Lyndra, Thermo Fisher team on research and manufacturing of long-acting oral therapies

Lyndra Therapeutics has partnered with Thermo Fisher Scientific to support the development and manufacturing of its long-acting oral therapies. 

The collaboration includes clinical research services for a Phase 3 pivotal safety study of Lyndra’s weekly oral risperidone (LYN-005), scheduled to begin in the first half of 2025, as well as commercial-scale manufacturing using Lyndra’s LYNX drug delivery platform.

The LYNX platform is designed to provide a week or longer of drug delivery with a single oral dose. LYN-005 has already demonstrated efficacy in Lyndra’s STARLYNG-1 study, meeting its primary endpoint compared to daily Risperdal. Thermo Fisher will provide end-to-end manufacturing support through its Cincinnati, Ohio, facility, preparing for the potential commercialization of Lyndra’s long-acting therapies.

Thermo Fisher’s role in the partnership includes its Accelerator Drug Development services, which combine clinical research and manufacturing solutions. This approach is expected to streamline Lyndra’s path to market while maintaining focus on the development of its therapies. 

The agreement also positions Lyndra to expand its work with other pharmaceutical companies interested in its LYNX platform technology. The drug delivery system, developed with more than 50 patented innovations, is being explored for use across multiple therapeutic areas, according to the announcement.

“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,” Richard Scranton, president of global product development and chief medical officer at Lyndra Therapeutics, said in a statement.