Contract notification: the regulatory toxicology study will be carried out by C.RIS Pharma
September 10, 2025
C.RIS Pharma, a Contract Research Organisation (CRO) located in Saint-Malo, has been selected to conduct the preclinical regulatory toxicology study described below. Final details of the study are being finalized to start the dose escalation in January 2026.
Publication of the regulatory toxicology Call for Offers
February 18, 2025
A regulatory preclinical toxicology study aimed at assessing the overall effects of HEPHA-440 on the organs will be entrusted to a specialized company certified in Good Laboratory Practices (GLP). This study will be conducted in rabbits, whose sensitivity to LPS is similar to that of humans. It will include two phases:
- A dose-escalation study
- A detailed analysis of acute and long-term toxicity in both males and females, in accordance with GLP standards.
The design has been approved by the French National Agency for Medicines and Health Products Safety (ANSM). The results of these experiments will be crucial to ensuring safe administration in humans and obtaining approval from health authorities. The call for offers has been published on the French government procurement platform (PLACE) and will remain open for one month.
Annual Scientific Meeting
February 17, 2025
At the media library of the Rockefeller Faculty in Lyon, the first annual scientific day of the SyStInn RHU project was held. This event brought together all the teams involved, representatives of partner institutions, and ANR members in charge of monitoring. The progress made in each work package was presented, along with the upcoming steps. This moment was also an opportunity to discuss the challenges encountered and the future directions of the project.
Signature of the Consortium Agreement
December 3, 2024
A Consortium Agreement has been approved and signed by the four partner institutions of the project (UCBL, HEPHAISTOS-Pharma, HCL and CLB), and submitted to the funding organization, the ANR. This document defines the rules of collaboration and specifies the rights and obligations of each party, particularly regarding intellectual property.
Kick-off Meeting
April 24, 2024
The scientific teams, representatives from partner institutions, and ANR members responsible for monitoring the SyStInn RHU gathered to review the project’s objectives and agree on the provisional timeline for the next five years.
