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Lyndra Therapeutics, a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, has announced a strategic collaboration with Thermo Fisher Scientific Inc., the world leader in serving science, in which Thermo Fisher will provide global clinical research and commercial manufacturing services to Lyndra for its long-acting oral therapies.
Lyndra’s long-acting oral therapies, including lead investigational product oral weekly risperidone (LYN-005), are designed to deliver medication for a week or longer with a single oral dose. LYN-005 met its primary endpoint in the phase 3 pivotal STARLYNG-1 study, demonstrating efficacy compared to daily Risperdal. The phase 3 pivotal safety study of oral weekly risperidone is planned to be initiated in 1H 2025.
The collaboration leverages Thermo Fisher’s Accelerator Drug Development services, 360° Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) drug development solutions. Accelerator Drug Development provides a customisable suite of manufacturing, clinical research and clinical supply chain services for emerging biotechs and large pharmaceutical companies at every stage from pre-clinical to commercialisation.
As part of the collaboration, Lyndra plans to utilise Thermo Fisher’s end-to-end advanced pharmaceutical manufacturing capabilities in Cincinnati, Ohio, US including Lyndra’s LYNX drug delivery platform commercial line, to manufacture commercial materials at scale.
