INDIANAPOLIS--(BUSINESS WIRE)--Gate Neurosciences, a synaptic health biotechnology company focused on advancing next-generation precision central nervous system (CNS) treatments, today announced the initiation of a Phase 2 clinical study with the University of Pittsburgh (Pitt) to assess the potential for extending the efficacy of apimostinel – a rapid-acting antidepressant drug candidate that enhances synaptic plasticity – in combination with Pitt’s digital therapeutic.
The Phase 2 study (Clinicaltrials.gov ID: NCT06400121) led by Dr. Rebecca Price Ph.D., the university’s associate professor of psychiatry, psychology and clinical and translational science, will assess the utility of combining Pitt’s Automated Self-Association Training (ASAT) tool in extending the duration of apimostinel’s single-dose antidepressant effects. ASAT is a digital neurocognitive training program that uses cognitive tasks to condition patients to associate thoughts about themselves with positive attributes. The combination of neurocognitive training in the presence of apimostinel is hypothesized to leverage a “primed window of brain plasticity” as a more targeted and efficient method to extend relief in depressed patients.
“Our precision drug candidates work by rapidly enhancing synaptic function and neuroplasticity, which has broad potential across mental health and cognitive disorders,” said Mike McCully, president and CEO of Gate Neurosciences. “This Phase 2 study partnership with Pitt gives us an exciting opportunity to potentially extend apimostinel’s treatment benefit in depressed patients with the ASAT platform, a synergistic and innovative digital tool.”
Dr. Price has previously conducted a similar randomized clinical trial (1,2,3) with the rapid antidepressant drug ketamine, plus ASAT training, in patients with treatment-resistant depression. Dr. Price found that one 40-minute ketamine infusion combined with four days of ASAT exercises had statistically significant extended effects on depression that endured for three months, whereas a typical efficacy response from a single ketamine infusion lasts for up to seven days. Gate’s drug candidates apimostinel and zelquistinel share ketamine’s convergent downstream mechanism of enhancing neuroplasticity via the NMDA receptor; however, both of Gate’s molecules have exhibited a superior safety profile versus ketamine with evidence of reduced dissociative or psychotomimetic side effects.
“We are thrilled to partner with Gate to further explore ASAT’s efficacy with apimostinel and build on our previous success with extending ketamine’s benefit for depressed patients,” said Dr. Price. “ASAT was crafted to complement rapid-acting treatments for psychiatric disorders. It is designed to be as efficient as possible with short digital administrations and shows promise for extending single-dose outcomes by months.”
Apimostinel is a second-generation, intravenous NMDA receptor PAM (positive allosteric modulator) being developed by Gate Neurosciences for acute psychiatric disorders. In a prior single-dose Phase 2 study, apimostinel demonstrated rapid and statistically significant 24-hour antidepressant effects that lasted up to seven days and was well-tolerated. Most recently, Gate’s Phase 1 biomarker study of apimostinel showed positive dose-dependent qEEG biomarkers of NMDAR target activation.
About Gate Neurosciences
Gate Neurosciences is a synaptic health biotechnology company focused on advancing next-generation precision CNS treatments that address growing needs in mental health. The company is developing a portfolio of novel mechanisms of action that enhance synaptic function to address neuropsychiatric and neurocognitive diseases, including major depressive disorder (MDD). Using learnings from extensive clinical, preclinical, and translational data and a better understanding of CNS development challenges, the company is advancing its clinical pipeline using evidence-driven, precision psychiatry approaches.
