Clinical trials
The value of an idea lies in the using of it ~ Thomas Edison
Clinical development
After completing the preclinical validation phase, REMAST therapy enters in the clinical path.
Hemera’s goal is to start the Clinical Trial within 2027.
To this end, Hemera’s scientists will work to address two main fronts: the production of the cell therapy according to the high pharmaceutical quality standards and the approval of protocols for the first applications of the therapy in humans.
2023
In 2023, a prospective observational study of patients with complete traumatic spinal cord injury began..
The aim of the study is to monitor the clinical trend of motor, sensory and physiological functions in spinal cord-injured patients, starting from the acute post-traumatic phase, and to validate the criteria for inclusion of patients in the subsequent interventional study.
2024-2025
The team works on defining the production protocols for Hemera’s advanced cell therapy at a pharmaceutical-grade level, in accordance with standardized criteria of safety, quality, efficacy, and reproducibility required by Regulatory Agencies for the clinical use of drugs in humans. This will enable us to obtain the necessary authorizations to launch the multicenter Phase 1–2 first-in-human clinical trial at selected centers of excellence in Italy and Europe.
At the same time, the team is actively developing the REMaST platform for new applications in the field of regenerative medicine.
2026-2027
Hemera completes the key regulatory documentation required to start the REMaST® clinical trial. This includes the Investigator’s Brochure (IB), the Investigational Medicinal Product Dossier (IMPD), and the interventional clinical protocol, consolidating preclinical, safety, and GMP manufacturing data.
Building on the Orphan Drug Designation granted by the EMA, Hemera strengthens its engagement with European regulatory authorities through targeted Scientific Advice into an early and continuous dialogue to optimize the clinical development strategy, align on product and protocol requirements, and benefit from accelerated regulatory pathways for innovative therapies addressing high unmet medical needs.
Hemera actively engages in developing an international clinical network with centers of excellence for the treatment of spinal cord injuries, and in developing a customized catheter-based delivery system.
Phase 1 of the clinical trial begins in collaboration with the selected CRO
which oversees patient monitoring and efficacy data collection over 12 months period. The trial, conducted at Niguarda Hospital in Milan, involves an initial group of 6 patients, leveraging the Orphan Drug Designation obtained in 2023.
The goal of the first-in-human interventional clinical trial is to demonstrate the safety and efficacy of the REMaST® therapy, while defining the optimal dose and route of administration.
If results are positive, Hemera may gain access to the EMA’s accelerated approval pathway (PRIority MEdicines – PRIME Programme) and will work on defining the pricing and market access strategy in coordination with national and international regulatory authorities.
2028-2029
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