Brilacidin utilizing new delayed release technology for targeted delivery directly to colon
WAKEFIELD, MA – January 24, 2020 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today the Company completed dosing in the third and final cohort in the Phase 1 trial investigating the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers.
Topline data is expected shortly and includes the safety, tolerability and pharmacokinetics of the Brilacidin tablets. Importantly, the results also include an assessment of the delivery of Brilacidin directly to the colon as determined through gamma scintigraphy.
The Company has partnered with BDD Pharma to utilize their proprietary OralogiK™ technology, an unrivalled erosion-based technology that controls the release of the drug at a pre-defined time. Additional information on this leading technology can be found on the BDD Pharma website.
In the Phase 1 clinical trial, nine subjects were enrolled in the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation trial, three subjects per cohort. In each cohort, two subjects received Brilacidin (cohort 1: 50mg; cohort 2: 100mg; and cohort 3: 200mg) and one subject placebo.
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.