Lyndra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for Lyndra’s Weekly Risperidone (LYN-005) for the Treatment of Adults with Schizophrenia and Other Indications

Excerpt from the Press Release:

WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005), the company’s lead product candidate for once-weekly treatment of schizophrenia. The company plans to initiate its pivotal program for LYN-005, designed as the first-ever oral, ultra-long-acting, extended-release therapy, in early 2022.

Lyndra and the FDA aligned on key elements of Lyndra’s pivotal program: a ~90-person pharmacokinetic (PK) comparability study that bridges to the previously established safety and efficacy of risperidone and a double-blind safety study of 6 months’ duration to characterize the safety profile of the Lyndra dosage form. Both studies will evaluate LYN-005 at weekly doses ranging from 2 to 6 mg risperidone daily. These studies will support indications in schizophrenia, bipolar mania, and bipolar 1 disorder.

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