Vendanta Biosciences will be stopping development of its oral microbiome therapy, VE202, which failed to meet its primary endpoint in a Phase II trial in mild-to-moderate ulcerative colitis (UC).
VE202 failed to show improvement in endoscopic response in UC patients in the randomised, double-blind, placebo-controlled COLLECTiVE202 study (NCT05370885), with Vendanta CEO Dr Bernat Olle confirming on LinkedIn that the drug will not be moving forward.
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In the press release confirming the trial failure, Olle said: “We are very disappointed that our study did not meet its efficacy endpoints, and our greatest regret is that people living with inflammatory bowel disease will not, for now, have the opportunity to benefit from a new treatment option.
“The gut microbiome is a well-recognised driver of IBD [inflammatory bowel disease], yet remains a facet of the disease untouched by current treatments. As a field, we have not yet succeeded in making a meaningful impact for people with IBD through microbiome-based approaches, but every study moves us closer to that goal.”
Vendanta will be sharing further analyses of the UC trial at upcoming scientific meetings.
Due to the Phase II failure, Vendanta will be reducing its workforce by 20%, Olle also confirmed in his social media post.
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By GlobalDataAmid the failure, the company said it is now focusing efforts on other pipeline assets, primarily VE303, which is in a Phase III registrational study for the prevention of recurrent C. difficile infection (rCDI). A Phase II trial of the drug demonstrated potentially best-in-disease efficacy with a 30.5% absolute risk reduction and a greater than 80% reduction in the possibility of CDI recurrence.
Olle added: “Our priority at Vedanta remains the successful execution of our ongoing global pivotal study of VE303 for the prevention of recurrent C. difficile infection, with the goal of potentially delivering the first approved live biotherapeutic product in any indication — and, in doing so, addressing a serious health condition with a significant unmet medical need.”
The company’s other clinical asset, VE707, will be investigated for its ability to prevent infections by multi-drug-resistant organisms that affect a wide range of vulnerable populations in areas such as oncology, urology, transplantation, and critical care. The investigational new drug (IND) submission for VE707 is planned for H1 2026.
UC market remains competitive
A large number of biologics have also been approved in UC, with the first being Janssen’s Remicade (infliximab), which gained US Food and Drug Administration (FDA) approval in 2005.
Since then, AbbVie’s Humira (adalimumab), Takeda’s Entyvio (vedolizumab), and Johnson & Johnson’s Stelara (ustekinumab) have also all gained approval in the UC sector.
As biosimilars for Humira began to enter the market in 2023, AbbVie is hoping to regain some control in the UC market with Skyrizi (risankizumab-rzaa) after it was approved in June 2024. It recently culled an IL-1 asset as a monotherapy for UC after it failed to show benefit in a Phase II trial.
A company that could be set to make its mark in UC is Abivax, with the company’s stock surging more than 500% after its first-in-class miRNA regulator, obefazimod, showed an average 16.4% placebo-adjusted clinical remission rate across two Phase III trials.
According to GlobalData, the UC market across the eight major markets (the US, France, Germany, Italy, Spain, the UK, Japan, and Canada) will reach $10bn in 2031.
GlobalData is the parent company of Clinical Trials Arena.
