Synapse, illustration

Gate Neurosciences, founded in 2019, announced today its official launch as a developer of central nervous system (CNS) therapeutics that target synaptic dysfunction in patients. Over the past three years, Gate has acquired the rights to a number of next-generation compounds targeting CNS disorders and has also collected data from thousands of patients dosed across numerous clinical trials that will  aid the company it is future drug development efforts.

The company’s initial focus is to develop novel methods to address synaptic dysfunction that underlie neuropsychiatric and cognitive disorders, including major depressive disorder (MDD).

“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 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.”

Gate’s lead programs are being developed via a platform of novel N-methyl-D-aspartate receptor (NMDAR) modulators that have demonstrated rapid, durable, and safe outcomes across multiple clinical studies. The company says its unique mechanism provides a more direct and well-tolerated approach to enhancing synaptic function and neuroplasticity, compared to other antidepressants.

Its lead program is Zelquistinel, which has completed Phase I EEG biomarker studies and an initial Phase IIa dose exploration study in MDD. The candidate is an oral third-generation NMDAR modulator that was advanced into the clinic by Allergan and later acquired by AbbVie. Gate also acquired global rights to a second-generation NMDAR modulator called Apimostinel, which it is developing for acute psychiatric indications based on a large 24-hour effect size observed in a Phase IIa proof-of-concept study.

“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” said Mike McCully, Gate CEO in a press release. “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.”

According to the company, its development efforts for both Zelquistinel and Apimostinel have been guided, in part, by information it has developed from its first-generation NMDAR molecule called Rapastinel (Glyx-13). Rapastinel has demonstrated its proof-of-concept as a potential treatment for MDD in more than 2,000 patients across multiple clinical studies. The company continues to test the drug in ongoing investigator-led studies to develop a better understanding of appropriate dosing levels of the drug.

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