Benzinga | Jan 4, 2021 07:58AM EST

Aptinyx Announces Recommencement Of Phase 2 Study Of NYX-2925 In Patients With Painful Diabetic Peripheral Neuropathy

Study has resumed following suspension of enrollment due to escalation of COVID-19 pandemic

Aptinyx now has two parallel-design, placebo-controlled Phase 2b studies ongoing with NYX-2925 in highly prevalent chronic pain indications

Data readouts for NYX-2925 studies in both painful DPN and fibromyalgia expected in 1H 2022

Aptinyx Inc. (NASDAQ:APTX), a clinical-stage biopharmaceutical company developing transformative therapies for the treatment of brain and nervous system disorders, today announced that in December it recommenced patient recruitment and screening in a Phase 2 study of NYX-2925 in patients with painful diabetic peripheral neuropathy (DPN). Enrollment in the study had been suspended due to the escalation of the COVID-19 pandemic in the United States.

"We are pleased to have recommenced our Phase 2 study in painful DPN and remain committed to responsible clinical investigation while prioritizing the safety of patients and study personnel during the ongoing COVID-19 pandemic," said Norbert Riedel, Ph.D., chief executive officer of Aptinyx. "This study in painful DPN represents the second ongoing Phase 2 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."

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 painful 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. Aptinyx anticipates reporting top-line data from this study in the first half of 2022. More information about this study can be found on clinicaltrials.gov (NCT04146896).