ELIQUENT Life Sciences 加入 1300 万欧元 Horizon Europe 联盟，推进新型骨关节炎疗法监管开发

ELIQUENT will contribute regulatory development expertise to ExoCordOA, a five-year European program advancing secretome-based therapeutics toward clinical use

, /PRNewswire/ -- ELIQUENT Life Sciences, a global regulatory, quality and safety consulting firm, today announced its participation in ExoCordOA, a €13 million, five-year project funded by Horizon Europe and coordinated by Exogenus Therapeutics. The program is focused on advancing extracellular vesicle-enriched secretome therapies toward clinical use, initially in osteoarthritis.

ExoCordOA brings together ten organizations with complementary expertise spanning biotechnology, clinical and regulatory development, GMP manufacturing, academia and healthcare. ELIQUENT Life Sciences will contribute regulatory development expertise to the consortium, supporting a collaborative effort designed to advance an emerging therapeutic approach from innovative science toward clinical validation.

A central objective of the program is to advance Exogenus Therapeutics' lead candidate, EXO-101, toward clinical validation as a potential disease-modifying treatment for osteoarthritis. The program is intended to support Phase I and II clinical development while addressing scientific, manufacturing, quality-control and regulatory challenges that currently affect the clinical translation of extracellular vesicle and secretome therapies.

The consortium also aims to contribute to more standardized approaches, robust analytical and potency-assessment methods, and a clearer regulatory pathway for future secretome-based medicines.

"ExoCordOA represents the type of innovative development program where regulatory strategy needs to evolve alongside the science," said Dr Ivan Fisher, Head of Regulatory Affairs, UK and Europe at ELIQUENT Life Sciences. "ELIQUENT is proud to contribute our regulatory development expertise to this multidisciplinary European collaboration as we work together to address some of the challenges associated with bringing an emerging therapeutic approach toward the clinic. By considering regulatory requirements and engaging regulatory agencies early in development, we can help define the regulatory framework for what is a cutting-edge program, providing the momentum needed to translate innovative science into potential new therapies for patients."

ELIQUENT's role in ExoCordOA reflects the importance of incorporating regulatory thinking early in development as teams navigate increasingly complex pathways from scientific innovation toward clinical development. ELIQUENT's current brand narrative positions regulatory strategy as one element in maintaining progress across the product lifecycle, with integrated expertise spanning regulatory affairs, quality and compliance, and pharmacovigilance and safety.

Joana Correia, PhD, Co-Founder and Chief Executive Officer of Exogenus Therapeutics, said in the consortium announcement:

"ExoCordOA brings together the expertise needed not only to advance EXO-101 towards clinical validation in osteoarthritis, but also to tackle barriers affecting the wider secretome therapeutics field. As project coordinator, Exogenus is proud to lead this collaborative European effort to establish stronger scientific, manufacturing and regulatory foundations for a new generation of regenerative medicines."

The ExoCordOA consortium is coordinated by Exogenus Therapeutics and comprises: Lonza, Anthony Nolan, ELIQUENT Life Sciences, iLoF - Intelligent Lab on Fiber, Utrecht University, University Medical Center Utrecht, Maastricht University Medical Center+, Image Analysis Group and ReumaNederland.

According to the consortium announcement, osteoarthritis affects approximately 8% of the global population and there are currently no approved disease-modifying osteoarthritis drugs. EXO-101 is being developed as a potential disease-modifying treatment for osteoarthritis.

About ELIQUENT Life Sciences

ELIQUENT Life Sciences brings together expertise across regulatory affairs, quality and compliance, and pharmacovigilance and safety to help life sciences organizations navigate complexity throughout the product lifecycle. ELIQUENT's current go-to-market narrative emphasizes an integrated global team that combines strategic guidance with execution to help programs maintain momentum from development through commercialization.

Momentum Starts Here. 

For more information, visit ELIQUENT.com

SOURCE ELIQUENT Life Sciences