Successful IBD Phase I Clinical Trial

Microba Life Sciences today announced initial unblinded data from the Phase 1 Clinical Trial of lead drug candidate MAP 315, in Microba’s Inflammatory Bowel Disease (IBD) Therapeutic Program. These results demonstrate a strong safety and tolerability profile for MAP 315, and support the continued clinical development of the lead drug candidate. This is an important clinical development milestone for MAP 315 as a potential new treatment option for the millions of people suffering from ulcerative colitis.

Professor Trent Munro, SVP 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.”

Summary of Key MAP315-001 Study Results:

• MAP 315 had a favourable safety and tolerability profile across both low and high-dose cohorts
• There were no clinically significant safety signals from safety assessments including ECGs and laboratory analysis of haematology, coagulation, clinical chemistry or urinalysis parameters
• There was no evidence of translocation of MAP 315 into the bloodstream
• There was no impact on inflammatory biomarkers
• All participants completed the study and all dosing
• All reported adverse events (AEs) were mild (e.g. headache), with a higher proportion reported in the placebo group and there were no AEs that lead to study discontinuation or drug withdrawal
• Treatment related AEs were minimal, transient and comparable between the MAP 315 and placebo treatment groups
• Ongoing assessment of faecal kinetics by metagenomic analysis detects the presence of MAP 315 at the terminal 28-day analysis timepoint, 14 days after the completion of dosing, indicating the ability to successfully deliver live MAP 315 into the gastrointestinal tract.

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.

MAP 315 Phase 1 Clinical Trial Details

The clinical trial was titled “A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Syudy to Evaluate the Safety, Tolerability and Pharmacokinetics of MAP 315 in Healthy Adults”. The study enrolled 2 cohorts of 16 participants each, who were randomised 3:1 to receive MAP 315 or its matching placebo for 14 consecutive days (2 weeks). Cohort 1 received a low dose of 1 capsule/day of MAP 315 while Cohort 2 received high dose of 8 capsules/day of MAP 315. The trial was conducted by Nucleus Network in Melbourne, Australia, under our Human Research Ethics Committee (HREC) approval and in alignment with formal feedback received from an FDA pre-IND engagement. Full study details can also be found in the Australian New Zealand Clinical Trials Registry (ANZCTR) under study ID: ACTRN12623000291684.

Microba’s Novel Drug Candidate MAP 315

MAP 315 was identified using Microba’s unique analysis of its large proprietary human databank, demonstrating that this previously uncharacterized and novel bacterial species is commonly observed in healthy individuals but consistently deficient in individuals with IBD. Subsequent pre-clinical investigation of MAP 315 through both in vitro and in vivo models demonstrated that MAP 315 promotes epithelial restitution and mucosal healing – biological activities that are critical for sustained disease remission but not adequately addressed through existing therapy.

MAP 315 is a live biotherapeutic product (LBP) consisting if lyophilisised bacteria in an enteric coated capsule which is orally administered and being as an investigational product for the treatment of ulcerative colitis (UC). Microba worked in partnership with leading microbiome contract drug ,manufacturer Bacthera to produce GMP compliant MAP 315 at large-scale in their state-of-the-art facilities in Europe to supply material for the MAP 315 clinical trial.

Inflammatory Bowel Disease – Large unmet need

IBD causes prolonged inflammation of the digestive tract and now affects more than 7 million people globally, with this number increasing each year¹. 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-effects.

These available treatment options commonly fail, with more than 50% of patients unable to achieve sustained remission², which sees them experiencing regular episodes of inflammation, diarrhoea, bleeding and abdominal pain³, with as many as 25% of patients requiring hospitalisation⁴. The market for UC treatment was valued at US$10.8 billion by 2030⁵. Microba’s novel drug candidate MAP 315 presents an opportunity to improve the current standard of care and treatment for millions of people suffering from the debilitating effects of UC.

Therapeutic Platform & Programs

There is a growing body of evidence that the gut microbiome plays a central role in the maintenance of health and the development of chronic disease. With microbiome-based therapeutics now in clinical development and the first FDA approvals, these novel drugs represent an exciting new opportunity for the treatment of chronic diseases that are underserved by current pharmaceuticals.

Microba is at the forefront of this field using its advanced proprietary metagenomics technology developed by leading Australian researchers in the top 1% of cited researchers globally. Using this technology, MIcroba has established a data-driven platform for drug discovery and development from the human gut microbiome. This platform leverages a large, growing, proprietary databank collected through the Company’s Microbiome Testing Services, and is generating multiple potent therapeutic candidates to address chronic diseases. Microba has established three therapeutic programs spanning IBD, Immuno-Oncology and Autoimmune Diseases, with lead candidate MAP 315 under the Company’s IBD program the first program to enter human clinical trials.