Press Release

Transcend Therapeutics Presents New Data At ASCP Demonstrating Improvements In Functioning And Sleep-Related Symptoms in PTSD Patients Treated with TSND-201 (Methylone)

New clinical data demonstrates meaningful functional and global improvements as well as improvement in sleep-related outcomes

Preclinical and clinical data demonstrate transdiagnostic benefit for PTSD, depression and anxiety symptoms

Randomized, placebo-controlled study with TSND-201 is underway

NEW YORK, May 30, 2024 – Transcend Therapeutics, a clinical-stage biotechnology company developing rapid-acting treatments for neuropsychiatric diseases, this week presented three posters at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami Beach, FL, highlighting the the promise of TSND-201 (methylone).

“Sleep and functional impairments are a significant burden for PTSD patients. These open-label data continue to support the efficacy of methylone as a treatment for PTSD and build upon our previously released data from the open-label portion of the IMPACT-1 study,” said Blake Mandell, Co-founder and Chief Executive Officer of Transcend Therapeutics. “We look forward to continuing our randomized placebo-controlled IMPACT-1 study to better characterize the impact of methylone on improving sleep and functioning.”

Summary of poster presentations:

TSND-201 for the Treatment for PTSD: Functional and Global Improvements from the Open-Label Portion of the IMPACT-1 Study (T36)

  • TSND-201 provided meaningful improvements on functioning and global measures of change.
  • Overall and across each domain of the Sheehan Disability Scale (SDS), TSND-201 demonstrated rapid and robust improvements in functioning.
  • Improvement in functioning was consistent with the clinician-rated global improvements.

TSND-201 for the Treatment for PTSD: Improvement in Sleep-Related Outcomes from the Open-label Portion of the IMPACT-1 Study (W45)

  • Participants treated with TSND-201 had a positive impact on sleep.
    TSND-201 showed improvements on the sleep-specific items of the Clinician Administered PTSD Scale for PTSD (CAPS-5), in addition to the total severity score.
  • Similarly, improvements on the sleep item of the Montgomery-Asberg Depression Rating Scale (MADRS) were improved after treatment with TSND-201.
  • Improvements in sleep were also consistently improved on the Pittsburgh Sleep Quality Index (PSQI), a general measure of overall sleep.

TSND-201, a rapid-acting treatment for PTSD and other Central Nervous System (CNS) disorders (T89)

  • Preclinical evidence for TSND-201’s efficacy in behaviors associated with PTSD, depression and anxiety.
  • Parallel clinical results from IMPACT-1 Part A demonstrate TSND-201’s rapid, robust, and long-lasting effects on PTSD, depression and anxiety symptoms.
  • Results support development of TSND-201 to treat multiple CNS disorders.

About TSND-201 

TSND-201, a rapid-acting neuroplastogen, is a proprietary formulation of methylone developed by Transcend Therapeutics. TSND-201 has well-characterized primary pharmacology, with its primary site of action at the monoamine transporters, and no activity at 5HT-2a (i.e., not hallucinogenic). Transcend is developing TSND-201 as a rapid-acting and durable treatment for PTSD, major depressive disorder (MDD), and anxiety indications.

About IMPACT-1

IMPACT-1 (Investigation of Methylone for Post-Traumatic Stress Disorder) is a 2-part trial evaluating the safety and efficacy of TSND-201 for the treatment of PTSD. Part A is open-label (positive results announced in December 2023); Part B (currently enrolling) is randomized, double-blind, and placebo-controlled. Eligible participants are adults with a confirmed diagnosis of PTSD using the DSM-5 criteria and a CAPS-5 total severity score of ≥35. Study drug is dosed once a week for 4 weeks. During each of the 4 dosing sessions, participants are accompanied by a trained mentor who provides non-directive psychological support. After the 4-week treatment period, participants attend follow-up visits at 1, 2, 3, and 6 weeks following the last dose.

About Transcend 

Transcend Therapeutics, founded in 2021, is a clinical-stage, neuroscience-focused company developing rapid-acting treatments for neuropsychiatric diseases. The company’s mission is to develop new drugs for the millions of people for whom current psychiatric medicines have not worked. Transcend’s leadership team has made pivotal contributions to 13 FDA approvals and $7B in M&A and public company value. As a Public Benefit Corporation, Transcend has pledged 10% of its founding shares toward nonprofits focused on scientific research and patient access.