Innovation Pharmaceuticals Granted Regulatory Approval to Start Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Company Aims to Capture Large Market Opportunity for Novel Oral IBD Drug Candidates

BEVERLY, Mass., Dec. 13, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Company approval to start its Phase 1 trial to investigate the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers.

A total of nine subjects will be enrolled in the trial, three subjects per cohort. Each subject will receive one treatment at one assessment visit only. In each cohort, two subjects will receive Brilacidin, and one subject will receive placebo. An expedient clinical trial, dosing of all cohorts is expected to be completed within several weeks of commencement; top-line data are anticipated within a few weeks, thereafter.

The study is to be the first in a series of clinical trials, as part of the Company’s Ulcerative Colitis (UC) clinical program. The worldwide UC market was valued at $6.85 billion in 2018, with significant premiums being paid for novel oral Inflammatory Bowel Disease (IBD) treatments in development given shortcomings in current treatment regimens.

Objectives of the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation Phase 1 study of oral Brilacidin include:

• To visualize, using :
  
    º  the site of release of enteric coated delayed release tablets designed to target delivery of Brilacidin (50mg, 100mg, and 200mg) to the colon.
  
    º  the disintegration and dispersion of Brilacidin delayed release tablets in vivo.
• To evaluate the safety and tolerability of Brilacidin administered by delayed release tablet as single escalating doses.
• To assess systemic exposure/pharmacokinetics of Brilacidin following administration of delayed release tablets.

“It’s exciting to soon start, in collaboration with our IBD formulation partner, BDD Pharma, a scientifically-rigorous study of Brilacidin’s potential as a novel oral IBD drug candidate,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “There is a considerable market need for innovative non-corticosteroid and non-biologic IBD therapies, as which we believe Brilacidin, based on its unique drug properties and characteristics, is well-positioned to emerge. We already have established Brilacidin’s potential in treating Ulcerative Proctitis/Ulcerative Proctosigmoiditis, when delivered locally, leading to a licensing agreement signed with a global Pharma. A successful Phase 1 study of oral Brilacidin in healthy volunteers demonstrating our ability to target drug delivery would provide additional value to our shareholders as we continue to develop Brilacidin for IBD.”

About Brilacidin for IBD

Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 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 enema, 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 ()—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 (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

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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