India Pharma Outlook Team | Thursday, 16 January 2025
Lyndra Therapeutics, a biopharmaceutical company in the clinical stage, has formed a strategic partnership with Thermo Fisher Scientific Inc., wherein Thermo Fisher will offer global clinical research and commercial manufacturing services to Lyndra for its long-acting oral therapies. Lyndra’s extended-release oral treatments, such as the primary investigational product oral weekly risperidone (LYN-005), aim to provide medication for a week or more with just one oral administration.
LYN-005 achieved its main objective in the phase 3 pivotal STARLYNG-1 trial, showing effectiveness against daily Risperdal. The key phase 3 safety trial for oral weekly risperidone is set to commence in the first half of 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 partnership utilizes Thermo Fisher’s Accelerator Drug Development services, 360° Contract Development and Manufacturing Organization (CDMO), and Contract Research Organization (CRO) solutions for drug development.