Innovation Pharmaceuticals Announces Clinical Development Plans for Oral Brilacidin for Inflammatory Bowel Disease
BEVERLY, MA – January 22, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to announce plans to initiate in 2019 a clinical trial of Brilacidin, its novel defensin-mimetic drug candidate, as an oral dosage form. Building upon the successful Phase 2 Proof-of-Concept (PoC) clinical trial for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), the aim of this program is to develop treatment for the more extensive forms of Inflammatory Bowel Disease (IBD), such as Ulcerative Colitis and Crohn’s Disease.
In the Phase 2 PoC trial, Brilacidin administered as a retention enema for treating UP/UPS demonstrated a clinically meaningful improvement with more than 50 percent of patients experiencing clinical remission of disease at day 42. Additional clinical measures supported the therapeutic benefit of Brilacidin, including rectal bleeding eliminated in 16 of 17 patients at day 42 and 16 of 17 patients reporting improved quality of life per Short IBD Questionnaire. Furthermore, Brilacidin showed a favorable safety profile with no serious adverse events reported and the therapy well-tolerated by patients.
The planned oral Brilacidin clinical trial builds on recently released data showing in simulated gastric fluid testing very minimal degradation of Brilacidin across 4 hours, suggesting Brilacidin likely would not be subject to rapid breakdown once in the stomach. These, and other data, are informing necessary manufacturing next steps—including soliciting Requests-for-Proposals from vendors—toward developing an elegant, tailored oral dosage form of Brilacidin. As a first step, a simple oral formulation of Brilacidin, may be expediently tested in human volunteers, while the refined oral dosage form of Brilacidin is developed in parallel. The anticipated clinical study’s primary goals include assessing safety and toleration, pharmacokinetics, and the effects of Brilacidin on the gut’s microbiome.
“We’re extremely excited to continue to advance our oral Brilacidin IBD program,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “IBD represents a large therapeutic area, affecting millions of people worldwide, in which novel, non-biologic, oral therapies are desperately needed. Approximately one-third of patients fail to respond to initial current IBD treatments, with another one-third of patients developing a loss-of-response within a few months of going on drug. We look forward to updating shareholders on oral Brilacidin formulation work and the design of our next planned IBD program study.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 5 million people worldwide, including 1 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: 1) its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and 2) its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.
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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. 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 Infections. 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 projected timelines for the initiation and completion of clinical trials, including planned Phase 3 trials of Brilacidin, 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 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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