Biopharmaceutical company Lyndra Therapeutics has entered into a clinical research and commercial manufacturing services collaboration with Thermo Fisher Scientific to advance its long-acting oral therapies.
Under the partnership, Thermo Fisher will provide global clinical research and manufacturing services for these Lyndra’s treatments.
Lyndra’s long-acting oral therapies, such as the lead experimental product LYN-005 (oral weekly risperidone), are designed to provide medication for a week or more with just one oral dose.
In the Phase 3 STARLYNG-1 study, LYN-005 met the primary endpoint, showing efficacy over daily Risperdal. The Phase 3 safety study for LYN-005 is set to begin in the first half of this year.
Lyndra chief medical officer and global product development president Richard Scranton said: “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.
“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 taps into Thermo Fisher’s Accelerator Drug Development services, combining 360° contract development and manufacturing organisation (CDMO) and contract research organisation (CRO) drug development solutions.
Accelerator Drug Development offers customisable manufacturing, clinical research, and clinical supply chain services for biotechs and pharmaceutical companies from pre-clinical through commercialisation.
As part of the partnership, Lyndra will use the advanced manufacturing capabilities of Thermo Fisher in Cincinnati, Ohio, including the LYNX drug delivery platform commercial line, to scale up commercial material production.
Thermo Fisher executive vice president and biopharma services president Michael Shafer said: “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.
“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.”
