Lyndra Therapeutics, a clinical-stage biopharmaceutical company pioneering long-acting oral therapies, has entered a strategic collaboration with Thermo Fisher Scientific, 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.
“Lyndra’s clinical research and manufacturing collaboration with Thermo Fisher is a critical step in our mission to transform how patients take medicine, providing the capabilities and scale to bring long-acting oral therapies to broad markets,” said Dr. Richard Scranton, M.D., M.P.H., President of Global Product Development and Chief Medical Officer of Lyndra Therapeutics. “Thermo Fisher will be part of our ecosystem of best-in-class partners as we execute on our go-to-market strategy, allowing Lyndra to focus on what we do best – R&D for innovative long-acting oral therapeutic solutions – while ensuring reliable, scalable manufacturing and clinical trial operations.”
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 customizable suite of manufacturing, clinical research and clinical supply chain services for emerging biotechs and large pharmaceutical companies at every stage from pre-clinical to commercialization.
As part of the collaboration, Lyndra plans to utilize Thermo Fisher’s end-to-end advanced pharmaceutical manufacturing capabilities in Cincinnati, Ohio, including Lyndra’s LYNX drug delivery platform commercial line, to manufacture commercial materials at scale.
“Thermo Fisher is pleased to collaborate with Lyndra on its revolutionary drug delivery platform, and we look forward to helping bring these groundbreaking, long-acting oral therapies to patients,” said Michael Shafer, Executive Vice President and President, Biopharma Services at Thermo Fisher. “Leveraging Accelerator™ Drug Development, our comprehensive CDMO and CRO drug development solutions, exemplifies our commitment to help speed and simplify the complex journey of clinical development.”
