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Lyndra Therapeutics Announces Positive Outcome...

Meeting with the FDA for Lyndra's Weekly Risperidone (LYN-005) for the Treatment of Adults with Schizophrenia and Other Indications. FDA and Lyndra align on proposed pivotal trial program, including a PK comparability study and 6-month, double-blind safety study.

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.

“We are grateful to the FDA for their guidance as we design this pivotal program. Transforming the patient experience via oral therapies that achieve consistent plasma drug concentrations at target therapeutic levels for an entire week is one of our key goals,” said Dr. Patricia Hurter, Chief Executive Officer of Lyndra Therapeutics. “This pivotal program allows us to deliver swiftly on the unmet need for ultra-long-acting oral therapies that have the potential to have an enormous and positive impact for patients and caregivers. We hope that the availability of an oral, once-weekly risperidone product will provide a valuable option for those who struggle with adherence but prefer an oral formulation.”

The June EOP2 meeting was attended by FDA staff from the Center for Drug Evaluation and Research, including the Emerging Technology Team, and the divisions of Psychiatry, Pharmacology and Toxicology for Neuroscience, and Regulatory Operations for Neuroscience.

“The FDA provided valuable feedback during the end-of-phase 2 meeting on trial design, manufacturing and control strategy and Lyndra’s path forward as we pursue the pivotal program,” said Dr. Richard Scranton, Chief Medical Officer of Lyndra Therapeutics. “The productive and collaborative nature of these meetings has allowed us to develop a clear and direct course of action as we pursue the tremendous potential of LYN-005.”

Advancement of LYN-005 into pivotal trials and the company’s preparation for commercialization in the U.S. are enabled by the recent closing of Lyndra’s $60.5 million Series C financing. The round was led by new investor AIG Investments, an affiliate of American International Group, Inc. Since inception, Lyndra has received $240 million in funding, inclusive of this round.

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