Innovent's PECONDLE Delivers Durable Efficacy And Safety In Phase 3 Psoriasis Trial

(RTTNews) - Innovent Biologics, Inc. (HKEX: 01801), a leading biopharmaceutical company, announced that PECONDLE (picankibart injection), its self-developed recombinant anti-interleukin-23p19 subunit monoclonal antibody, achieved both primary and key secondary efficacy endpoints in the Phase 3 CLEAR-2 study. This randomized withdrawal and retreatment trial was conducted in Chinese participants with moderate-to-severe plaque psoriasis.

PECONDLE is the first China-developed IL-23p19 monoclonal antibody and received market approval from the National Medical Products Administration (NMPA) in November 2025 for adult patients with moderate-to-severe plaque psoriasis eligible for systemic therapy.

The CLEAR-2 study was a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial. A total of 566 participants received picankibart treatment through Week 32. Those achieving =90% improvement in Psoriasis Area Severity Index (PASI 90) were re-randomized to either maintenance treatment with picankibart (100 mg or 200 mg) or placebo withdrawal. The primary endpoint was the proportion of participants maintaining PASI 90 response at Week 56, a validated measure of sustained high-level lesion clearance.

At Week 56, PASI 90 response was maintained in 89.3% of patients in the 100 mg group and 90.1% in the 200 mg group, both significantly higher than the withdrawal groups (37.7% and 51.7%; P < 0.0001). These results confirm that quarterly dosing of picankibart provides durable and superior efficacy compared to treatment withdrawal.

All key secondary endpoints were met. Patients in the maintenance groups achieved significantly higher rates of PASI 75, PASI 100 (complete clearance), sPGA scores of 0 or 1, sPGA score of 0 (clear skin), and DLQI scores of 0/1 (indicating improved quality of life) compared with withdrawal groups (P < 0.0001 for all). These findings highlight picankibart's ability to deliver comprehensive and durable clinical benefits.

Picankibart demonstrated durable efficacy even after treatment withdrawal. Median efficacy durability in withdrawal groups was 20.4 weeks and 24.6 weeks, while maintenance treatment significantly reduced relapse risk (P < 0.0001). Nearly half of withdrawal patients maintained PASI 90 response after 24 weeks off therapy, underscoring picankibart's disease-modifying potential in achieving deep skin clearance.

Picankibart maintained a favorable safety profile throughout the study, with no new safety signals observed compared to previous clinical trials.

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