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Innovation Pharmaceuticals Phase 2 PoC Trial for Inflammatory Bowel Disease Achieves Induction of Remission in a Majority of Patients Treated with Brilacidin
Innovation Pharmaceuticals Phase 2 PoC Trial for Inflammatory Bowel Disease Achieves Induction of Remission in a Majority of Patients Treated with Brilacidin.
About this update from Innovation Pharmaceuticals Inc.
[{"type":"text","content":"\n\n BEVERLY, Mass., 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).\n 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...