A new start-up has launched with an aim of developing therapeutics that address synaptic dysfunction in patients suffering from central nervous system (CNS) disorders.
Gate Neurosciences was founded in 2019 by a team of neuroscientists with the goal of addressing the urgent need for more effective treatments for CNS disorders, and to overcome long-standing challenges in CNS drug development.
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 programmes stem from a platform of novel NMDA receptor modulators, which it believes represents a more direct and well-tolerated approach to enhancing synaptic function and neuroplasticity, compared to ketamine and other next-generation rapid antidepressants.
The company’s lead programme Zelquistinel is an oral NMDAR modulator that has completed multiple Phase 1 EEG biomarker studies and an initial Phase 2a dose exploration study in MDD. Gate has also acquired the rights to the 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.
“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” said 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.”
“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.”