Pecondle gets China approval for psoriasis

[Fred]

Pecondle a monoclonal antibody targets the IL-23p19 subunit, preventing IL-23 from binding to cell surface receptors and has the potential to offer a more effective treatment option for patients with psoriasis.

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PECONDLE® (picankibart injection) has received approval from China's National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy.
 
PECONDLE® is the world's first IL-23p19 antibody whose registrational Phase 3 clinical trial met its primary endpoint with over 80% of subjects achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at Week 16.
   
Among comparable biologics, PECONDLE® offers the longest dosing interval during the maintenance period (once every 12 weeks). It is poised to provide Chinese patients with moderate-to-severe plaque psoriasis comprehensive benefits, including significant skin clearance, improved quality of life, and enhanced dosing convenience.

This approval was based on a pivotal registrational Phase 3 clinical trial, CLEAR-1 (NCT05645627), which evaluated the efficacy and safety of picankibart in Chinese participants with moderate-to-severe plaque psoriasis. The study results showed that:

• At week 16, the proportion of participants achieving PASI 90 (80.3%) and sPGA 0/1 (93.5%) was significantly higher in the picankibart group than in the placebo group (2.0% and 13.1%, p < 0.0001 for both);
  
  
• At week 52, the proportions of participants achieving PASI 90 and sPGA 0/1 in the picankibart 100 mg and 200 mg q12w maintenance treatment groups were stable and maintained at a high level;
  
  
• The proportion of participants who achieved PASI 75, PASI 100, sPGA 0, and DLQI 0/1 was significantly higher in the picankibart group than in the placebo group (p < 0.0001), and picankibart showed varying degrees of improvement in psoriasis in special areas (scalp, nail, palmoplantar and perineal);
  
  
• The overall safety of picankibart was favorable. The most common adverse events (AEs) was upper respiratory tract infection, which was consistent with the safety profile of other IL-23p19 agents. No new safety signals were identified.
  

Source: innoventbio.com