Microba commences phase 1 clinical trial for IBD drug
Australian precision microbiome company Microba has announced that the first participants in its phase 1 inflammatory bowel disease (IBD) clinical trial have been successfully dosed with its lead therapeutic programme MAP 315.
MAP 315 is a live biotherapeutic product (LBP) made of lyophilised bacteria in an enteric coated capsule. It was identified using an analysis of human samples that highlighted previously uncharacterised and novel bacterial species which were commonly observed in healthy individuals but deficient in patients with IBD. In vivo and in vitro studies of MAP 315 demonstrated that it promoted epithelial restitution and mucosal healing ‒ crucial biological activities to achieving sustained disease remission. MAP 315 is orally administered and being developed for the treatment ulcerative colitis (UC), one of the two major forms of IBD.
The phase 1, randomised, double-blind, placebo-controlled study will enrol two cohorts of 16 participants each who will be randomised to receive MAP 315 or a placebo for 14 consecutive days. The study aims to evaluate the safety, tolerability and pharmacokinetics of MAP 315 in healthy adults. Results are expected in December 2023.
Professor Trent Munro, senior vice president of TherapeuticsatMicroba, 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 IBD sufferers.”
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