Innovation Pharmaceuticals: Patient Screening for Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program On Track for Early January
Patient screening positions Company for completion of a short clinical trial
Significant market demand for oral drugs in Inflammatory Bowel Disease
Business development meetings scheduled during 2020 J.P. Morgan Healthcare Conference
BEVERLY, MA – December 26, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to announce that patient screening for its Phase 1 trial to investigate the use in healthy volunteers of delayed release tablets for colonic delivery of oral Brilacidin for treating Ulcerative Colitis, a chronic form of Inflammatory Bowel Disease (IBD), is expected to commence in early January.
Approximately two weeks ago, the United Kingdom’s Medicines and Healthcare products Regulatory Agency granted the Company approval to start the Phase 1 trial. Along with assessing the safety, toleration, and pharmacokinetics of oral Brilacidin, the study will evaluate the delivery of oral Brilacidin directly to the colon by utilizing advanced delayed-release drug delivery technology developed by the Company’s formulation partner.
“The study is expected to be a quick one, with dosing completed within several weeks of commencement, and, if successful, would translate into numerous potential positive outcomes for the company,” noted Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We are optimistic about the safety and efficacy profile of Brilacidin in IBD based on our prior clinical trial in Ulcerative Proctitis/Ulcerative Proctosigmoiditis, and are further encouraged that our out-licensing partner in this indication is planning to start trials mid year-2020. Now the key to differentiation and really catching the attention of big pharma for the opportunity is efficient delivery of the drug directly into the colon.”
Ehrlich continued: “Given the industry buzz around the recent IPOs of Galera Therapeutics and Monopar Therapeutics, each with late-stage drug candidates targeting Oral Mucositis, we feel confident about the competitive positioning and commercial prospects of oral rinse Brilacidin as a preventative OM drug candidate and the considerable value it can bring to our company. The investment community seems to be waking up to the large unmet need in this area. We anticipate an active partnering process, with meetings scheduled with pharmaceutical companies interested in Brilacidin-OM during the 2020 J.P. Morgan Healthcare conference this January in San Francisco. A licensing deal for the Brilacidin-OM asset would bring significant upside for our shareholders.”
In other news: The Company would like to inform shareholders that Arthur P. Bertolino, MD, PhD, MBA, has resigned from his positions as Director, and President and Chief Medical Officer. Dr. Bertolino and the Company have discussed the possibility for Dr. Bertolino continuing to serve as a consultant to the Company. The Company will begin interviewing new candidates for the position of Chief Medical Officer in January.
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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 disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. The Company plans to advance Brilacidin oral rinse into Phase 3 development, subject to available financial resources. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). Brilacidin for UP/UPS was licensed to Alfasigma S.p.A. in July 2019. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infection. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations and has successfully completed a Phase 2 trial in Ovarian Cancer. More information is available on the Company website at www.IPharmInc.com.
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 the future execution of a definitive agreement with a global pharmaceutical company and the anticipated terms thereof, our future drug development plans, 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, 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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