Australian company Microba Life Sciences (ASX:MAP) has announced that the first participants have been successfully dosed in a phase 1 clinical trial of its candidate for inflammatory bowel disease (IDB).
The company said its MAP 315 was identified using its large proprietary human databank.
It said the analysis demonstrated that this previously uncharacterised and novel bacterial species is commonly observed in healthy individuals but consistently deficient in people with IBD.
According to Professor Trent Munro, Microba's senior vice president of therapeutics, “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.
The company said it will enrol two cohorts of 16 participants, who will be randomised 3:1 to receive MAP 315 or its matching placebo for 14 consecutive days. Results from the trial are expected to be available in December 2023.