Aptinyx has started dosing in a Phase 1, first-in-human study for its lead therapeutic candidate, NYX-2925.
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The randomized, double-blind, placebo-controlled study will enroll approximately 70 healthy volunteers to evaluate the safety and tolerability of NYX-2925 at multiple doses.
The study will include both single-dose and multiple-dose ascending cohorts, each with placebo controls. Aptinyx anticipates utilizing the results of the study to guide dose selection for Phase 2 efficacy studies in specific neurologic indications.
"Our team's extraordinary efforts have allowed us to initiate our first clinical study less than a year after spinning out our company and platform from Naurex," said Norbert Riedel, Ph.D., president and chief executive officer of Aptinyx.
"As we conduct this study, we will also finalize the selection of one or more specific indications for Phase 2 studies of NYX-2925. We have seen compelling evidence of efficacy for NYX-2925 in preclinical models of multiple neurologic conditions, and will move forward in the disease areas in which we believe we can have the greatest potential therapeutic impact."
Aptinyx's chemistry and discovery platform is yielding numerous additional small-molecule modulators of the NMDA receptor, which are currently in preclinical development.
The company's compounds are designed to enhance synaptic plasticity — or strengthen the network for neural cell communication — a clinically validated mechanism with therapeutic potential across multiple nervous system conditions.