- Pfizer said Wednesday an experimental drug central to its $7 billion purchase of Arena Pharmaceuticals succeeded in a crucial Phase 3 trial in patients with moderate to severe ulcerative colitis.
- The study, dubbed Elevate 12, found that patients given the former Arena drug etrasimod had meaningfully higher remission rates after 12 weeks than those who received a placebo. The New York-based drugmaker didn’t give details, saying the findings would be submitted for publication and presented at a scientific setting.
- Results from another, longer pivotal study, Elevate 52, will be released by the end of the month, Pfizer said. The company expects to use both trials to seek Food and Drug Administration approval of etrasimod for patients with ulcerative colitis.
The success of Pfizer’s Arena deal rests largely on etrasimod, the most advanced inflammatory drug in the San Diego biotech’s portfolio. Before refashioning itself as an inflammatory specialist, Arena was probably best known for the obesity drug Belviq, which struggled commercially.
Pfizer executives pursued the company without the pivotal results for etrasimod in hand, though executives were able to view blinded data from Elevate 12 and Elevate 52 that suggested the drug was working in ulcerative colitis. Researchers are also investigating the pill’s benefits in patients with Crohn’s disease, atopic dermatitis, eosinophilic esophagitis and alopecia areata.
The drug works by targeting a signaling molecule known as sphingosine-1 phosphate, or S1P, which scientists believe plays a role in inflammation. Bristol Myers Squibb’s Zeposia, already approved to treat ulcerative colitis, also acts on S1P. Arena has long felt its drug is more effective than Zeposia, and Pfizer executives echoed those sentiments upon acquiring the biotech, with Mike Gladstone, the head of its inflammation and immunology division, saying the medicine has the "potential for best-in-class efficacy."
A clear edge over Zeposia would be a needed boost for Pfizer, whose business treating inflammatory diseases has been slowed by safety concerns. Critical study details from Elevate 12 — and, if successful, Elevate 52 — will have to bear out that hypothesis, however.
Pfizer closed the Arena deal earlier this month, after a slower-than-expected antitrust review process. Investors feared that the Federal Trade Commission might object to the deal because of both companies’ strengths in anti-inflammatory medicines, but in the end the agency didn’t require any divestitures or asset sales.