Aptinyx Inc. (NASDAQ: APTX) stock declined by 0.29% at last close while the APTX stock price has been observed falling more during the after-hour session, by 9.74%. Aptinyx Inc. is a clinical-stage biopharmaceutical business that develops and commercializes unique synthetic small molecules for the cure of brain and nervous system diseases.
What’s going on?
After receiving the papers from its recent Type C meeting with the US Food and Drug Administration, APTX stated that it has completed the design of its Phase 2b study for NYX-783 in patients with post-traumatic stress disorder. The Phase 2b program is expected to begin in the fourth quarter of 2021, according to APTX. Aptinyx also disclosed that it discovered a statistical mistake committed by the contract research company that did the statistical study of the previously completed exploratory Phase 2 trial in PTSD as part of its preparation for Phase 2b. As a result, APTX has modified the statistical analysis for the exploratory Phase 2 trial, which has no bearing on the research’s findings.
NYX-783 will be evaluated at two dosage levels in the Phase 2b program: 50 mg (Study 1) and 150 mg (Study 2). In a prior Phase 2 exploratory research, the 50 mg dosage worked best, and the 150 mg dosage was chosen to assess the effects of a higher dosage level. Study 1 is scheduled to begin in the fourth quarter of 2021, while Study 2 is scheduled to begin in the first quarter of 2022.
Norbert Riedel, CEO of Aptinyx stated:
APTX is excited to be moving forward with NYX-783’s Phase 2b advancement in PTSD, and they think that its method of improving extinction learning through NMDA receptor regulation has the ability to treat the underlying pathology of PTSD. APTX acted promptly to reanalyze and provide updated statistical analysis after discovering the CRO’s mistake in statistical analysis in their earlier research. It’s essential to highlight that the updated analysis has no bearing on the study’s findings, their confidence in NYX-783’s effectiveness and safety profile, or their plans for the drug’s clinical advancement. Starting in the fourth quarter, APTX plans to advance NYX-783 into Phase 2b.