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.