Aptinyx has concluded subject enrolment in its Phase II clinical trial of NYX-458 in cognitive impairment linked to Parkinson’s disease and dementia with Lewy bodies. 

The ongoing, double-blind, randomised, parallel-design, placebo-controlled trial enrolled a total of 99 subjects.  

It will analyse NYX-458’s safety, tolerability, and possible cognitive benefits in study subjects.

These subjects have mild cognitive impairment, mild dementia linked to Parkinson’s disease, or dementia with Lewy bodies. 

In the trial, daily oral 30mg doses of NYX-458 will be assessed against a placebo for 12 weeks. 

The impact of the therapy across several neurocognitive endpoints focusing on memory, attention, and executive function will also be evaluated. 

Subjects who have been enrolled into the trial lately are concluding the 12-week treatment period and a safety follow-up period of 30 days. 

The company anticipates reporting trial data in the first quarter of next year.

A new oral NMDA receptor, positive allosteric modulator, NYX-458 is in the clinical development stage.

In the non-human primate model that is well-translatable to Parkinson’s disease in humans, it demonstrated capabilities to reverse cognitive deficits. 

NYX-458 also showed to enhance cognitive performance across several other neurodegeneration preclinical models. 

In a Phase I trial, the therapy showed a favourable safety and tolerability profile across various dose ranges and attained CNS exposures in line with those seen at efficacious dose levels in preclinical research.

Aptinyx president and CEO Andy Kidd said: “The study is well-designed to characterise 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.”

In April this year, the company reported that NYX-2925 failed to meet the primary endpoint of the Phase IIb trial in painful diabetic peripheral neuropathy patients.