Moleac’s NeuroAiD™II Improves Post-Concussion Symptoms, Quality of Life, and Mood after a Mild Traumatic Brain Injury

Dec 4, 2023 | News

  • With its targeted multimodal approach, NeuroAiD™II offers a broad range of therapeutic benefits to TBI patients.
  • NeuroAiD™II was well-tolerated by TBI patients with a favourable safety profile.

SINGAPORE, December 4, 2023 – Moleac announced promising results from the SAMURAI double-blind study in patients with mild traumatic brain injury (mTBI) receiving a 6-month course of NeuroAiD™II. In the study, the NeuroAiD™II group showed significant improvement in their post-concussion symptoms, quality of life and mood, compared to those in the placebo group.   

Presented by Professor Valery Feigin at the World Congress of Neurology, last October in Montreal, these results expand the list of therapeutic benefits of NeuroAiD™II observed in previous clinical trials conducted on TBI patients, and confirm its favourable safety profile1, 2, 3. 

In the SAMURAI study, mTBI patients underwent a series of tests assessing various types of impairments and their recovery over time. For cognition, a self-assessment was done by the patient using a computerized scale, the Computerized Neurocognitive Assessment-Vital Signs (CNS-VS). For post-concussion symptoms, quality of life and mood, the tests were conducted by the investigators using 3 different scales: the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), the Quality of Life after Brain Injury (QOLIBRI) scale, and the Hospital Anxiety and Depression Scale (HADS) respectively. 

While the improvement of CNS-VS self-assessment score was not different between groups at the 6-month and 9-month time points with a surprising improvement in the placebo group, the assessments performed by investigators showed highly statistically significant benefits of NeuroAiD™II over placebo at both 6-month and 9-month time point, and on the 3 scales. These positive results reflect the durable benefits provided by NeuroAiD™II, even after treatment discontinuation.

“Persistent symptoms following a TBI can severely affect a patient’s day-to-day life. Following the pilot study BRAINS1, we are further encouraged by SAMURAI, illustrating the wide spectrum of benefits provided by NeuroAiD™II in helping patients to achieve a holistic recovery in the physical, cognitive and emotional aspects,” said David Picard, CEO of Moleac. 

Professor Feigin added, “The trial showed that although NeuroAid did not significantly improved cognitive functioning in post mild traumatic brain injury individuals, it significantly reduced various other complaints associated with the injury (lightheadedness, headaches, dizziness, anxiety, depression etc) and improved overall health-related quality of life after mTBI. I have no doubts that, when indicated, millions of individuals with mTBI could benefit from using NeuroAid to alleviate their post-injury symptoms.”

TBI is an injury caused by a mechanical impact on the brain or skull or by the penetration of objects into the skull. Damage and death of brain cells often lead to neurological and cognitive deficits. The global incidence of TBI is about 50 to 60 million new events each year, with mTBI representing more than 90% of all TBI4. After one year, 20% to over 30% of mTBI patients continue to experience clinically significant sequelae and over 80% remain symptomatic5. Persistent deficits can highly affect one’s ability to live independently5. Moreover, these physical, cognitive, and emotional symptoms may persist for a long time6,7. This represents an urgent need for TBI treatment to not only treat physical symptoms but to positively impact the psychological and emotional well-being of the patients.

Dr. Sylvain Durrleman, Head of Medical Affairs at Moleac, commented, “Recovery from TBI is complex and multidimensional. With its multimodal mechanism of action, NeuroAiD™II is well-suited for TBI recovery, showing positive clinical impacts on physical symptoms and important parameters of the quality of life.” 

On how the results may contribute to clinical practice in the disease area, Dr. Durrleman added, “We hope the results are meaningful to both healthcare practitioners and patients, further demonstrating the benefit of NeuroAiD™II in promoting recovery processes.”

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