ADCs announced results from the Phase 3 study of BAT2206, a proposed biosimilar referencing Stelara® (ustekinumab). The primary endpoint of this study was improvement from baseline in Psoriasis Area and Severity Index (PASI) score to Week 12, demonstrating BAT2206 is highly similar with Stelara® in patients with moderate to severe plaque psoriasis. In the US, Stelara® is currently approved for the treatment of patients 6 years or older with active psoriatic arthritis (PsA), the treatment of patients 6 years or older with moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn's disease (CD) in adults, and the treatment of moderately to severely active ulcerative colitis (UC) in adults.

The BAT2206 clinical trial was a global, multicenter, randomized, double-blind, parallel-arm, Phase 3 study designed to compare the efficacy, safety, immunogenicity and PK of BAT2206 with Stelara® in 556 patients with moderate to severe plaque psoriasis. More information regarding the BAT2206 Phase 3 clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: https://clinicaltrials.gov/study NCT04728360 Results of the study will be presented in a future medical meeting or publication. Bio-Thera entered into a commercialization and license agreement with Hikma for BAT2206 in August 2021.

Developed by Bio-Thera, BAT2206 will be commercialized by Hikma in the United States of America.