#USA #New York #PTSD #Transcend Therapeutics #TSND-201

Transcend Therapeutics' Promising Breakthrough in PTSD Treatment

Transcend Therapeutics is making waves in the realm of mental health treatment with its recent announcement that the neuropsychotropic medication, TSND-201, has met its primary endpoint during the Phase 2 clinical trial known as IMPACT-1. This landmark study is pivotal, as it represents the first significant advancement in the pharmacological treatment of Post-Traumatic Stress Disorder (PTSD) in more than two decades.

The clinical trial enrolled 65 patients suffering from severe PTSD, as classified by a Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) score of 35 or above. Participants had exhausted previous treatment options, making them a particularly challenging group for potential interventions. TSND-201, derived from methylone, a rapid-acting neuroplastogen, was administered in four doses, each spaced one week apart. The results seen by the end of Day 64 of the trial were encouraging, with a statistically significant placebo-adjusted CAPS-5 score improvement of -9.64 points (p = 0.011).

In addition to showing efficacy in alleviating PTSD symptoms, TSND-201 exhibited rapid action, with meaningful reductions in CAPS-5 scores starting as early as Day 10 of the treatment (placebo-adjusted improvement of -8.00 points; p = 0.012). This kind of speed in therapeutic response is critical in the treatment of PTSD, where timely intervention can drastically improve a patient’s quality of life and functionality. Throughout the trial period, participants receiving TSND-201 showed consistent improvement without a decline in efficacy.

Blake Mandell, Co-Founder and CEO of Transcend Therapeutics, expressed optimism regarding the results, stating, "We are encouraged by the positive Phase 2 results demonstrating TSND-201's potential as a rapid-acting and durable treatment for patients with PTSD." With plans to engage with the FDA regarding the development of a Phase 3 program, Transcend is poised to make significant strides in addressing this critical mental health issue.

The study also measured various secondary endpoints, revealing robust improvements: 57.1% of patients achieved a 50% improvement from baseline on the CAPS-5, and 32.1% reached remission, defined by scores of 11 points or less. Additionally, a remarkable 60.7% of participants no longer met the diagnostic criteria for PTSD after treatment, in stark contrast to the 30.8% in the placebo group.

Regarding safety, TSND-201 was deemed generally safe and well-tolerated. The majority of adverse effects reported were transient, resolving within the same day as dosing. Commonly reported issues included headache, decreased appetite, dizziness, and insomnia. However, one serious event involving a seizure occurred in a patient with a previous history of seizures, classified as unrelated to the treatment. This highlights the need for careful monitoring in participants with a complex medical history.

Experts like Dr. Murray B. Stein, Distinguished Professor of Psychiatry and Public Health at UC San Diego, have affirmed the significance of these findings, stating, "The results of this study suggest that TSND-201 may represent a significant clinical breakthrough — demonstrating clinically meaningful efficacy with a rapid onset." Dr. Stein emphasizes that such rapid-acting therapies could redefine treatment approaches for PTSD patients, offering hope to many individuals who have struggled for years to find effective relief.

Founded in 2021, Transcend Therapeutics is dedicated to developing rapid-acting treatments for neuropsychiatric diseases. With an impressive track record that includes pivotal contributions to numerous FDA approvals, the company's leadership team is well-equipped to drive TSND-201 through subsequent phases of clinical research.

TSND-201’s proprietary formulation shows promise in its ability to work without hallucinogenic effects, acting on the monoamine transporters. This characteristic is particularly vital; it opens avenues for more patients to access treatment without the risks associated with psychedelic substances, thus removing a barrier for those fearful of traditional psychiatric medications.

Given that PTSD affects around 13 million Americans annually, and only two medications are currently FDA-approved to treat the condition, the need for new, effective treatments has never been more pressing. As Transcend Therapeutics gears up for its next step toward regulatory approval, the hope is that TSND-201 could soon offer a new alternative to those suffering the debilitating effects of PTSD, fundamentally altering the landscape of treatment options for this challenging and often overlooked mental health condition.