Development of a novel class of therapeutics for PTSD treatment and other neurodegenerative disorders

Project Information

FENM4PTSD

Grant agreement ID: 101144958

DOI

10.3030/101144958

Project closed

EC signature date 8 December 2023

Start date 1 May 2024

End date 30 April 2026

Funded under

• The European Innovation Council (EIC)

Total cost

€ 3 558 661,25

EU contribution

€ 2 491 062,88

Coordinated by

REST THERAPEUTICS
France

Periodic Reporting for period 1 - FENM4PTSD (Development of a novel class of therapeutics for PTSD treatment and other neurodegenerative disorders)

Reporting period: 2024-05-01 to 2025-04-30

Summary of the context and overall objectives of the project

ReST Therapeutics is developing therapies to address significant unmet medical needs in neuropsychiatry and neurodegeneration. We are advancing our lead program, FENM (RST-01), for early treatment of Post Traumatic Stress Disorder (PTSD). We believe FENM (RST-01), when taken in the weeks and months following a traumatic event (the 1st year of PTSD), can help restore the brain’s normal memorization process, normalize stress, and prevent the long-lasting, debilitating effects of PTSD. Once approved, FENM (RST-01) can completely change the existing treatment paradigm for patients and PTSD.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Following the completion of our extensive nonclinical testing, ReST has engaged in discussions with the appropriate regulatory bodies and established a clear path to enter the clinic with FENM (RST-01). ReST intends on submitting an IND with the FDA in Q4 2025. Through the partnership with our CDMO, quality testing has also been completed showing superior stability of our clinical product at 24 months, while strongly improving the industrial scalability and COGS reduction. Our scientific team has continued its research to screen for new applications of FENM (RST-01) and therapeutic indications, particularly targeting more advanced forms of PTSD. As a result of these tests, ReST will now apply for new patents and IP expansion. ReST has also formed a joint lab and partnership to advance the study of PTSD with the CNRS. The work of this lab, a collaboration between industry and academia, will allow or expanded research in the disorder as well as other related diseases.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Throughout our nonclinical testing, FENM (RST-01) has demonstrated superiority and outperformed similar molecules in its class of NMDAR Antagonists (e.g. Memantine, Ketamine). It showed significance in reducing fear, anxiety and depression. Additionally, these results were observed without also observing common side effects such as dissociation and somnolence, typical of the other; less specific, NMDAR Antagonists. There are currently no existing therapies for the early intervention of PTSD and FENM (RST-01) has the potential to be the first in class for this indication.