A race to develop a new kind of treatment for inflammatory bowel disease heated up Wednesday, with the release of positive data for an experimental drug that’s backed by Pfizer and Roivant Sciences.
The data come from the first portion of a two-part clinical trial named TUSCANY-2, which has enrolled nearly 250 people with moderate-to-severe ulcerative colitis. In this first “induction” portion, researchers spent 12 weeks comparing different doses of the Pfizer and Roivant drug, called RVT-3101, against a placebo. Participants who received the drug were given three different doses, each spaced a month apart.
Now, Roivant is saying that at each dose tested, the drug “demonstrated statistically significant and clinically meaningful efficacy.”
According to the company, 32% of participants treated with RVT-3101 during the trial’s induction stage achieved clinical remission, as defined by a scorecard commonly used to gauge the severity of ulcerative colitis. Among placebo-treated patients, 12% reached clinical remission.
The drug group also had a greater proportion of patients showing “endoscopic improvement,” with 40% hitting that goal compared to 19% in the placebo arm.
As for safety, the drug was “well tolerated and showed a favorable safety profile” across the various doses and patient groups, Roivant said.
With these results in hand, the plan, according to Roivant, is to progress RVT-3101 into clinical studies that could serve as the backbone for approval applications. Last month, Roivant and Pfizer announced the formation of a new company that would handle the drug’s development and some of its commercialization.
The fresh data come just several weeks after Prometheus Biosciences, a San Diego-based drugmaker, revealed that one of its experimental medicines had scored positive results in an ulcerative colitis study as well as another clinical trial focused on Crohn’s disease. Similar to Roivant, the results have encouraged Prometheus to push its drug into pivotal testing.
Prometheus’ medicine and Roivant and Pfizer’s drug both act on a protein called TL1A, which regulates inflammation and fibrosis. The companies each claim that their respective treatment has the potential to be not only the first TL1A-targeting agent on the market, but also the best.
On Wall Street, analysts are torn about which treatment holds the advantage. Louise Chen, who covers Roivant for Cantor Fitzgerald, wrote in a note to clients Wednesday that her team views the fresh induction data as superior to what was seen with Prometheus’ drug. But Chris Howerton, who covers Prometheus for Jefferies, took the opposite stance, arguing in his own note that Prometheus’ drug had a higher remission rate and greater endoscopic improvement when adjusted for placebo responses.
What analysts do seem to agree on is that the Prometheus and Roivant data help to validate TL1A as a target for treating inflammatory bowel disease.
The results released Wednesday are “good for the TL1A class and suggests the mechanism is clearly active,” according to Jefferies analyst Dennis Ding, who wrote that RVT-3101 could become a blockbuster franchise.
Notably, the studies of both RVT-3101 and Prometheus’ drug enrolled patients whose conditions had not been adequately addressed with other therapies. If approved, analysts expect these medicines could be seen as valuable new options for hard-to-treat ulcerative colitis or Crohn’s disease.