The company is preparing to advance its drug candidate for complex perianal fistulas associated with Crohn’s disease into clinical development and aims to achieve first-in-human administration by the end of the first half of 2027.
Strasbourg, September 30, 2026. EVerZom, a French biotechnology company specializing in exosome-based therapies for regenerative medicine, announces that it has reached a major milestone in the development of its drug candidate EVerGel™. The company has successfully completed the CTA-enabling preclinical safety and biodistribution studies for EVerGel™, confirming a favorable profile for further clinical development.
These results enable EVerZom to actively prepare its clinical trial application (CTA), with the goal of achieving first-in-human administration by the end of the first half of 2027.
A key milestone in preparing the clinical trial application
Biodistribution and toxicity studies are a critical step in the development of innovative biological therapies. They are designed to characterize the distribution of the product throughout the body and assess its safety profile.
The results obtained in two animal species demonstrate a favorable safety profile for administration in humans. These data strengthen the robustness of the EVerGel™ candidate and support the company’s clinical development strategy.
“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,” said Jeanne Volatron, Co-Founder and CEO of EVerZom.
“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,” said 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.
Towards a first clinical study in Crohn’s perianal fistulas
EVerZom is preparing its clinical trial application for EVerGel™ in complex perianal fistulas associated with Crohn’s disease. Data from the CTA-enabling preclinical studies will complete this application and support discussions with regulatory authorities.
The development of EVerGel™ aims to expand treatment options for patients living with this debilitating complication of Crohn’s disease.
EVerGel™ is based on a differentiated approach combining:
- Exosomes derived from mesenchymal stem cells (MSCs),
- A biocompatible hydrogel designed to promote their local retention.
This formulation is being developed to promote tissue healing at the fistula site.
Next steps
The next steps include finalizing the clinical trial application and engaging with regulatory authorities.
The company aims to achieve first-in-human administration by the end of the first half of 2027, subject to obtaining the required approvals.
In parallel, the company continues to develop its pipeline across several therapeutic areas and is in discussions with various partners to launch joint therapeutic programs.
Press contact: Florence Portejoie, FP2COM, +33 6 07 76 82 83, fportejoie@fp2com.fr
About EVerZom
EVerZom develops a proprietary bioproduction platform and therapeutic candidates based on mesenchymal stem cell-derived exosomes. Its strategy involves combining exosomes with biomaterials for therapeutic applications. Its pipeline includes EVerGel™, which is being developed for complex perianal fistulas associated with Crohn’s disease and is being prepared for clinical development, as well as other programs in regenerative medicine, hepatology and ophthalmology.
In 2025, EVerZom raised €10 million 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.
Since its founding in 2019, EVerZom has established itself as an innovator in the exosome field, with a platform spanning the entire value chain, from production to formulation.
For more information: https://everzom.com
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