Phase 2 study follows NYX-458 preclinical data demonstrating reversal of cognitive deficits in non-human primate model of Parkinson’s disease
Fourth Phase 2 study initiated by
“The initiation of this study marks an important milestone as we seek to bring a better therapeutic option to patients suffering from cognitive impairment,” said
“While motor symptoms represent the classical features of Parkinson’s patients, more than half of all people suffering from the disease are also afflicted by cognitive symptoms,” said
About the Phase 2 Cognitive Impairment in Parkinson’s Disease Study
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 135 patients with mild cognitive impairment associated with Parkinson’s disease. The study will evaluate daily oral dosing of NYX-458—10 mg, 30 mg, or 100 mg—compared to placebo over a 12-week period. The effects of NYX-458 on cognitive performance will be evaluated across multiple endpoints related to attention, memory, executive function, visuospatial deficits, and patient quality of life.
About Cognitive Impairment Associated with Parkinson’s Disease
Cognitive impairment affects approximately half of patients with Parkinson’s disease. It is believed that the loss of dopamine, which is known to be associated with the motor symptoms of the disease, leads to dysregulation in processes that are important for cognitive function. Cognitive impairment associated with Parkinson’s disease is distinct from other forms of dementia in that it often presents as deficits in one or two cognitive domains. Attention, memory, executive functioning, and visuospatial function are the most disrupted domains in people with Parkinson’s disease.
NYX-458 is a novel oral NMDA receptor modulator currently in clinical development for the treatment of cognitive impairment associated with Parkinson’s disease. 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.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s business plans and objectives, including future plans or expectations for NYX-458, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical trials, expectations regarding its preclinical development activities, and expectations regarding its uses and sufficiency of capital. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the company’s product candidate development activities and planned clinical studies; the company’s ability to execute on its strategy; regulatory developments in
Source: Aptinyx Inc.