Aptinyx’s Hopes Dashed as Parkinson’s Treatment Fails in Clinical Trials

Aptinyx’s hopeful drug, NYX-458, has failed to meet its primary endpoint in a Phase II clinical trial involving patients suffering from cognitive impairment associated with Parkinson’s disease and dementia with Lewy bodies, the Illinois biotech company announced on Tuesday. Despite the setback, Aptinyx remains committed to their mission of developing treatments for neurological disorders.

The development of NYX-458 has come to an end, marking a new chapter for the company. This conclusion marks a significant milestone in the company’s journey and will undoubtedly bring about exciting new opportunities.

Aptinyx is taking steps to ensure its financial security while it pursues other strategic business alternatives, the company announced Tuesday. To do this, it has decided to terminate a Phase IIb trial of NYX-783 in post-traumatic stress disorder and implement cost-cutting measures. These measures will help ensure Aptinyx’s success in the future.

NYX-783 is a promising candidate for the company’s NMDA receptor modulation platform, and to ensure its advancement, the company will be conducting early analysis of the data to determine the next steps and explore alternative options. According to Andy Kidd, M.D., president and CEO, this analysis is crucial for furthering the candidate’s potential.

Due to limited financial resources, Aptinyx has regretfully decided to discontinue its program, joining a growing chorus of companies making similar decisions in the industry.

The completion and readout of the full PTSD study has been extended due to the difficulty of raising capital, so much so that our debt and other obligations are projected to outstrip our available cash.

Aptinyx’s groundbreaking platform has revealed a groundbreaking discovery: NYX-458, an oral small-molecule drug that can modulate the N-methyl-D-aspartate receptor without blocking or hyper-activating it. This could potentially be the key to unlocking treatments for a range of central nervous system conditions.

In a clinical trial of 99 patients, NYX-458 failed to demonstrate any clinically significant advances in everyday function and cognitive performance when compared to the placebo. After 12 weeks of treatment with a 30-mg dose of NYX-458, no significant improvements were seen in comparison to the control group.

NYX-783 is an exciting new oral NMDA modulator with the potential to revolutionize the treatment of PTSD and opioid use disorder. Studies are currently underway to explore the efficacy of this promising candidate drug in both conditions. If successful, it could provide a much-needed breakthrough in the treatment of these debilitating illnesses.

Aptinyx’s Losing Streak

Aptinyx has unfortunately experienced failure before in the CNS space, but NYX-458 isn’t the only one.

In April 2022, NYX-2925, an oral modulator of the NMDA receptor, was unable to demonstrate significant benefit in a Phase IIb clinical trial for painful diabetic peripheral neuropathy (DPN). This disappointing outcome is a setback for the company, which had high hopes for the promising drug.

Patients treated with Aptinyx’s candidate, NYX-2925, saw improvements in their average daily pain scores, though not enough to statistically differentiate it from placebo. Fortunately, no safety issues were observed.

Although Aptinyx’s DPN endeavor unfortunately failed to deliver, the company remains optimistic that their drug candidate NYX-2925 could offer encouraging results in an upcoming Phase IIb study of fibromyalgia, a debilitating condition characterized by chronic pain.

In August 2022, the candidate NYX-2925 fell short of its primary endpoint in an indication, despite an early trend of clinically meaningful pain improvement in patients. Unfortunately, this effect was not sustained throughout the study, and the overall benefit of the candidate did not surpass that of a placebo.

Leave a Comment