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The US Department of Defense has awarded a collaborative grant to Transcend Therapeutics and Yale University (US).

The grant is to fund the preclinical research of Transcend’s lead candidate, methylone for treating post-traumatic stress disorder (PTSD). The funding builds on Yale University’s $1m Department of Defense (DoD) grant to study the mechanism of action of methylone and midomafetamine (MDMA) in PTSD.

Methylone (TSND-201) is a rapid-acting neuroplastogen (a biological substrate not a therapeutic).

Transcend is conducting a placebo-controlled Phase I/II trial (NCT05741710) in the UK to evaluate the safety and efficacy of methylone in treating patients with severe PTSD.

Part A of the study was an open-label study and was expected to enrol up to 15 participants with PTSD. Top-line data from this part is expected by the end of this year. Part B of the trial will be a randomised, double-blind, placebo-controlled study enrolling up to 64 patients.

Transcend’s co-founder and medical adviser for the US Department of Veterans Affairs National Center for PTSD stated: “There is a tremendous demand, especially among veterans, for new and effective treatments for PTSD.”

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Multiple PTSD treatments currently in development include Halucenex’s synthetic psilocybin, which showed a 40% reduction in PTSD symptoms in the Phase II trial. Bionomics is expected to announce the Phase IIb trial (NCT04951076) results for BNC210 in Q3 2023. BNC210 is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor and has received a fast track designation from the Food and Drug Administration (FDA) for treating PTSD.

The US DoD has also sponsored a PTSD Phase II trial (NCT05422612) for the combination therapy of Idorsia Pharmaceuticals’ Quviviq (daridorexant), fluoxetine and vilazodone hydrochloride.