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
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.
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.
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.