Drug solution for bone fracture nonunions

Informations projet

OSTEOforUNION

N° de convention de subvention: 101189252

DOI

10.3030/101189252

Date de signature de la CE 11 Decembre 2024

Date de début 1 Janvier 2025

Date de fin 31 Decembre 2026

Financé au titre de

• The European Innovation Council (EIC)

Coût total

Aucune donnée

Contribution de l’UE

€ 2 499 999,00

Coordonné par

GENERA ISTRAZIVANJA DRUSTVO S OGRANICENOM ODGOVORNOSCU ZA PROIZVODNJU BIOTEHNOLOSKIH PROIZVODA
Croatia

Periodic Reporting for period 1 - OSTEOforUNION (Drug solution for bone fracture nonunions)

Période du rapport: 2025-01-01 au 2025-12-31

Résumé du contexte et des objectifs généraux du projet

Bone fracture nonunion (FNU) is a serious medical condition in which a broken bone fails to heal properly. Although only a small percentage of fractures develop into nonunions, the overall burden is high due to the large number of fractures worldwide. Patients with FNUs often suffer from long-term pain, repeated surgeries, reduced mobility, loss of quality of life and prolonged absence from work. Current standard treatments rely mainly on harvesting bone from the patient’s own body, an invasive procedure associated with additional pain, complications and significant healthcare costs. Despite this unmet clinical need, no biological drug is currently approved specifically for the treatment of bone fracture nonunions.
The OSTEOforUNION project addresses this gap by developing and preparing for market entry a novel biological drug, OSTEOGROW-C, designed to stimulate natural bone regeneration. The project is embedded in the broader European policy context of strengthening innovation in healthcare, reducing the burden of chronic conditions, improving patient outcomes, and supporting the competitiveness of European biotechnology companies. By advancing a new regenerative therapy, the project contributes to EU priorities in health innovation, sustainability of healthcare systems and strategic autonomy in advanced medical technologies.
The overall objective of OSTEOforUNION is to complete the late-stage clinical development, regulatory preparation and manufacturing readiness of OSTEOGROW-C so that it will become the first approved biological treatment for bone fracture nonunions. The project pathway to impact is based on efficacy and safety, enabling regulatory approval in Europe and internationally, and preparing the conditions for rapid uptake in clinical practice. At scale, OSTEOGROW-C has the potential to significantly reduce complications, shorten recovery times, lower long-term healthcare, and decrease societal costs associated with non-healing fractures. It might eliminate the need to use patients’ own bones as a therapy for bone FNUs, relieving patients of pain and possible complications linked to bone harvesting.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

The project builds on extensive prior research and development and focuses on the final steps needed to bring OSTEOGROW-C to patients. Core activities include optimization and scaling of the production process for the active biological component recombinant human bone morphogenetic protein 6 (rhBMP6), ensuring consistent quality and compliance with pharmaceutical manufacturing standards (GMP). In parallel, the final configuration of the OSTEOGROW-C kit has been refined to support safe and reproducible use in surgical settings.
A central achievement of the project is the advancement of clinical validation. OSTEOGROW-C has already demonstrated favorable safety and efficacy outcomes in earlier clinical case reports and preclinical studies across several bone indications. OSTEOforUNION pivotal Phase II/III clinical trial for long bone fracture nonunions is under regulatory exploration, clinical sites in the EU, UK and US have been selected and have provided a list of patients with bone FNUs, which will support rapid recruitment. OCEAN clinical study trial is designed to confirm the therapeutic benefit of OSTEOGROW-C and to generate robust data for regulatory submissions and marketing approval.
In parallel, the innovative protocol is under discussion with EMA, MHRA and FDA. The development of quality systems needed for marketing authorization is underway, and strengthening of internal capacities for pharmacovigilance, quality assurance and supply chain readiness is under construction. Together, these activities represent a major step toward transforming a clinically validated innovation into an approved, deployable medical therapy.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

OSTEOforUNION delivers results that go beyond the current state of the art in bone regeneration. OSTEOGROW-C introduces a new therapeutic concept that uses the patient’s own blood as a natural carrier for rhbMP6 and synthetic ceramics transforming blood to bone. This approach eliminates the need for harvesting bone from the patient, reducing surgical trauma and associated risks, while actively stimulating the body’s own bone-forming processes.
The project’s results point to a paradigm shift in how fracture nonunions can be treated: from invasive, resource-intensive procedures toward a personalized, biologically driven solution. When widely adopted, the technology will accelerate bone healing, reduce repeated surgeries and improve functional recovery. Beyond fracture nonunions, the underlying platform opens pathways for future applications in other orthopaedic and dental indications.
For further uptake and long-term success, continued regulatory engagement, market access strategies and partnerships with established healthcare industry actors are essential. The project has laid the groundwork for these next steps, enabling subsequent commercialization, internationalization and integration into routine clinical practice.

Bone fracture nonunion and regeneration outcome in human patient

Small amount of the patient’s blood is combined with a biological growth factor

preparation and application of the personalised implant during a standard orthopaedic procedure