cAMPfield's Prifemilast Demonstrates Superior Efficacy in Psoriasis Trial
News related to:cAMPfield Therapeutics Inc · 2 min read
cAMPfield Therapeutics Inc has announced significant advancements in its investigational drug prifemilast, a once-daily, preferential PDE4B inhibitor, in treating moderate-to-severe plaque psoriasis. The drug demonstrated superior efficacy compared to apremilast in a head-to-head Phase 3 trial, nearly doubling the rate of PASI 75 response.
In the head-to-head Phase 3 trial, prifemilast 20 mg once daily achieved superiority over apremilast 30 mg twice daily on both co-primary endpoints at Week 16. The results showed that 64.6% of patients treated with prifemilast achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75), compared to 35.3% for apremilast. Additionally, 55.6% of patients treated with prifemilast achieved clear or almost clear skin (sPGA 0/1), compared to 31.3% for apremilast. These differences were statistically significant (P<0.0001).
The trial also reported low rates of serious adverse events (4.0% vs. 2.5%) and discontinuations due to adverse events (2.0% vs. 1.5%) between the two treatment arms. Discontinuations due to adverse events during the 16-week treatment period were similar with prifemilast and placebo (1.7%, 1.8% vs. 1.8%).
The company has also advanced prifemilast into global Phase 2 trials for ulcerative colitis and Crohn's disease, two inflammatory bowel diseases that share overlapping inflammatory pathways with psoriasis. In a Phase 2 trial in patients with ulcerative colitis, apremilast did not meet its primary endpoint at 40 mg twice daily, but at 30 mg twice daily, 31.6% of patients achieved clinical remission at Week 12, compared to 12.1% on placebo.
Prifemilast has been studied in more than 1,000 participants, including more than 250 treated for 52 weeks. The extensive clinical safety database supports the drug's potential to deliver greater efficacy than apremilast, with a favorable tolerability and safety profile.
The Phase 3 trial (NCT07712731) randomized 607 participants 2:1 to prifemilast 20 mg once daily or apremilast 30 mg twice daily for 16 weeks. Apremilast was titrated in line with its US prescribing information, while prifemilast required no titration. The co-primary endpoints were the proportion of patients achieving PASI 75 and sPGA 0/1 at Week 16.
The placebo-controlled Phase 3 trial (NCT07712705) randomized more than 500 participants to prifemilast 10 mg, prifemilast 20 mg, or placebo once daily for 16 weeks, followed by a 36-week extension in which all participants received prifemilast. The Phase 2 dose-ranging trial (NCT07707141) randomized 123 participants to prifemilast 6 mg, 10 mg, or 20 mg or placebo once daily for 12 weeks and showed dose-dependent improvements.
These positive results reinforce the potential of prifemilast to treat immune-mediated inflammatory diseases beyond psoriasis, with the company planning to advance the drug into global Phase 2 trials in ulcerative colitis and Crohn's disease.