Clinical-stage biopharma firm Aptinyx has restarted recruiting and screening participants in a Phase II study of NYX-2925 for treating patients with painful diabetic peripheral neuropathy (DPN).
With the increase in Covid-19 cases in the US, the company has suspended enrolment of participants in the trial.
A novel oral NMDA receptor modulator, NYX-2925 is currently in Phase II clinical development for treating chronic pain.
In clinical studies, NYX-2925 showed activity that affects central pain processing, resulting in mitigation of pain and other symptoms linked to chronic pain conditions.
Aptinyx CEO Norbert Riedel said: “We are pleased to have recommenced our Phase II study in painful DPN and remain committed to responsible clinical investigation while prioritising the safety of patients and study personnel during the ongoing Covid-19 pandemic.
“This study in painful DPN represents the second ongoing Phase II study of NYX-2925 in chronic pain, alongside our concurrent study in fibromyalgia, and we expect to read out data from each of these studies in the first half of 2022.”
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The randomised, double-blind, placebo-controlled study will analyse the efficacy and safety of NYX-2925 in patients with advanced painful DPN.
It will enrol approximately 200 participants. After the screening period, those eligible will randomly receive oral doses of NYX-2925 50mg or placebo once daily during the treatment duration.
Change from baseline in average daily pain score over 12 weeks as reported on the 10-point numeric rating scale (NRS) will be the trial’s primary endpoint.
In addition, various secondary endpoints related to pain and patient quality of life will also be assessed.
Aptinyx expects to announce top-line data from the study in the first half of next year.
Earlier, the company received ‘Fast Track’ designation from the US Food and Drug Administration (FDA) to develop NYX-2925 for treating neuropathic pain associated with DPN.
In October last year, Aptinyx reported positive results from the first Phase II study of its new NMDA receptor modulator, NYX-783, in patients with post-traumatic stress disorder (PTSD).