Jazz’s Future in PTSD Left Uncertain Following Mid-Stage Trial Failure
22 Dec 2023
Phase 2Clinical Result
Pictured: Man crouched on a bed with his head on his knees/iStock, pcess609
Jazz Pharmaceuticals on Thursday announced top-line Phase II results for JZP150, showing that the investigational fatty acid amide hydrolase inhibitorfatty acid amide hydrolase inhibitor fell short of its primary efficacy endpoint in a mid-stage study of post-traumatic stress disorder.
The Irish biopharma company did not provide specific data in Thursday’s announcement but said that compared with placebo “there was not a statistically significant decrease” in post-traumatic stress disorder (PTSD) symptoms in patients treated with JZP150. The investigational drug also failed key secondary endpoints, including clinician- and patient-assessed disease severity.
Jazz’s stock price dropped 2.6% in response to the readout, according to Seeking Alpha.
Rob Iannone, executive vice president and global head of research and development at Jazz, said in a statement that the company is still conducting a full evaluation of the study’s findings and will share their analyses in the future. However, Iannone added that “based on top-line results, we do not anticipate moving forward with additional JZP150 development in PTSD.”
Designed to be orally available, JZP150 is a selective small molecule inhibitor of the fatty acid amide hydrolase enzyme, the activity of which has previously been associated with arousability and the extinction of negative memories—both key markers of PTSD. This mechanism of action allows JZP150 to potentially target the underlying causes of PTSD.
In assessing JZP150 for PTSD, Jazz ran the Phase II randomized, double-blinded and placebo-controlled trial with 282 adult patients enrolled. JZP150 was given at either 4-mg or 0.3-mg doses and its primary endpoint was the 12-week change in symptom severity, as quantified using the Clinician Administered PTSD Scale.
Key secondary endpoints were also measured using the Clinical Global Impression of Severity and the Patient Global Impression of Severity scales.
Beyond efficacy, the mid-stage study looked at JZP150’s safety and found no new safety signals of concern. The most common treatment-emergent side effects were nausea, urinary tract infection and headache, most of which were mild or moderate in severity.
Thursday’s Phase II failure for Jazz breaks the industry’s winning streak in PTSD in recent months. On Wednesday, Compass Pathways released Phase II data showing that its investigational psilocybin therapy COMP360 was well-tolerated for the treatment of PTSD.
In September 2023, Bionomics announced that its ion channel modulator BNC210 aced the Phase IIb ATTUNE trial, eliciting significant symptom reduction in PTSD patients. A few days earlier, Alto Neuroscience likewise reported a Phase IIb victory for its BDNF-targeted ALTO-100 and its AI-enabled precision psychiatry platform.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
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