Microba Life Sciences Limited announced that it has received formal Human Research Ethics Committee (HREC) approval for its upcoming Phase 1 clinical trial of novel drug candidate MAP 315. MAP 315 is a novel live biotherapeutic that has been discovered and developed for the treatment of ulcerative colitis, using Microba's data-driven Therapeutics Platform. The planned Phase 1 clinical trial will involve 32 healthy participants and be conducted by Nucleus Network utilising their world class clinical trial facilities in Melbourne.

Microba has appointed Beyond Drug Development as the contract research organisation to support the study. The clinical trial is structured as a randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of MAP 315 in healthy adults. Inflammatory Bowel Disease (IBD) - Large unmet need & commercial opportunity.

IBD is a term for conditions that cause prolonged inflammation of the digestive tract and now affects more than 7 million people globally, with this number increasing each year. Ulcerative colitis (UC) is one of the two major forms of IBD which results in inflammation and ulcers (sores) in the digestive tract, causing a debilitating chronic condition. Patients are currently treated with anti-inflammatory and immunomodulatory medication to dampen the disease and control symptoms, often with significant side effects.

These available treatment options commonly fail, with more than 50% of patients unable to achieve sustained remission, which sees them experiencing regular episodes of inflammation, diarrhoea, bleeding and abdominal pain, with as many as 25% of patients requiring hospitalisation. The market for ulcerative colitis treatment was valued at USD 7.5 billion in 2020 and is forecast to grow to USD 10.8 billion by 2030.