BEVERLY, MA – July 13, 2017 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces that a majority of patients treated with Brilacidin achieved Clinical Remission 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 formulation development plans including oral tablets for the treatment of Ulcerative Colitis and Crohn’s Disease and foam and/or gel for the treatment of UP/UPS.
Results
Using Modified Mayo scoring, the study’s Primary Efficacy Endpoint of Clinical Remission at Day 42 (Week 6) was defined as: (i) an Endoscopy subscore ≤ 1; (ii) Rectal Bleeding subscore of 0; and (iii) improvement or no change from baseline in the Stool Frequency subscore.
Topline results, which include additional detailed review of patient data in Cohort A and Cohort B following interim analysis, showed favorable Clinical Remission rates that were similar across cohorts.
Rate of Clinical Remission (% of patients achieving)
· 60% Cohort A (3 of 5 patients)*
· 67% Cohort B (4 of 6 patients)
· 75% Cohort C (3 of 4 patients)*
(*Among the 17 patients enrolled in the trial, one patient from Cohort A and one patient from Cohort C declined endoscopy at Day 42 and thus were not included in the analysis population of those achieving Clinical Remission, i.e., the total number of evaluable patients was 15.)
The percentage of evaluable patients (n=15) meeting individual component criterion of Clinical Remission was also favorable, with rates similar across cohorts:
(i) #Endoscopy subscore ≤ 1 (% of patients achieving)
· 80% Cohort A (4 of 5 patients)
· 67% Cohort B (4 of 6 patients)
· 75% Cohort C (3 of 4 patients)
(#Note: Investigator assessment of rectal and sigmoid mucosa up to 40 cm from anal verge.)
(ii) Rectal Bleeding subscore of 0 (% of patients achieving)
· 80% Cohort A (4 of 5 patients)
· 100% Cohort B (6 of 6 patients)
· 100% Cohort C (4 of 4 patients)
(iii) Stool Frequency subscore, improvement or no change from baseline (% of patients achieving)
· 100% Cohort A (5 of 5 patients)
· 100% Cohort B (6 of 6 patients)
· 100% Cohort C (4 of 4 patients)
Improvement in Quality-of-Life, using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), was reported with more than 60 percent of patients in each cohort achieving a ≥10-point or more improvement after six weeks of treatment. At least half of patients in Cohorts B and C also showed ≥20-point or more improvement.
Brilacidin for UP/UPS also was shown to be generally well-tolerated, with no Serious Adverse Events (SAEs) experienced by patients, which is consistent with the low levels of systemic absorption of Brilacidin observed in the trial.
The Company has presented detailed topline results from the Brilacidin-UP/UPS trial, as well as information on the ongoing Brilacidin Phase 2 trial in the treatment of Oral Mucositis, at the Drug Discovery & Therapy World Congress in Boston, MA, held today. A corresponding slide deck is now posted to the Company’s website at the link below:
Comments
“As a practicing gastroenterologist, it’s extremely exciting to see Brilacidin’s emergence as a possible novel treatment for Inflammatory Bowel Disease. Brilacidin’s unique mechanism of action and compelling clinical trial results support its potential,” said Francis A. Farraye, MD, MSc, Clinical Director, Section of Gastroenterology at Boston Medical Center, Professor of Medicine at Boston University School of Medicine and Scientific Advisor to Innovation Pharmaceuticals. “There exists a large unmet medical need in treating patients with Inflammatory Bowel Disease given its complex pathogenesis and high degree of variability in how patients respond to a given treatment. I look forward to continuing to work closely with the Innovation Pharmaceuticals team as they advance Brilacidin in the treatment of IBD.”
Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals, commented: “We are incredibly pleased with the successful completion of this trial and the dataset that we now have in-hand. To see such strong results with a basic formulation adds further credibility to where we believe we can take Brilacidin in treating the full continuum of IBD, particularly when optimally formulated and administered. Combined with the Brilacidin data for treating Oral Mucositis as a preventative medicine, we now have two solid anchors supporting Brilacidin’s considerable and diverse therapeutic potential.”
Study Overview
In this 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).