Microba Life Sciences Limited announced that the first participants have been successfully dosed in the Phase I Clinical Trial of MAP 315, in Microba’s Therapeutic Program in Inflammatory Bowel Disease (IBD). This milestone brings Microba’s drug candidate MAP 315 into clinical development as a potential new treatment option for the millions of people suffering from ulcerative colitis. MAP 315, is a novel live biotherapeutic product being developed for the treatment of ulcerative colitis and was discovered and developed using Microba’s data-driven Therapeutics Platform. MAP 315, is a novel live biotherapeutic product being developed for the treatment of ulcerative colitis and was discovered and developed using Microba’s data-driven Therapeutics Platform.
Professor Trent Munro, SVP of Therapeutics at Microba said: “Microba has now matured into a clinical stage drug development company. I am proud of our team and what we have built to bring novel microbiome drugs all the way from human-data guided discovery, through to an orally delivered drug product now dosed in a first in human clinical trial. We are uniquely positioned at the forefront of drug development from the microbiome and excited about the future potential impact of MAP 315 as a new treatment for Inflammatory Bowel Disease sufferers.”
The Phase I clinical trial is a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of MAP 315 in 32 healthy adults. The trial is being conducted by Nucleus Network in Melbourne, Australia, under the Company’s Human Research Ethics Committee (HREC) approval and in alignment with formal feedback received from an FDA pre-IND engagement.
MAP 315 Phase 1 Clinical Trial Details
The clinical trial is titled “A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MAP 315 in Healthy Adults”. The study will enroll 2 cohorts of 16 participants each, who will be randomised 3:1 to receive MAP 315 or its matching placebo for 14 consecutive days (2 weeks). Results from the trial are expected to be available in December 2023. Full study details can also be found in the Australian New Zealand Clinical Trials Registry (ANZCTR) under study ID: ACTRN12623000291684.
Microba’s Novel Drug Candidate MAP 315
MAP 315 was identified using Microba’s unique analysis of its large proprietary human databank, demonstrating that this previously uncharacterised and novel bacterial species is commonly observed in healthy individuals but consistently deficient in individuals with IBD. Subsequent pre-clinical investigation of MAP 315 through both in vitro and in vivo models demonstrated that MAP 315 promotes epithelial restitution and mucosal healing – biological activities that are critical for sustained disease remission but not adequately addressed through existing therapy.
MAP 315 is a live biotherapeutic product (LBP) consisting of lyophilised bacteria in an enteric coated capsule which is orally administered and being developed as an investigational product for the treatment of ulcerative colitis (UC). Microba worked in partnership with leading microbiome contract drug manufacturer Bacthera to produce GMP compliant MAP 315 at large-scale in their state-of-the-art facilities in Europe to supply material for the MAP 315 clinical trial.