EuMentis Therapeutics Inc., a privately-held biopharmaceutical company developing novel therapeutics for the treatment of neuropsychiatric diseases, today announced it has received an award from the United States Department of Defense (DoD) to develop a novel small molecule therapeutic targeting the extrasynaptic N-methyl-D-aspartate receptor (NMDAR) for the treatment of traumatic brain injury or “TBI.”
The NMDAR is an ion channel which binds glutamate, a neurotransmitter that accounts for approximately 80% of the brain’s excitatory activity. Excess glutamate is linked to multiple neuropsychiatric conditions, including autism spectrum disorder (ASD) and Alzheimer’s disease, as well as further neuronal damage after TBI. A key scientific focus of EuMentis is to advance novel fast-off NMDAR antagonists to block signaling of over-active glutamate receptors in order to restore glutamate balance across diseases and indications, including TBI. The company’s lead NMDAR antagonist, EM-113, is currently entering a Phase 2 study for ASD.
EuMentis will utilize the $3 million DoD award to study three novel fast-off NMDAR antagonists to evaluate TBI in a validated large animal model in 2023 in collaboration with Todd Killbaugh, M.D., Professor of Anesthesiology and Critical Care at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia (CHOP). Once the preclinical study is completed, EuMentis plans to advance the selected lead candidate into a Phase I clinical trial in 2024. To date, EuMentis has received over $11 million in funding from private and government sources to support research and development of its broad pipeline of novel CNS-based therapeutics.
“Currently there are no approved therapeutics for traumatic brain injury, which impact hundreds of thousands of Americans annually and leads to significant disability and death. The Department of Defense recognizes the need for new therapeutic approaches for this urgent public health concern, and we are thrilled to receive their support in this competitive area,” said Mark Tepper, Ph.D., President and Chief Executive Officer of EuMentis. “We believe that our targeting of the extrasynaptic NMDAR with novel small molecules has significant potential to improve the quality of life of patients suffering from TBI, as well as other serious neuropsychiatric conditions. With this non-dilutive funding, along with our network of distinguished advisors and highly experienced team, we are well positioned to rapidly advance a clinical candidate to address this significant unmet need, while continuing to advance our other clinical-stage and preclinical programs.”
Randall Marshall, M.D., EuMentis’ Chief Medical Officer, added, “Years of research point to glutamatergic toxicity as a major cause of long-term impairment after a significant head injury. Astonishingly, more than 5 million Americans are currently living with a TBI-related injury. We look forward to collaborating with Dr. Killbaugh to accelerate our glutamate antagonist approach for TBI toward the clinic under this grant award, as we pursue our goal of improving short- and long-term outcomes for patients by minimizing the damage after brain injury that often leads to permanent disability.”
Dr. Killbaugh commented, “Traumatic brain injury is a complex neurological condition that, despite years of research, still has no approved treatments to date. I am enthusiastic about collaborating with EuMentis and the DoD using this well-validated nonclinical model to identify a potential treatment that can be brought forward into clinical studies.”
Traumatic brain injury is one of the leading causes of death and disability in the United States. Each year, an estimated 1.5 million Americans sustain a traumatic brain injury (Centers for Disease Control and Prevention). Over 223,000 people were hospitalized with TBI in 2019 and there were over 64,000 TBI related deaths in 2020. Today, there are 5.3 million Americans who live with a TBI-related disability representing a market of over $2.4 billion with limited therapeutic options.