Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, announced today that the Company has received agreement from the study’s Dose Escalation Committee (DEC) to progress dosing to the third and final cohort in its Phase 1 trial to investigate the use of delayed release tablets for colonic delivery of Brilacidin in healthy volunteers.
Following dose escalation of oral Brilacidin from the first cohort (50mg) to the second cohort (100mg), safety findings from the second cohort similarly were reviewed by the DEC. The Principal Medical Investigator and Sponsor agreed it acceptable to increase the dose of Brilacidin for administration to a third and final cohort (200mg), per trial design.
In this Phase 1 clinical trial, nine subjects will be enrolled in the single-center, randomized, single-blinded, placebo-controlled, single dose-escalation trial, three subjects per cohort. In each cohort, two subjects will receive Brilacidin (cohort 1: 50mg; cohort 2: 100mg; and cohort 3: 200mg) and one subject will receive placebo. Assessments will include the safety, toleration, and pharmacokinetics of oral Brilacidin, and whether the drug is being dispersed directly in the colon through the use of delayed release tablets, as assessed by gamma scintigraphy.
Shareholder Alert: Innovation Pharmaceuticals Announces Dose Escalation for Final Cohort