#China #Suzhou #Psoriasis #Innovent #PECONDLE

Innovent's Breakthrough in Psoriasis Management with PECONDLE®

Innovent Biologics, Inc. (HKEX: 01801), renowned for its excellence in biopharmaceuticals, has recently made headlines with its innovative treatment PECONDLE® (picankibart injection). This monoclonal antibody, specifically designed to target and inhibit the IL-23p19 subunit, has shown remarkable efficacy in the Phase 3 CLEAR-2 study for patients suffering from moderate-to-severe psoriasis.

Trial Overview

Conducted as a double-blind, placebo-controlled study, the CLEAR-2 trial enrolled 566 participants across multiple centers in China. This robust design aimed to evaluate both the efficacy and long-term effects of picankibart during maintenance therapy following initial treatment success. The participants who achieved at least a 90% improvement in their Psoriasis Area Severity Index (PASI 90) at Week 32 were subsequently randomized to either continue with picankibart or switch to a placebo.

Key Findings

The results were compelling. At the 56-week mark, a staggering 89.3% and 90.1% of participants in the 100 mg and 200 mg maintenance groups respectively maintained their PASI 90 response, far exceeding the withdrawal group outcomes, which stood at 37.7% and 51.7%. This substantial difference highlights the sustained efficacy of quarterly dosing with picankibart when compared to treatment withdrawal. It provides a clear indication that picankibart can deliver lasting benefits for those managing psoriasis long-term.

In addition to meeting the primary endpoint, all secondary endpoints were also achieved. Participants in the maintenance groups displayed significant improvements in markers such as PASI 75, PASI 100 (complete skin clearance), and dermatology life quality index (DLQI) scores. The data clearly illustrates that not only does picankibart support skin clearance, but it also enhances quality of life significantly.

Maintenance Treatment Benefits

Perhaps most noteworthy is picankibart's capacity to reduce relapse risk post-withdrawal. Participants in the maintenance arms maintained their treatment effects far longer compared to those who ceased treatment, demonstrating the disease-modifying properties of this agent. The median efficacy durations were noted as 20.4 weeks and 24.6 weeks following withdrawal, showcasing the prolonged benefits of this novel biologic.

Safety, a primary concern in any pharmacological intervention, was continuously monitored throughout the study. Impressively, picankibart exhibited a consistent safety profile with no new safety concerns arising, echoing the findings from earlier clinical investigations.

Expert Endorsements

Professor Shi Yuling, Principal Investigator, hailed the study as a landmark trial, underscoring the exceptional long-term efficacy and treatment convenience provided by IL-23p19 inhibitors. He expressed optimism regarding the success of picankibart, emphasizing its necessity in chronic condition management. Furthermore, Dr. Lei Qian, Chief RD Officer of General Biomedicine at Innovent, articulated the significance of these results for patients and healthcare providers alike. He noted that PECONDLE® sets a new standard in psoriasis treatment, highlighting its potential to simplify patient regimens in pursuing effective and durable results.

Conclusion

As a chronic, often debilitating condition, psoriasis presents substantial challenges to patients' lives. The introduction of PECONDLE® (picankibart injection) represents a significant advancement in therapeutic options, validating Innovent's commitment to developing high-quality, patient-centric solutions in the biopharmaceutical landscape. With plans for future expansions into other indications such as ulcerative colitis, Innovent is poised to address unmet needs in the treatment of autoimmune conditions. This pivotal Phase 3 trial serves not only as a beacon of hope for patients but also reinforces the position of PECONDLE® as a cornerstone in psoriasis treatment regimens moving forward.