Microbiotica raises £36 Million ($48 Million) in Series C financing to advance pipeline into Phase 2 clinical development

Microbiotica, a clinical-stage biopharma company developing a pipeline of orally-dosed, precision microbiome medicines, today announces the first close of a £36 million ($48 million) Series C financing.

The financing was led by British Business Bank, with participation from Tencent, IP Group, Cambridge Innovation Capital, Flerie Invest, and Seventure Partners. All existing Series B investors participated in the financing.

Proceeds will support the advancement of MB310 into Phase 2 clinical development in ulcerative colitis, following positive results from the COMPOSER-1 Phase 1b study, which met its primary and secondary endpoints and demonstrated statistically significant improvements in clinical remission versus placebo. MB310 also showed disease modifying potential through improvements in histological measures and markers of intestinal epithelial barrier integrity. The randomised, double-blind, placebo controlled Phase 2 study will seek to confirm these highly encouraging early results.

MB310 targets a significant unmet need in ulcerative colitis

Ulcerative colitis is the most common form of inflammatory bowel disease and is a major debilitating disease that affects up to 5 million people globally. Despite available treatments, many patients do not achieve or maintain remission, highlighting the need for new therapeutic approaches. MB310 is a once-daily oral capsule comprised of a consortium of eight specific live gut commensal bacterial strains. Its differentiated mechanism of action promotes gut epithelial barrier repair and delivers anti-inflammatory effects, directly addressing the key drivers of disease which, together with its favourable safety profile, makes it ideally placed to be combined with existing ulcerative colitis products.

Carmine Circelli, Senior Investment Director, Life Sciences at the British Business Bank, commented: “We believe Microbiotica is emerging as a world leader in the development of microbiome therapeutics. Its Phase 1b study in ulcerative colitis produced statistically significant clinical remission, best in disease potential with no safety issues. This funding allows the Company to move MB310 forward into a Phase 2 trial which, if it confirms the promise seen in Phase 1b, has the potential to be a major breakthrough in the treatment of ulcerative colitis. By investing in companies like Microbiotica, we help the UK’s most promising life sciences companies to convert research into treatments while also building the UK’s thriving life sciences market.”

A unique genomics-driven microbiome platform

Spun out of the Wellcome Sanger Institute in 2016, Microbiotica has a unique genomics-driven microbiome platform which combines a diverse microbiome culture collection, a proprietary human Reference Genome Database, advanced bioinformatics, and machine learning tools. When this platform is applied to clinical trial datasets, it can precisely identify bacteria associated with favourable clinical trial outcomes in specific patient populations. This clinical-data led approach informs the selection of bacterial strains for therapeutic development with the potential to improve the likelihood of clinical success.

The Company has established partnerships with MSD, Cancer Research UK, Genentech, The University of Adelaide and Cambridge University Hospitals NHS Foundation Trust.

The platform is also supporting the development of Microbiotica’s broader pipeline. The Company is advancing MB097, its precision microbiome asset for patients with advanced melanoma. Emerging clinical data from the ongoing Phase 1b MELODY-1 study has demonstrated encouraging results when MB097 is administered in combination with KEYTRUDA^® (pembrolizumab), MSD’s anti-PD-1 therapy.

Dr Sam Williams, Venture Partner at IP Group, said:

We have been very impressed by Microbiotica’s progress since we first invested in the Company, from translating pioneering microbiome science from the Wellcome Sanger Institute into a powerful genomics-driven microbiome platform that has generated promising efficacy in two Phase 1b clinical trials. There is an important opportunity to advance Microbiotica’s precision microbiome approach into a larger clinical study, and we are pleased to continue supporting the Company as it enters this next phase of development.

Tim Sharpington, Chief Executive Officer of Microbiotica, added:

This financing marks an important next stage for Microbiotica and reflects the significant progress we have made in translating our powerful genomics-driven microbiome platform into clinical-stage products, alongside developing a scalable and cost-effective manufacturing process. The strong Phase 1b results for MB310, together with the positive clinical data from our immuno-oncology programme, provide important validation of our approach. We are thankful for the support received from our investors and are now focused on taking MB310 into Phase 2 clinical development, where we have an opportunity to further establish MB310 as a breakthrough treatment option for people living with ulcerative colitis.