Aptinyx sees initiating Phase 2 NYX-2925 study in 2H19
Aptinyx highlighted detailed analysis of the recently completed Phase 2 study of its novel NMDA receptor modulator, NYX-2925, in patients with painful diabetic peripheral neuropathy. These results were recently presented at the American Pain Society Scientific Meeting held April 4-6 in Milwaukee, Wisconsin. As Aptinyx reported in January of 2019, NYX-2925 was safe and well-tolerated with no serious adverse events reported and NYX-2925 did not demonstrate statistically significant separation from placebo on the primary endpoint, change in patients' average daily pain scores on the Numeric Rating Scale, in the total study population. At the APS Scientific Meeting, Aptinyx presented post hoc analyses of the data from the study demonstrating that, as the duration of patients' DPN diagnosis increased, the effect size of NYX-2925 also increased. The presentation highlighted data from a sub-group of 127 patients with advanced DPN-a DPN diagnosis for four years or longer-representing over 42% of the patients in the study. These patients are particularly relevant to the mechanism of NYX-2925, which addresses the increasingly centralized pain perceived when they experience chronic pain over a prolonged period of time. Consistent with the dose response observed in the total study population, the 50 mg dose group showed the greatest treatment benefits in this advanced DPN patient population. In these patients, the 50 mg dose group showed a reduction from baseline to week four on the primary efficacy endpoint, average daily pain, of 1.93 points, representing a 30% improvement from baseline. Clinically meaningful improvements were also observed in the 50 mg dose group from baseline to week four on all key secondary endpoints: reduction in average worst daily pain of 1.79 points; reduction in average pain on walking of 1.85 points: and reduction in daily sleep interference, a measure of the extent to which a patient's pain interfered with their sleep, of 2.14 points. On some of these endpoints, significant separation was observed by week two of treatment. Across all endpoints, the effects of the 50 mg dose continued to improve from week to week and no plateau was observed by week four. "The findings from the detailed analysis of the study provide a strong scientific foundation and direction for advancing the development of NYX-2925 for the treatment of chronic pain," said Norbert Riedel, Ph.D., president and CEO of Aptinyx. "Based on the clear signals of analgesic activity that were observed in advanced DPN patients, we look forward to initiating our next study in painful DPN later this year." The company plans to initiate an additional clinical study of NYX-2925 for the treatment of painful DPN in the second half of 2019.