Press Release

Transcend Therapeutics announces publication of new preclinical data demonstrating TSND-201 (methylone) is a rapid-acting neuroplastogen with fewer off-target effects than MDMA

BDNF and other mediators of neuroplasticity increased by 60% 8-hours after dose.

Data support high target selectivity and no hallucinogenic effects.

Growing body of preclinical and clinical data suggests TSND-201 could offer a rapid-acting, durable alternative to existing PTSD treatments.

NEW YORK, Feb. 20 – Transcend Therapeutics, a biotechnology company that develops medicines to treat neuropsychiatric diseases, today announced the publication of new preclinical data supporting the neuroplastic effects of TSND-201 (methylone) in Frontiers in Neuroscience. The study investigated whether TSND-201 induced factors that drive neuroplasticity in key brain areas linked to post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). It also compared effects of TSND-201 with MDMA to explore similarities and differences in their pharmacological effects. MDMA was chosen as a comparison because TSND-201 is a structural analog of MDMA and because MDMA-assisted psychotherapy has recently shown benefit in clinical trials for PTSD.

The results show that neuroplasticity, or how the brain adapts to new learning, underlies the activity of TSND-201. The rapid induction of neurotrophic factors and accompanying neuroplastic changes are a key mechanism for rapid-acting therapeutics. TSND-201 increased brain-derived neurotrophic factor (BDNF) and other mediators of neuroplasticity by ~60% in the frontal cortex 8 hours after dosing. Factors that regulate nerve conduction, another type of neuroplasticity, were also regulated in the amygdala on a similar timescale. TSND-201 effects were highly selective, demonstrated by no off-target receptor activity. This included no activity at 5HT2A receptors, corresponding to a lack of hallucinogenic effects observed in humans and animal models.

“These data support the growing body of evidence for TSND-201 as a potential best-in-class medication for various CNS disorders,” said Transcend Therapeutics Co-Founder and CEO Blake Mandell. “This enhances our understanding of the recently presented clinical data from an open-label Phase 2 clinical trial with rapid, robust, and durable therapeutic effects in patients with severe PTSD.”

“The results suggest that TSND-201 is capable of rapidly inducing unique and targeted neuroplastic changes within the brain,” said Gerard Sanacora M.D., Ph.D. and Co-Director of the Yale New Haven Hospital Interventional Psychiatry Service. “Paired with the encouraging clinical data from Part A of the IMPACT-1 study, TSND-201 offers true promise as an effective treatment relevant to multiple psychiatric indications.”

PTSD is a highly prevalent psychiatric disorder that can become chronic and debilitating when left untreated. Available pharmacotherapies to treat PTSD are limited, with modest efficacy, and can take weeks to months to provide benefit. TSND-201 is currently in clinical development for the treatment of PTSD.

In December 2023, Transcend announced positive open-label data from an ongoing phase 2 clinical trial evaluating TSND-201 as a treatment for PTSD. Previously published preclinical studies show rapid, robust and long-lasting antidepressant-like and anxiolytic effects.

The full study results are available in Frontiers in Neuroscience.