Innovation Pharmaceuticals Announces Dosing of First Cohort in Phase 1 Trial of Oral Brilacidin in Ulcerative Colitis Program; Topline Results Anticipated Early Q1 2020
WAKEFIELD, MA – January 16, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders that the Company has dosed the first cohort in its Phase 1 trial to investigate the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers. This study formally launches the Company’s clinical program in Ulcerative Colitis.
Assessments will include the safety, toleration, and pharmacokinetics of oral Brilacidin, and whether the drug is being dispersed directly in the colon, as assessed by gamma scintigraphy. Dosing of all cohorts in the Phase 1 trial is expected to be completed within several weeks, and topline data to follow shortly.
The start of this Phase 1 trial is a major milestone for the Company, a key part of its broader clinical program in Inflammatory Bowel Diseases (IBD). The study’s primary objective is to show that Brilacidin can be delivered orally and selectively to the colon. This will enable the Company to treat more extensive forms of GI disease, primarily Ulcerative Colitis and Crohn’s Disease.
Notably, in other clinical trials, Brilacidin has been shown to be a promising drug candidate in multiple therapeutic areas and across various modes of administration. In a previous Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring). Evidence of mucosal healing was supported based on endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. These trial results led to the licensing of Brilacidin for UP/UPS to a global pharmaceutical company.
If later trial results in the Ulcerative Colitis program are similarly as successful to those achieved in the completed UP/UPS study, the Company believes oral Brilacidin’s therapeutic potential and licensing opportunities will be significant. Big Pharma is willing to pay a premium for novel oral clinical assets in development for IBD, based on strong patient preference for easily-administered oral drugs and other economic advantages of oral delivery compared to costly and burdensome IBD treatments delivered via injection and IV infusion.
In this clinical trial, nine subjects will be enrolled in the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation trial, three subjects per cohort. In each cohort, two subjects will receive Brilacidin (cohort 1: 50mg; cohort 2: 100mg; and cohort 3: 200mg) and one subject will receive placebo.
The Company will keep shareholders updated as it works to complete this short Phase 1 trial.
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 (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 (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.
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