Centessa (CNTA) Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has cleared the IND to initiate a Phase 1 clinical study of ORX142 in healthy volunteers. ORX142 is the second drug candidate from the Company’s multi-asset orexin franchise. “The clearance of our IND to initiate clinical studies of ORX142 represents a significant milestone, signaling the beginning of an exciting new phase in the clinical development of our OX2R agonist pipeline for indications beyond rare hypersomnias,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. “With our most advanced OX2R agonist, ORX750, advancing in the Phase 2a CRYSTAL-1 study for the treatment of narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia, we are eager to leverage our insights from this new drug class and explore ORX142’s potential to treat a broad range of neurological and neurodegenerative disorders with significant unmet needs. We are excited to begin executing our ORX142 Phase 1 clinical study in acutely sleep-deprived healthy volunteers which is aimed at generating early proof-of-concept data for ORX142 this year which we expect to enable a dose selection for planned studies evaluating ORX142 in patients.”
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