Innovation Pharmaceuticals Plans for Phase 2 Trial of New Treatment for Ulcerative Colitis
-- Active ulcerative colitis targeted; multiple ascending dose design (low, mid, high doses and placebo) -- Endpoints: clinical remission (Mayo scoring); endoscopic remission; biomarkers, and others
WAKEFIELD, Mass., March 05, 2020 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to provide perspectives on its planned Phase 2 clinical trial of Brilacidin in pill form, its defensin mimetic drug candidate with multi-indication potential, as a novel oral medication for the treatment of Ulcerative Colitis (UC).
The Company is presently interviewing Contract Research Organizations for site selection with the understanding that the goal is to initiate the trial this summer.
Following the completion of a Phase 1 study ( NCT04240223 ) that showed targeted colonic delivery of Brilacidin via the use of delayed-release formulated tablets, incorporated in the planned Phase 2 study design are elements highlighted below:
-- To assess efficacy and safety of oral Brilacidin in active UC across 6 weeks ° Part 1: Multiple Ascending Dose (MAD) design; low, mid, high doses and placebo Primary Purpose: to determine multiple dose safety/toleration and exposure in UC patients • Enriched PK collection will determine appropriate dose escalation to next cohort ° Part 2: Parallel Design; low, mid, high doses (selected from Part 1) and placebo Primary purpose to evaluate efficacy signal in UC patients • Efficacy Endpoints include: Clinical remission (Mayo Scoring); Endoscopic remission; Biomarkers (fecal calprotectin, CRP, histologic evaluation of mucosal inflammation); Patient Reported Outcomes (PROs)
Brilacidin is being developed in pill form as a novel, non-corticosteroid, non-biologic drug capable of treating a continuum of GI diseases, with UC the initial target indication.
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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.
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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