Aptinyx completes enrollment of phase 2 trial for oral cognitive impairment treatment

Aptinyx Inc. announced it has completed enrollment in the company’s ongoing phase 2 study of NYX-458, an oral treatment for cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies.

According to a company press release, 99 patients have been enrolled in the phase 2, placebo-controlled study of NYX-458, an N-methyl-D-aspartate (NMDA) receptor positive allosteric modulator. Participants will receive either a daily 30 mg dose of NYX-458 or placebo for 12 weeks and will then be monitored during a 30-day safety follow-up. The company plans to report trial results in the first quarter of 2023.

“The completion of enrollment in our phase 2 study of NYX-458 is a significant milestone for Aptinyx,” Andy Kidd, MD, Aptinyx president and CEO, said in the release. “The study is well-designed to characterize the effects of NYX-458 on established measures of attention, memory and executive function — areas in which many patients with Parkinson’s disease and dementia with Lewy bodies experience challenging deficits.

“As a positive allosteric modulator of NMDA receptors, NYX-458 has the potential to directly address the NMDA receptor hypofunction that underpins cognitive impairment in these patients.”

According to the release, NYX-458 exhibited a favorable safety and tolerability profile in a phase 1 trial across a wide dose range and achieved CNS exposures consistent with exposures observed at efficacious preclinical dose levels.

“We look forward to completing the study and announcing results in the first quarter of next year,” Kidd said.