Policy & Regulation
Aptinyx Recommences Phase 2 Study of NYX-458 in Patients with Cognitive Impairment Associated with Parkinson's Disease Dementia and Dementia with Lewy Bodies
7 April 2021 - - US-based biopharmaceutical company Aptinyx Inc. (NASDAQ: APTX) has recommenced patient screening in a Phase 2 study of NYX-458 in patients with mild cognitive impairment and mild dementia associated with Parkinson's disease and dementia with Lewy bodies, the company said.

The company anticipates reporting data from this study in the second half of 2022.

The Phase 2 study is a randomized, double-blind, parallel-design, placebo-controlled study to evaluate the safety and potential cognitive benefits of NYX-458 in approximately 100 patients with mild cognitive impairment or mild dementia associated with Parkinson's disease or prodromal or manifest dementia with Lewy bodies.

The study will evaluate daily oral dosing of NYX-458 30 mg compared to placebo over a 12-week period.

The study will evaluate the overall safety and tolerability of NYX-458 in patients and the potential cognitive benefits of NYX-458 will be evaluated across multiple neurocognitive endpoints focused on attention, memory, and executive function.

Aptinyx anticipates reporting data from this study in the second half of 2022.

About Cognitive Impairment Associated with Parkinson's Disease and Dementia with Lewy Bodies
Cognitive impairment associated with Parkinson's disease and dementia with Lewy bodies is characterized by a broad range of deficits related to attention, memory, and executive function.

A common disease pathology, elevated levels of alpha synuclein, is implicated in these conditions.

Alpha synuclein has been shown to contribute to a decrease in NMDA receptor expression and activity, leading to a decline in cognitive and functional abilities.

It is estimated that approximately 1.4m people in the United States suffer from cognitive impairment due to Parkinson's disease or dementia with Lewy Bodies, which together account for 15-25% of newly diagnosed dementia patients.

Current treatment options for cognitive impairment associated with Parkinson's disease and dementia with Lewy bodies are limited, with only one approved treatment for PDD and no treatments approved for DLB.

NYX-458 is a novel oral NMDA receptor modulator currently in clinical development for the treatment of cognitive impairment associated with Parkinson's disease and dementia with Lewy bodies. NYX-458 has been shown to reverse cognitive deficits in non-human primates in a model that is highly translatable to Parkinson's disease in humans.

NYX-458 has also been shown to improve cognitive performance across various other preclinical models of neurodegeneration.

In a Phase 1 clinical study, NYX-458 exhibited a favorable safety and tolerability profile across a wide dose range and achieved CNS exposures consistent with exposures observed at efficacious preclinical dose levels.

Aptinyx is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of proprietary synthetic small molecules for the treatment of brain and nervous system disorders.

Aptinyx has a platform for discovery of novel compounds that work through a unique mechanism to modulate, rather than block or over-activate, NMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication.

The company has three product candidates in clinical development in central nervous system indications, including chronic pain, post-traumatic stress disorder, and cognitive impairment.

Aptinyx is also advancing additional compounds from its proprietary discovery platform, which continues to generate a rich and diverse pipeline of small-molecule NMDA receptor modulators with the potential to treat an array of neurologic disorders.
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