Innovation Pharmaceuticals Analyzing Full Dataset for Its Brilacidin COVID-19 Clinical Trial; Company Evaluating New Pipeline Opportunities for 2022
WAKEFIELD, MA / ACCESSWIRE / December 7, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today provides shareholders with perspectives on the Company's go-forward strategy heading into 2022.
The Company is pleased to report that as of last week it had received all unblinded data/data outputs from the recently completed Phase 2 clinical trial of Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients. The Innovation team is working with biostatistics partners to explore the data-conducting deeper analysis of different subgroups by patient demographics and baseline characteristics, domestic versus overseas COVID-19 standards of care, and more-to potentially identify meaningful patterns and positive trends. Analysis of the compassionate use of Brilacidin in the U.S. in critically-ill COVID-19 patients who had exhausted all other therapeutic options also is planned. Changes to biomarkers and positive clinical changes were observed, with some compassionate use patients administered Brilacidin more frequently and over a longer duration than patients in the Phase 2 Brilacidin COVID-19 trial. Collectively, these actions will help inform next steps for Brilacidin against COVID-19 in the coming year, while Brilacidin's broad-spectrum antiviral properties continue to be researched through NIH and other scientific collaborations.
As discussed previously, the Company remains focused on developing Brilacidin as a novel therapy for Inflammatory Bowel Disease (IBD), specifically Ulcerative Colitis, and also has plans to initiate Phase 3 testing of Brilacidin as an oral rinse treatment for Oral Mucositis (OM) in head and neck cancer patients. Drug product development is ongoing with specialized Contract Development and Manufacturing Organizations (CDMOs) responsible for refining the respective Brilacidin formulation. The IBD and OM clinical indications represent large areas of unmet need, with significant addressable commercial markets.
Elsewhere, Innovation management is engaged in discussions potentially to acquire rights to new pipeline assets, as well as to enter into new licensing agreements. The Company plans to provide updates on these matters as warranted. There is no guarantee, implied or otherwise, that such matters will result in the execution of definitive agreements.
"We were surprised when we learned the topline results of our Phase 2 Brilacidin COVID-19 clinical study. Many factors contributed to our expectations for a successful trial, including compelling in vitro results against SARS-CoV-2, even while we remained pragmatic. Just about all other Pharmas, both large and small, have struggled to show clinical benefit in treating hospitalized COVID-19 patients," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Among critically-ill patients who received Brilacidin under compassionate use in an open label manner, we were told noticeable improvements were seen in key inflammatory biomarkers shortly after receiving Brilacidin treatment. Subsequent positive changes to patient clinical status were also observed. We plan to review these data further, alongside performing subgroup analysis for our Phase 2 COVID-19 trial, as it will help inform our efforts against COVID-19."
Ehrlich added, "The Company is moving ahead with a strategic focus. Efforts are underway to advance Brilacidin's clinical development on multiple fronts, as well as to explore potential new pipeline additions that could be transformational for our company in 2022."
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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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