Century Therapeutics Announces IND Application Clearance For CNTY-101

(RTTNews) - Century Therapeutics (IPSC) announced the company has been notified by the FDA that the Phase 1 clinical trial may proceed to assess CNTY-101 in patients with moderate to severe systemic lupus erythematosus who have failed at least two standard immunosuppressive therapies. The company said this represents the first IND application clearance for an autoimmune and inflammatory disease indication for CNTY-101.

The multi-center Phase 1 clinical trial is designed to assess the safety, tolerability, pharmacokinetics, and clinical response of CNTY-101. The trial will evaluate one to two cycles of 3 weekly doses of CNTY-101. The company plans to initiate the trial in the first half of 2024, with initial data expected by the end of 2024.

Shares of Century Therapeutics are up 8% in pre-market trade on Wednesday.

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