Roivant Reports Positive Results in Phase II Ulcerative Colitis Trial

Pictured: Cat scan of abdomen/Courtesy Sutthaburawonk, iStock

Pictured: Cat scan of abdomen/Courtesy Sutthaburawonk, iStock

Thursday, Roivant Sciences announced positive results from a Phase IIb trial of a closely watched treatment for different kinds of inflammatory bowel disease. RVT-3101, a monthly subcutaneously administered anti-TL1A antibody, showed positive results in patients with moderate to severe ulcerative colitis.

The results set the stage for a Phase III trial, using a dose of the drug that Roivant has not yet revealed. The trial, called TUSCANY-2, is testing several dosing strategies over different time periods. The new results come from measurements taken in week 56 of the Phase IIb trial’s chronic period, in which all patients received the drug.

After 56 weeks of treatment, 36% of participants who received the optimum dose of RVT-3101 had achieved “clinical remission,” which indicates their disease almost cleared up. That’s a significant improvement on the 29% of participants on the same dose who showed clinical remission after 14 weeks of treatment, which was the end of the trial’s first period.

The results indicate the long-term benefit of taking the drug, which targets a protein that regulates inflammation and fibrosis.

The 56-week results showed other improvements over the 14-week progress. The number of participants showing “endoscopic improvement,” which signals inactive or mild disease, was 50% at week 56, up from 36% at week 14. And 21% showed endoscopic remission (inactive disease) at week 56, compared with 11% at week 14.

The results were better still for participants who carry a biomarker identified earlier in the study, Roivant said. Some 43% of these people showed clinical remission at week 56, compared with 33% at week 14. Some 64% showed endoscopic improvement at week 56, up from 47% at week 14. In addition, 36% showed endoscopic remission at week 56, compared to 13% at week 14.

The drug appeared to be well-tolerated through 56 weeks across all doses with immunogenicity impact on clinical efficacy or safety results, the company said.

“Our expectations for this chronic data were categorically exceeded,” Roivant CEO Matt Gline said in a statement. If confirmed in Phase III, the drug could “transform the treatment paradigm” for inflammatory bowel disease, Gline added, a condition with low remission rates and poor persistence of effect.

During the second portion of the study, 5% of all patients receiving the drug and 14% of those on the optimum dose experienced serious adverse events. Roivant contends these were sporadic and not related to the treatment.

Roivant secured RVT-3101 through a licensing deal with Pfizer. Pfizer holds a 25% equity position in the subsidiary the two firms set up to develop the drug, retaining commercial rights outside Japan and the U.S. Rival firms including Merck, through its Prometheus acquisition, are testing similar drugs.

David Adam is a freelance science journalist based in the UK. Reach him at davidneiladam@gmail.com.

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