BEVERLY, MA – June 26, 2017 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that patient treatment has been completed in its Phase 2 open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment.
With the study treatments now completed, Brilacidin has consistently shown strong signs of efficacy while exhibiting a good safety profile even as dosing increased, supporting its potential as a novel, non-corticosteroid, non-biologic anti-inflammatory drug candidate in treating IBD. Innovation Pharmaceuticals’ formulation development plans for Brilacidin include foam and/or gel for the treatment of UP/UPS, and pills for oral dosing for the treatment of Ulcerative Colitis and Crohn’s Disease.
“For those of us who have been involved in this trial from the start, it’s exciting to see Brilacidin perform as well as we thought it would. The endoscopic evidence we have now gathered on patients is particularly telling,” commented Arthur P. Bertolino, MD, PHD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Brilacidin’s unique multi-pronged ability to reduce inflammation, fight infection and heal GI tract mucosa has been impressive, based both on subjective and objective scoring measures. It’s no surprise to us why we’ve generated significant excitement regarding Brilacidin among patients, health care professionals and potential industry partners interested in this truly novel IBD drug candidate. We look forward to sharing the Brilacidin UP/UPS data in early July.”
The Company will be presenting topline results across all cohorts from the Brilacidin-UP/UPS trial at the Drug Discovery & Therapy World Congress in Boston, MA, to be held on July 13, 2017.
Program details are available at:
For reference, previously released detailed interim findings from the Brilacidin UP/UPS trial are available at the following link:
In the Phase 2 PoC trial, a total of 17 patients received treatment across three sequential, dose-escalated cohorts—Cohort A (6 patients); Cohort B (6 patients); and Cohort C (5 patients). Patients received Brilacidin, once daily, at 50 milligrams (mg), 100 mg and 200 mg, respectively, administered per rectum as a retention enema for 42 days (6 weeks) of treatment. The Primary Efficacy Endpoint of the Brilacidin UP/UPS trial used Modified Mayo Disease Activity Index (MMDAI) scoring, a common measurement tool in managing Ulcerative Colitis preferred by many IBD specialists, to determine Clinical Remission at Day 42. Secondary Efficacy Endpoints included: change in MMDAI score, both Full and Partial, and; change in patient Quality of Life as assessed by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ).