An investigational IL-23 receptor blocker showed promising one year efficacy in plaque psoriasis patients in results from a phase 2b trial.

In late-breaking trial data reported at AAD 24, the therapy known as JNJ-2113 showed sustained efficacy from Week 16 to Week 52 in the long-term extension FRONTIER 2 study.

In a study sponsored by Johnson & Johnson, the targeted oral peptide therapy was assessed in 227 patients with  moderate-to-severe plaque psoriasis who had taken part in the preceding 16-week FRONTIER 1 randomised controlled trial.

When treatment was continued, patients high rates of skin clearance were maintained through 52 weeks, as measured by the Psoriasis Area and Severity Index (PASI).

The highest PASI 75 response was observed in the 100 mg twice daily group (78.6 at 16 weeks and 76.2% at 52 weeks).

Responses were also maintained to week 52 for the key secondary endpoints of PASI 90 (59.5 at 16 weeks and 64.3% at 52 weeks), PASI 100 (40.5% at 16 weeks and 40.5% at 52 weeks), Investigator’s Global Assessment (IGA)c 0/1 (64.3% at 16 weeks and 73.8% at 52 weeks) and IGA 0 (45.25 at 16 weeks and 42.9% at 52 weeks).

Safety outcomes in the long-term extension study were found to be consistent with the preceding study.

The most frequently reported adverse events were nasopharyngitis (18.1%), and upper respiratory tract infection (9.7%), with serious adverse events occurring in 4% of the combined treatment groups, all of which were considered unrelated to study treatment.

“Data from the FRONTIER 2 study showed that the skin clearance as seen by PASI 75 and higher-bar PASI 90 and 100 responses at 16 weeks was maintained at 52 weeks with no new safety signals across all JNJ-2113 treatment groups,” said study investigator Professor Laura Ferris, Professor of Dermatology, University of Pittsburgh.

“These findings suggest the potential for JNJ-2113 to continue delivering clinically meaningful results, and addresses the high unmet need for a novel, durable, and convenient oral therapeutic option for people living with moderate-to-severe plaque psoriasis.”

Sponsor Johnson & Johnson said the Phase 3 ICONIC clinical development program is currently underway to evaluate the safety and efficacy of JNJ-2113 in adults with moderate-to-severe plaque psoriasis