Lyndra Partners with Thermo Fisher for Long-Acting Oral Therapy Development

Lyndra Therapeutics, a biopharmaceutical company focused on developing long-acting oral therapies, has entered into a significant collaboration with Thermo Fisher Scientific Inc., a global leader in scientific services. This partnership is set to provide Lyndra with global clinical research and manufacturing services, advancing its mission to transform medication delivery.

Lyndra's innovative oral therapies, notably its leading investigational product, oral weekly risperidone (LYN-005), are designed to release medication for a week or longer from a single dose. The promising results from the phase 3 STARLYNG-1 study demonstrated the efficacy of LYN-005 compared to the traditional daily Risperdal regimen. Plans are in place to initiate a pivotal safety study of this weekly risperidone in the first half of 2025.

Dr. Richard Scranton, the President of Global Product Development and Chief Medical Officer at Lyndra Therapeutics, emphasized the importance of this collaboration with Thermo Fisher. He noted that it is a vital step toward revolutionizing medication intake, providing Lyndra with the necessary scale and capabilities to reach wider markets. This partnership will allow Lyndra to concentrate on research and development, ensuring the production and clinical trial operations are robust and scalable.

The collaboration will utilize Thermo Fisher’s Accelerator™ Drug Development services, alongside their comprehensive CDMO and CRO drug development solutions. This service offers a customizable approach to manufacturing, clinical research, and supply chain needs for biotechs and pharmaceutical companies from pre-clinical stages to commercialization.

A key aspect of the collaboration includes the use of Thermo Fisher’s advanced pharmaceutical manufacturing facilities in Cincinnati, Ohio. This facility will be instrumental in the commercial-scale production of Lyndra’s products, leveraging their LYNX drug delivery platform.

Michael Shafer, Executive Vice President and President of Biopharma Services at Thermo Fisher, expressed enthusiasm about collaborating with Lyndra on its innovative drug delivery platform. He underscored Thermo Fisher's commitment to simplifying and accelerating the clinical development journey, which aligns with their comprehensive drug development solutions.

The partnership also holds potential benefits for other pharmaceutical companies interested in Lyndra’s LYNX platform technology. By collaborating with Thermo Fisher, these companies can accelerate their development timelines and support the commercialization of long-acting oral therapies.

The LYNX drug delivery platform is designed to enhance clinical outcomes by optimizing medication delivery. It enables stable and sustained drug delivery for a week or longer with a single dose, a breakthrough made possible by over 50 patented innovations in design and materials science. Originating from the Traverso and Langer Laboratories, the LYNX platform has an exclusive technology license with Lyndra. The platform’s broad potential across various therapeutic areas could significantly impact oral drug delivery, improving the patient experience and adding value to the healthcare system.

Lyndra Therapeutics continues to make strides as a clinical-stage biopharmaceutical company, aiming to commercialize long-acting oral therapies through strategic partnerships. Their LYNX platform, which facilitates less frequent dosing and more consistent drug exposure, has been validated through clinical research in multiple therapeutic areas, showcasing its versatility and potential to enhance patient care.