cAMPfield Therapeutics said its investigational drug prifemilast met both co-primary endpoints and showed greater efficacy than apremilast in a head-to-head Phase 3 trial in adults with moderate-to-severe plaque psoriasis. The company said the study was one of three randomised, double-blind, multicentre psoriasis trials sponsored and conducted in China by its partner Newsoara Biopharma, and that results from the trials were presented in two posters at the 2026 Fall Clinical Dermatology Conference in Las Vegas.
In the head-to-head trial, prifemilast 20 mg once daily was superior to apremilast 30 mg twice daily on both co-primary endpoints at Week 16. The company said 64.6% of patients on prifemilast reached at least a 75% improvement in the Psoriasis Area and Severity Index, against 35.3% on apremilast, while 55.6% versus 31.3% achieved clear or almost clear skin, measured as a score of 0 or 1 on the sPGA scale. Both results were reported at p < 0.0001. Serious adverse events were reported in 4.0% of prifemilast patients and 2.5% of those on apremilast, and discontinuations due to adverse events in 2.0% and 1.5% respectively.
The trial randomised 607 participants 2:1 to prifemilast or apremilast for 16 weeks, with apremilast titrated in line with its US prescribing information and prifemilast requiring no titration, the company said. In a separate placebo-controlled Phase 3 trial, it said responses appeared as early as Week 2 and were maintained through 52 weeks, with discontinuations due to adverse events over the 16-week treatment period similar between prifemilast and placebo (1.7%–1.8% vs. 1.8%). More than 1,000 participants have been dosed with prifemilast, the company said, including more than 250 treated for 52 weeks.
cAMPfield said it is advancing prifemilast into global Phase 2 trials in ulcerative colitis and Crohn's disease, and that Newsoara plans to submit a new drug application for the drug in plaque psoriasis in China by the end of 2026. Prifemilast is investigational and has not been approved by any regulatory authority for any indication, the company said. The conference posters are available on the cAMPfield website.
