Lyndra Therapeutics has announced a strategic collaboration with Thermo Fisher Scientific to develop and commercialize Lyndra's long-acting oral therapies. This partnership aims to leverage Thermo Fisher's global capabilities in clinical research and manufacturing to bring innovative treatments to patients.
Collaboration Details
Under the agreement, Thermo Fisher will provide comprehensive services to Lyndra, including support for clinical trials and commercial manufacturing. This collaboration will support the development of Lyndra's portfolio of long-acting oral therapies, including its lead investigational product, oral weekly risperidone (LYN-005).
LYN-005 and Clinical Progress
LYN-005 is designed to deliver medication for a week or longer with a single oral dose. In the Phase III pivotal STARLYNG-1 study, LYN-005 met its primary endpoint, demonstrating efficacy compared to daily Risperdal. A Phase III pivotal safety study of oral weekly risperidone is planned to be initiated in the first half of 2025.
Strategic Implications
"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. He added that Thermo Fisher will be part of their ecosystem of best-in-class partners, allowing Lyndra to focus on R&D for innovative long-acting oral therapeutic solutions while ensuring reliable manufacturing and clinical trial operations.
Thermo Fisher's Role
The collaboration leverages Thermo Fisher’s Accelerator Drug Development services, which include a customizable suite of manufacturing, clinical research, and clinical supply chain services. 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.
LYNX Drug Delivery Platform
The LYNX drug delivery platform enables the stable and sustained delivery of medicine in a target therapeutic window for a week or longer in a single oral dose. The technology originated in the Traverso and Langer Laboratories at MIT, with which Lyndra has an exclusive technology license. This platform has broad applicability across multiple therapeutic areas and the potential to revolutionize oral drug delivery.
