Where Does Aptinyx Go Next After Disappointing Midstage Results for Pain Treatment?

Health and Healthcare

Published: January 16, 2019 11:50 am

Last Updated: January 11, 2020 12:30 pm

Aptinyx Inc. (NASDAQ: APTX) shares were absolutely crushed on Wednesday after the firm reported midstage results from its clinical study in patients with painful diabetic peripheral neuropathy (DPN).

Specifically, Aptinyx announced top-line results from its Phase 2 clinical study of NYX-2925 in subjects with DPN.

Unfortunately, the study did not demonstrate statistically significant separation from placebo on the primary endpoint, change in subjects’ average daily pain scores on the Numerical Rating Scale (NRS) during the final treatment week compared to baseline.

The primary endpoint of the study was the mean change in average daily pain, as measured using the NRS (on which 0 represents no pain and 10 represents worst pain imaginable), at week four of treatment compared to baseline. Key secondary endpoints in the study included worst daily pain, pain on walking and sleep interference.

Of the three dose levels evaluated, 50 mg showed the most meaningful improvements across multiple measures. NYX-2925 was well tolerated in the study with no serious adverse events.

Norbert Riedel, Ph.D., President and CEO of Aptinyx, commented:

While the study did not meet its primary endpoint, we observed improvements on multiple measures, differential activity across dose levels, and a very favorable safety profile. Coupled with the positive evidence of biological activity relevant to central pain processing from our recently announced interim analysis of a fibromyalgia study, we believe the total body of clinical data indicates the potential of NYX-2925 to treat chronic pain. We will continue to interrogate the full dataset to determine the most appropriate path forward for NYX-2925 in development for chronic pain. Our talented team also remains steadfastly focused on continued execution across our other pipeline programs, including NYX-783 for the treatment of post-traumatic stress disorder and NYX-458 for the treatment of Parkinson’s disease cognitive impairment. Our strong balance sheet will fund our execution and achievements on these programs in 2019 and 2020.

Shares of Aptinyx were last seen down about 70% at $5.32, with a 52-week range of $5.02 to $32.25. The stock has a consensus analyst price target of $35.67.