Vedanta will use the funds to advance its lead asset VE303 in clostridioides difficile infection and support the development of another candidate in ulcerative colitis.
Pictured: A pile of $100 bills/ElenaR/Adobe Stock
Vedanta Biosciences closed a $106.5 million funding round on Tuesday to support a pivotal Phase III study of its candidate VE303 for Clostridioides difficile (C. diff) infection.
In addition to the Phase III study, Vedanta stated it plans to use the funds to run a proof-of-concept Phase II trial studying VE202, its investigational treatment for ulcerative colitis.
The financing push was led by AXA IM Alts and The AMR Action Fund, both new investors, along with existing investors, including the Bill & Melinda Gates Foundation, Atlantic Neptune and Skyviews Life Science. QUAD Investment Management and Pfizer also participated in the financing round.
Vedanta is advancing a potentially new class of oral, microbiome-based treatments based on defined bacterial consortia, which are standardized assemblies of bacteria composed of specific strains that work synergistically, resulting in a therapeutic effect.
This approach offers a more targeted and holistic approach compared with other microbiome-based treatment regimens, according to Vedanta. Fecal transplantation, for instance, requires donors and is a generally untargeted procedure. Meanwhile, single-strain probiotics lack the robust effects of multi-strain interventions.
Vedanta’s proprietary discovery and development platform includes a deep and diverse library of bacterial strains and makes use of bioinformatic tools to optimally assemble different strains into a therapeutic consortium.
The company’s most mature asset, VE303, is a defined bacterial consortium candidate that consists of eight commensal bacterial strains that provide resistance to C. diff colonization.
On April 17, Vedanta published Phase II data for VE303 in the Journal of American Medical Association that showed the bacterial consortium candidate was effective at preventing C. diff recurrence.
In patients treated with high-dose VE303, the rate of recurrence was 13.8% at the 8-week follow-up. Placebo comparators, on the other hand, saw a 45.5% recurrence rate. The treatment effect was statistically significant, according to the publication.
Curt LaBell, managing partner of global healthcare strategies at AXA IM Alts, Martin Heidecker, chief investment officer of The AMR Action Fund and Neil Tiwari, technology investor at Magnetar Capital, will join the board of directors. Meanwhile, two sitting directors, including newly appointed Biogen CEO Christopher Viehbacher, will leave the company.
C. diff Competition Heats Up
Tuesday’s announcement comes one day before the FDA is set to decide on Seres Therapeutics’ investigational microbiome-based candidate, SER-109.
If approved, SER-109 would be the first-ever oral microbiome therapeutic.
SER-109’s Biologics License Application is backed by data from its Phase III development program, including ECOSPOR III and ECOSPOR IV.
ECOSPOR III is a randomized and placebo-controlled study that found that SER-109 was able to reduce CDI recurrence by 88% in treated patients, while placebo comparators only saw a 60% recurrence-free rate. ECOSPOR IV, an open-label extension study of ECOSPOR III, demonstrated the candidate’s good safety and tolerability profile at its proposed commercial dose.
Also in the C. diff space is Ferring Pharmaceuticals, whose Rebyota (fecal microbiota, live-jslm) was approved in November 2022 by the FDA as the first-ever fecal microbiota-based live biotherapeutic product.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com
