Telavant has kickstarted its trial investigating its treatment candidate RVT-3101 for Crohn’s disease (CD), completing the first patient dosing.

The TAHOE study (NCT05910528) is a global, randomised, double-blind study in a predicted 105 participants with moderate to severely active CD. Telavant, part of Roivant, is evaluating two doses of RVT-3101 administered once a month, with patient assessment at week 14. The primary endpoint is the proportion of participants achieving clinical remission per Crohn’s Disease Activity Index (CDAI). The secondary outcome is the proportion of participants achieving an endoscopic response.

RVT-3101 is a drug being investigated for other bowel disease indications. In June, Roivant announced positive results from a Phase 2b study (TUSCANY-2) indicating improved clinical remission in ulcerative colitis.

The Wall Street Journal recently reported that Roivant is in talks to sell the drug to Roche for a potential $7bn deal.

“Despite the availability of multiple treatment options, many Crohn’s disease patients do not achieve adequate disease control,” said Professor Geert D’Haens, gastroenterologist and investigator at Amsterdam UMC.

“TL1A provides a compelling therapeutic target to treat inflammatory bowel diseases (IBD) and the IBD community is excited about the potential for RVT-3101 as a new treatment approach for UC and CD patients.”

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Inflammatory bowel diseases (IBD), which include CD and ulcerative colitis, are estimated to affect around 2 million US adults. Telavant says that even the most advanced therapies typically lead to a 10-15% disease remission, meaning flare-ups and continued symptoms are still an issue. It adds that no approved medication directly addresses the fibrotic component of IBS. 

“We are excited to broaden the potential of RVT-3101 with the initiation of the TAHOE Phase 2 study as we believe its novel mechanism of action, addressing both inflammation and fibrosis, can make a significant impact on patients suffering with Crohn’s disease,” said Bittoo Kanwar, chief medical officer of Telavant.