200-patient painful diabetic peripheral neuropathy study and 300-patient fibromyalgia study build on previous compelling data obtained in these indications
Top-line efficacy and safety data anticipated in late 2020 or early 2021 for painful DPN and 1H 2021 for fibromyalgia
Studies to be discussed on today’s financial results conference call at
“Patients suffering from painful DPN and fibromyalgia have limited therapeutic options, which have inconsistent safety and efficacy,” said
“These study initiations represent an important milestone in the development of NYX-2925 for chronic centralized pain conditions,” said
The company will discuss these studies during its planned live conference call today at
About the Phase 2 Painful DPN Study
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 DPN. Approximately 200 patients will be enrolled in the study. Following a screening period, eligible patients will be 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 average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). Multiple secondary endpoints related to pain and patient quality of life will also be evaluated.
About the Phase 2 Fibromyalgia Study
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 fibromyalgia. Approximately 300 patients will be enrolled in the study. Following a screening period, eligible patients will be randomized to receive oral doses of NYX-2925 50 mg, NYX-2925 100 mg, or placebo once daily over the treatment period. The primary endpoint in the study is the change from baseline in average daily pain score over a 12-week period as reported on the 10-point numeric rating scale (NRS). Multiple secondary endpoints related to pain, fatigue, cognitive performance, and patient quality of life will also be evaluated.
About Neuropathic Pain and Painful Diabetic Peripheral Neuropathy
Neuropathic pain, associated with various conditions, affects an estimated 7% to 9% of the U.S. 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 5 million people in
Fibromyalgia is a chronic condition associated with widespread pain and tenderness, as well as general fatigue. Fibromyalgia is considered by many to be a condition that is largely mediated in the central nervous system, given that fibromyalgia sufferers often present without a direct peripheral insult or injury. People suffering from fibromyalgia also often experience sleep disruption, depressed mood, and cognitive impairment. It is estimated that, in
NYX-2925 is a novel oral NMDA receptor modulator currently in Phase 2 clinical development for the treatment of chronic pain. In clinical studies, NYX-2925 has been shown to have 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.
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 the company’s product candidates, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical studies, the timing for the company’s receipt of data from its clinical studies, 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; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in
Source: Aptinyx Inc.