CARMEL, Ind.– Gate Neurosciences today announced it has officially launched to develop its next-generation therapeutics addressing synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.
Gate was founded in 2019 by a team of neuroscience industry veterans to address the increasingly urgent need for more effective treatments for CNS disorders, and to overcome long-standing challenges in CNS drug development. Since its founding, the company has acquired a robust portfolio of next-generation compounds from large pharma, along with corresponding data from thousands of patients dosed across numerous clinical trials that will inform and de-risk future development.
“We formed Gate to bring forward precision medicine approaches to CNS disorders, such as biomarkers and enrichment for responders, similar to the early days of targeted oncology drug development” remarked Anantha Shekhar, co-founder of Gate Neurosciences and Senior Vice Chancellor for Health Sciences and Dean of the University of Pittsburgh School of Medicine. “Gate’s lead programs are supported by a uniquely robust package of clinical and translational data across thousands of patients, and we’re excited to continue advancing the molecules using deep precision insights.”
The company is focused on developing novel mechanisms that address synaptic dysfunction underlying neuropsychiatric and cognitive disorders, including major depressive disorder (MDD). Gate’s lead programs stem from a platform of novel NMDA receptor modulators that have demonstrated rapid, durable, and safe outcomes across multiple published and unpublished clinical studies. The company’s unique mechanism represents a more direct and well-tolerated approach to enhancing synaptic function and neuroplasticity, compared to ketamine and other next-generation rapid antidepressants.
“Current therapies for mental health disorders are extremely inadequate and patients need better options. There has never been more evidence that enhancing underlying synaptic function is the ideal therapeutic approach” commented Mike McCully, Chief Executive Officer at Gate. “We believe our novel synaptic modulators are the most potent and proven compounds that enhance synaptic function to achieve rapid, durable, and safe outcomes with potential across a wide range of neuropsychiatric disorders.”
Gate’s lead program, Zelquistinel, is an oral 3rd generation NMDAR modulator that was discovered by Naurex and advanced into the clinic by Allergan before its acquisition by AbbVie. To date, Zelquistinel has completed multiple Phase 1 EEG biomarker studies and an initial Phase 2a dose exploration study in MDD. Gate also acquired global rights to the 2nd generation NMDAR modulator Apimostinel, which the company is developing for acute psychiatric indications based on a large 24-hour effect size observed in a Phase 2a proof-of-concept study. These programs are supported by a deep de-risking translational data package, including over 500 patients dosed with Apimostinel and Zelquistinel across multiple clinical studies, to inform future development of the molecules.
The company’s development plans for Zelquistinel and Apimostinel also leverage key learnings from the first-generation NMDAR molecule, Rapastinel (Glyx-13), which demonstrated proof-of-concept across multiple clinical MDD studies in over 2,000 patients combined. Gate is collaborating with psychiatry leaders to continue exploring Rapastinel in investigator-led clinical studies, given its established safety profile and the company’s more advanced understanding of Rapastinel’s dose dynamics.
