Therapy Areas: Central Nervous System
Aptinyx Completes Enrollment in Phase 2b Study of NYX-2925 in Painful Diabetic Peripheral Neuropathy
27 October 2021 - - US-based biopharmaceutical company Aptinyx Inc. (NASDAQ: APTX) has completed enrollment in the company's ongoing Phase 2b study of NYX-2925 for the treatment of painful diabetic peripheral neuropathy, the company said.

Patients recently enrolled in the study are completing the 12-week treatment period and 30-day safety follow-up period. The company expects to report results from the study in early to mid 2Q 2022.

The Phase 2b study is evaluating the efficacy and safety of NYX-2925 in patients with advanced painful DPN. The primary endpoint in the study is the change from baseline in weekly average daily pain score over a 12-week period as reported on the 10-point numeric rating scale.

The Phase 2 study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of NYX-2925 in patients with advanced painful DPN.

Following a screening period, eligible patients are randomized to receive oral doses of NYX-2925 50 mg or placebo once daily over the treatment period.

The primary endpoint in the study is the change from baseline in weekly average daily pain score over a 12-week period as reported on the 10-point numeric rating scale.

Multiple secondary and exploratory endpoints related to pain and patient quality of life are also evaluated.

NYX-2925 is a novel oral NMDA receptor positive allosteric modulator currently in Phase 2 clinical development for the treatment of chronic pain.

In clinical studies, NYX-2925 has demonstrated activity that affects central pain processing, resulting in alleviation of pain and other symptoms associated with chronic pain conditions.

In Phase 1 and Phase 2 clinical studies, NYX-2925 has exhibited a favorable safety and tolerability profile across a wide dose range.

The US Food and Drug Administration has granted Fast Track designation to Aptinyx's development of NYX-2925 for the treatment of neuropathic pain associated with DPN.

Neuropathic pain, associated with various conditions, affects an estimated 7% to 9% of the US population.

Individuals suffering from this condition, regardless of the underlying disorder, are currently treated with a variety of therapies including antidepressants, anticonvulsants, and opioids.

These medications offer inadequate efficacy for a large proportion of patients, are often poorly tolerated due to side effects, and in some cases are associated with abuse.

Painful DPN is one of the largest neuropathic pain conditions. An estimated 7.5 m people in the United States suffer from this condition, which develops in 60% to 70% of people with diabetes when chronically high glucose levels damage nerves and impair transmission of information between the central nervous system and other parts of the body.

Patients suffering from DPN may also experience sensory loss, leading to difficulties with balance, coordination, and walking.

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.
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