel drug candidate proven to have antibiotic, anti-inflammatory and antiviral properties. We remain committed to the advancement of our pipeline on multiple fronts and will provide additional updates on pre-clinical and clinical developments as they occur.
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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.
INVESTOR AND MEDIA CONTACTS
Innovation Pharmaceuticals Inc.
Leo Ehrlich
info@ipharminc.com
SOURCE: Innovation Pharmaceuticals Inc.
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