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

Información del proyecto

FENM4PTSD

Identificador del acuerdo de subvención: 101144958

DOI

10.3030/101144958

Proyecto cerrado

Fecha de la firma de la CE 8 Diciembre 2023

Fecha de inicio 1 Mayo 2024

Fecha de finalización 30 Abril 2026

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

€ 3 558 661,25

Aportación de la UE

€ 2 491 062,88

Coordinado por

REST THERAPEUTICS
France

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

Período documentado: 2024-05-01 hasta 2025-04-30

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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.