Connect Biopharma Sees CBP-201 Topline Data From China Atopic Dermatitis Trial This Year

The Center for Drug Evaluation of the National Medical Products Administration in China has signed off Connect Biopharma Holdings Limited's CNTB primary analysis of its ongoing pivotal trial for its lead product candidate CBP-201 in atopic dermatitis.
The company will analyze data from the Stage 1 16-week treatment period based on CBP-201 on 255 patients. As a result, Connect Biopharma plans to report this trial's top-line results by year-end, earlier than initially planned.
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"We plan to use the results from this PRC-specific trial, if positive, to initiate pre-NDA discussions with the CDE. Pending the positive outcome of those discussions, we would be on track to file a New Drug Application (NDA) in 2024 after completion and analysis of the Stage 2 36-week treatment period, with a potential NDA approval in China as soon as 2025," said Zheng Wei, Co-Founder & CEO of Connect Biopharma.
In addition, the projected timeline of the company's global Phase 3 program in moderate-to-severe AD remains unchanged, including enrolling the first patient by the end of 2022.
Price Action: CNTB shares are up 1.35% at $0.90 during the premarket session on the last check Tuesday.