EVerZom completes preclinical studies needed to support clinical trial application for Crohn’s fistula candidate
EVerZom, a French biotechnology company specialising in exosome-based therapies for regenerative medicine, has completed the preclinical safety and biodistribution studies needed to support a clinical trial application (CTA) for its drug candidate EVerGel™. The company says the results confirm a favourable profile for further clinical development, and it aims to achieve first-in-human administration by the end of the first half of 2027, subject to obtaining the required approvals.
Safety and biodistribution data
Biodistribution and toxicity studies are a critical step in the development of innovative biological therapies. They are designed to characterise how a product is distributed throughout the body and to assess its safety profile. According to EVerZom, results obtained in two animal species demonstrate a favourable safety profile for administration in humans. The data will complete the CTA and support discussions with regulatory authorities.
Jeanne Volatron, Co-Founder and CEO of EVerZom, said: “The successful completion of these CTA-enabling preclinical studies represents a pivotal milestone for the company’s entire pipeline. The results validate not only the safety of EVerGel™ but also the relevance of our technology platform. We are now fully focused on preparing for clinical development, with the ambition of rapidly bringing a solution to patients living with severe conditions.”
A first target in Crohn’s perianal fistulas
EVerGel is being developed for complex perianal fistulas associated with Crohn’s disease. It combines exosomes derived from mesenchymal stem cells (MSCs) with a biocompatible hydrogel designed to promote their local retention, and the formulation is intended to promote tissue healing at the fistula site. The company says the development aims to expand treatment options for patients living with this debilitating complication of Crohn’s disease.
Prof Damián García-Olmo, MD, PhD, Head of the Department of Surgery at Fundación Jiménez Díaz University Hospital in Madrid, a pioneer in regenerative medicine and mesenchymal stem cells and an expert in complex perianal fistulas associated with Crohn’s disease, commented: “Complex perianal fistulas associated with Crohn’s disease remain difficult to manage. These nonclinical studies are a preliminary step toward evaluating EVerGel™ in patients. Clinical studies will be needed to assess its safety and explore its therapeutic potential in this indication.”
Next steps and company background
The next steps include finalising the CTA and engaging with regulatory authorities. In parallel, EVerZom continues to develop its pipeline across several therapeutic areas and is in discussions with various partners to launch joint therapeutic programmes.
EVerZom develops a proprietary bioproduction platform and therapeutic candidates based on mesenchymal stem cell-derived exosomes, combining them with biomaterials. Besides EVerGel, its pipeline includes programmes in regenerative medicine, hepatology and ophthalmology. Founded in 2019, the company raised €10 million in 2025 from Capital Grand Est, the EIC Fund, Sorbonne Venture by Audacia, Aloe Private Equity, Paris Business Angels, Capital Cell and several family offices, to accelerate the clinical and industrial development of its platform.
For more information, visit: https://everzom.com