Microba Life Sciences (ASX:MAP) has announced initial unblinded data from the Phase 1 clinical trial of lead drug candidate MAP 315 in the company’s Inflammatory Bowel Disease (IBD) Therapeutic Program.
The company said the results demonstrate a strong safety and tolerability profile for MAP 315 and support the continued clinical development of the lead drug candidate, which is being studied for the treatment of ulcerative colitis.
According to the company, MAP 315 had a favourable safety and tolerability profile across low and high-dose cohorts. There were no clinically significant safety signals from safety assessments and no evidence of translocation of MAP 315 into the bloodstream.
The company said, “Recent preclinical characterisation data, together with these Phase 1 clinical study results provide strong positive support for continuing to advance the clinical development of MAP 315 for the treatment of Ulcerative Colitis. Data from the trial is expected to be formulated and submitted for peer-review publication.”
Professor Trent Munro, senior vice president of Therapeutics at Microba, said, “We are very pleased with the results from this clinical study, which provide the foundation for further clinical development of MAP 315 in patients with Ulcerative Colitis. Microbiome based live biotherapeutics have the potential to be a revolutionary new therapeutic modality and this is exemplified by the observed safety profile in this study.”
