Exogenus Leads €13M EU Initiative to Advance Osteoarthritis Therapy

Exogenus Therapeutics is leading a five-year, €13 million European initiative to advance EXO-101, its investigational candidate for osteoarthritis, towards clinical validation. The project, named ExoCordOA, is funded by the European Union’s Horizon Europe programme and brings together ten organisations to address both the development of a potential disease-modifying osteoarthritis drug (DMOAD) and broader challenges in secretome-based therapeutics.

The consortium’s objectives extend beyond a single candidate. Alongside supporting EXO-101’s planned Phase I and II clinical development, the project aims to strengthen manufacturing consistency, analytical characterisation, potency assessment, quality control and regulatory pathways for extracellular vesicle-enriched secretome therapies.

Osteoarthritis Remains Without Approved Disease-Modifying Drugs

Osteoarthritis is a leading cause of disability worldwide, affecting approximately 8% of the global population, according to the project announcement. Its burden is expected to increase as populations age, with women disproportionately affected.

Current treatment approaches primarily manage symptoms, including pain and impaired joint function. Some patients with advanced disease eventually require joint replacement. The absence of approved disease-modifying osteoarthritis drugs leaves an important therapeutic gap: treatments that could alter disease progression rather than mainly relieve symptoms.

EXO-101 is being developed to address this unmet need. However, its ability to slow osteoarthritis progression, preserve joint structure or improve long-term patient outcomes remains unproven in clinical studies.

EXO-101 Development and the Wider Secretome Platform

EXO-101 is an extracellular-vesicle-enriched secretome candidate derived from umbilical cord blood. Secretomes contain a mixture of biologically active substances released by cells, including proteins, lipids and RNA molecules. Such components may influence inflammatory responses and tissue-repair processes, although their clinical effects depend on the specific product and supporting evidence.

ExoCordOA aims to advance EXO-101 through the development activities needed for clinical evaluation. These include manufacturing development, preclinical safety work and regulatory and clinical activities intended to support Phase I and II studies during the project period.

The announcement does not establish that these clinical trials have already started. Progression will depend on completion of the required development and regulatory steps.

The second objective is to address technical barriers affecting secretome-based medicines more broadly. These complex biological products can be difficult to characterise and manufacture consistently. Standardised production methods, reliable analytical testing and clinically relevant potency assays could help developers establish product quality and biological activity more reproducibly.

The consortium also intends to strengthen quality-control approaches and clarify regulatory expectations. These activities may support future secretome-based therapies, but their value will depend on the methods developed and the evidence generated through their application.

Ten Organisations Form the European Consortium

Coordinated by Exogenus Therapeutics, ExoCordOA includes nine additional organisations: 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.

The partners bring expertise spanning biotechnology, manufacturing, clinical and regulatory development, imaging, academia and healthcare. Their combined capabilities are intended to support EXO-101’s development while addressing the scientific and operational requirements for translating secretome research into clinical applications.

Joana Correia, PhD, co-founder and chief executive officer of Exogenus Therapeutics, said the initiative would combine efforts to advance EXO-101 towards clinical validation with work addressing barriers across the wider secretome therapeutics field.

Clinical Interpretation: Funding Enables Development, Not Validation

The €13 million ExoCordOA initiative represents a substantial European investment in both a potential osteoarthritis treatment and the infrastructure needed to develop secretome-based medicines. Its significance lies in the combination of candidate-specific development with work on manufacturing, analytical and regulatory challenges that may affect the wider field.

Two outcomes will determine the project’s eventual impact. First, EXO-101 must demonstrate an acceptable safety profile and clinically meaningful benefit through appropriately designed studies. Second, the consortium must establish reliable approaches to manufacturing and characterising secretome-based products.

Neither outcome is guaranteed by the funding announcement. EXO-101 remains investigational, and claims that it could prevent joint damage, delay joint replacement or modify osteoarthritis progression require clinical evidence.

For now, ExoCordOA marks progress towards clinical evaluation and more standardised development of secretome therapies. Whether that investment ultimately produces a disease-modifying treatment for osteoarthritis will depend on the evidence generated during the project.

Reference

Exogenus Therapeutics leads a €13 million EU-funded consortium to advance a new secretome-based therapy for osteoarthritis, Exogenus Therapeutics, 29 October 2026