Microba Life Sciences Limited (ASX: MAP) has appointed Beyond Drug Development as the lead Contract Research Organisation (CRO) for its upcoming Phase 1 trial of novel microbial cell therapy, MAP 315, for the treatment of Ulcerative Colitis, the most prevalent form of Inflammatory Bowel Disease (IBD).
The lead candidate for the MAP 315 program was discovered using Microba’s human-first, data-driven Therapeutic Platform, and has demonstrated strong efficacy and an excellent safety profile in pre-clinical development.
Beyond Drug Development, based in Brisbane, Australia, is a CRO with a special focus on product development and early phase research. Beyond will bring extensive industry experience to the MAP 315 study, through its expert team (averaging 20 years’ experience) and continuously growing reputation in serving biotech companies like Microba, as well as established pharmaceutical companies.
In addition to this partnership with Beyond Drug Development, Microba have selected Nucleus Network as the preferred clinical trial site. Located within cutting-edge health precincts, Nucleus Network provides accelerated clinical development solutions supported by advanced technology, clinical excellence and research expertise.
“This is a significant step forward for Microba as we accelerate our MAP 315 program into clinical trials. We look forward to this partnership with Beyond Drug Development and Nucleus Network for this Phase 1 study.”Prof. Trent Munro, SVP of Therapeutics at Microba
The MAP 315 Phase 1 study is scheduled for commencement in late 2022.
The study will be conducted as a Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MAP 315 in Healthy Adults. This study will form the basis for rapidly transitioning into a Phase 2 efficacy study in Ulcerative Colitis patients.
cGMP manufacturing is on track with Microba’s manufacturing partner Bacthera in Switzerland to deliver clinical doses of MAP 315 for the trial.