EuMentis Therapeutics Inc. Receives $3-Million Award from US DoD to Advance its Novel NMDA Receptor Antagonist for Traumatic Brain Injury

EuMentis Therapeutics Inc. recently 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 that 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, MD, 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 TBI, 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, PhD, 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, MD, 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 US. 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.

EuMentis Therapeutics Inc. is a privately held clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat neuropsychiatric conditions with high unmet need. The Company’s most advanced product candidate, EM-221, is a best-in-class oral PDE10A inhibitor designed to modulate the dopamine D2 pathway specifically in the striatum. EuMentis plans to initiate a phase 2 study of EM-221 for the treatment of Tourette Syndrome in H2 2023. EuMentis is also developing EM-113, an uncompetitive fast-off NMDA receptor antagonist for the treatment of Autism Spectrum Disorder patients with elevated brain glutamate levels as determined by MR spectroscopy. EuMentis is also expanding its pipeline through the development of extrasynaptic NMDAR antagonists for treatment of multiple conditions in which elevated glutamate levels contribute to the pathophysiology including Traumatic Brain Injury (TBI), at present funded by an award from the United States Department of Defense. EuMentis was founded in 2019 with the mission to develop novel therapies to improve the quality of life of patients suffering from central nervous system (CNS) disorders. For more information, visit www.EuMentisTx.com.