Jazz Pharmaceuticals Faces Setback in JZP150 Phase II Trial for PTSD Treatment

Jazz Pharmaceuticals recently released the top-line findings from Phase II trials for JZP150, an experimental fatty acid amide hydrolase inhibitor targeted at post-traumatic stress disorder (PTSD). Disappointingly, the drug fell short of meeting its primary efficacy endpoint in this mid-stage study.

Despite refraining from disclosing specific data, the Irish biopharma company highlighted that patients treated with JZP150 did not exhibit a statistically significant reduction in PTSD symptoms compared to the placebo group. The investigational drug also struggled to achieve critical secondary endpoints, including assessments of disease severity conducted by both clinicians and patients.

Reacting to the findings, Rob Iannone, Executive Vice President and Global Head of Research and Development at Jazz, expressed in an official statement that the company is presently conducting a comprehensive assessment of the study’s results. While Iannone mentioned that a detailed analysis would be disclosed later, he conveyed that, considering the top-line results, Jazz does not foresee progressing with the further development of JZP150 for PTSD.

The announcement of the Phase II setback led to a 4% decline in Jazz Pharmaceuticals’ shares in after-market trading.

Jazz Pharmaceuticals (JAZZ.O) confirmed on Thursday that its PTSD drug did not achieve the primary objective in the mid-stage study and subsequently declared its decision not to pursue additional development of JZP150.

PTSD, a mental health condition triggered by traumatic events, extends beyond combat and affects civilians as well, with occurrences such as natural disasters, abuse, or other traumas acting as potential triggers.

Crafted for oral delivery, JZP150 acts as a targeted small molecule inhibitor focused on the fatty acid amide hydrolase enzyme. Its mode of action is linked to arousability and the suppression of negative memories, addressing pivotal elements of PTSD with the aim of targeting the root causes of the condition. The Phase II trial, encompassing 282 adult patients in a randomized, double-blinded, and placebo-controlled setup, administered JZP150 at either 4-mg or 0.3-mg doses. 

The primary end-point, measuring the 12-week alteration in symptom severity, was evaluated utilizing the Clinician-Administered PTSD Scale, while secondary endpoints were gauged using the Clinical Global Impression of Severity and the Patient Global Impression of Severity scales.

Beyond assessing efficacy, the mid-stage study closely examined the safety profile of JZP150, uncovering no novel safety signals of apprehension. The prevailing treatment-emergent side effects, including nausea, urinary tract infection, and headache, predominantly manifested in mild to moderate severity.

Jazz’s Phase II setback with JZP150 stands in contrast to recent successes in the industry for PTSD treatments. Compass Pathways reported positive Phase II data for its investigational psilocybin therapy COMP360, while Bionomics showcased success in the Phase IIb ATTUNE trial for its ion channel modulator BNC210 in September 2023. Likewise, Alto Neuroscience marked a triumph in Phase IIb for its BDNF-targeted ALTO-100 and its AI-driven precision psychiatry platform a few days prior.

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