Roivant Sciences on Thursday revealed more positive results for a closely watched experimental drug being developed as a treatment for different kinds of inflammatory bowel disease.
The drug, now known as RVT-3101, targets a protein that regulates inflammation and fibrosis, and has advanced into mid-stage clinical trials where researchers are testing multiple doses of it in patients with moderate-to-severe Crohn’s disease or ulcerative colitis. The newly released data are from the second portion of the ulcerative colitis study, and indicate longer exposure to the drug benefited patients.
After 56 weeks of treatment, 36% of participants who received the dose of RVT-3101 that’s going to be further developed had achieved “clinical remission,” meaning their disease almost, if not fully, cleared up. After 14 weeks of treatment, which marked the end of the study’s first portion, 27% of participants had demonstrated clinical remission at this dose.
Other measures of bowel health also got better between those two time points. Half of these participants had “endoscopic improvement” — or inactive to mild disease — at the 56-week mark, compared to 36% at the 14-week mark. And those experiencing endoscopic remission, defined as inactive disease, also jumped from 11% to 21%.
Numbers across all three of these measures were higher, too, when looking at a subset of participants who tested positive for a “prospectively defined biomarker” that researchers identified earlier in the study.
Roivant said there were no safety signals in the trial and that patients tolerated RVT-3101 well. During the second portion of the study, 5% of all patients receiving the drug and 14% of those on the dose that’s advancing into further testing experienced serious adverse events. But, according to Roivant, these events were sporadic and determined not to be related to treatment.
The results “categorically exceeded” Roivant’s expectations, CEO Matt Gline said in a statement. If they’re confirmed through late-stage clinical testing, then RVT-3101 “has the potential to transform the treatment paradigm” for inflammatory bowel disease, which is “marked by low remission rates and poor persistence of effect.”
Roivant shares were up more than 11% late Thursday morning, trading at $11.65 apiece.
The new data “should settle any major investment concerns” about the drug’s effectiveness, Dennis Ding, an analyst at the investment bank Jefferies, wrote in a note to clients. Additionally, the trial outcome “supports our positive outlook that RVT-3101 could be a multi-billion blockbuster IBD drug.”
Others also see a lucrative opportunity for therapies like RVT-3101, which acts on a protein called T1LA.
In April, Merck & Co. agreed to buy San Diego-based Prometheus Biosciences for just shy of $11 billion — representing a roughly 75% deal premium. Prometheus has its own T1LA-targeting medicine, which delivered positive results across a pair of mid-stage studies that tested it against moderate-to-severe ulcerative colitis and hard-to-treat Crohn’s disease. Teva has a similar drug in Phase 2 trials as well.
Roivant gained access to RVT-3101 through a licensing deal with Pfizer. The companies have set up a Roivant subsidiary responsible for further development of the drug. Pfizer holds a a 25% equity position in the subsidiary and continues to retain commercial rights outside of the U.S. and Japan.
Correction: This story has been updated to clarify the disease indication for Roivant's drug.