Microba Life Sciences has dosed the first participants in a Phase I clinical trial of MAP 315, a live biotherapeutic product in development for the treatment of ulcerative colitis (UC).
The placebo-controlled, double-blind, randomised study is designed to assess the pharmacokinetics, tolerability, and safety of the orally administered MAP 315 in healthy adults.
It will enrol a total of 32 healthy adults, who will be divided into two cohorts of 16 subjects each.
They will be randomised into a 3:1 ratio to receive MAP 315 or its matching placebo for 14 consecutive days.
To supply material for the trial, Microba, along with Bacthera, is manufacturing MAP 315 on a large scale at its facilities in Europe.
Microba Life Sciences Therapeutics senior vice-president professor Trent Munro said: “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 (IBD) sufferers.”
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Results from the trial are anticipated in December this year.
Australia-based Nucleus Network is conducting the trial of MAP 315, under approval from Microba’s Human Research Ethics Committee (HREC).
MAP 315 was developed using a data-driven therapeutics platform and consists of lyophilised bacteria in an enteric coated capsule.
It is a part of Microba’s therapeutic programme in IBD for developing new treatment options for people suffering with UC.
UC is one of the two major forms of IBD that causes inflammation and ulcers (sores) in the digestive tract, causing a debilitating chronic condition.