Tonix plunges 68% after PTSD drug failure
pharmafile | July 30, 2018 | News story | Research and Development, Sales and Marketing | PTSD, Tonmya, pharma, tonix
Tonix Pharmaceuticals has announced that it has terminated its Phase 3 study of Tonmya (cyclobenzaprine HCl sublingual tablets) in military-related posttraumatic stress disorder (PTSD) after the drug failed to prove adequate separation from placebo in its primary endpoint.
The decision to stop the trial came on the back of a recommendation from an Independent Data Monitoring Committee following a review of data for the first 50 participants after 12 weeks of treatment. The primary endpoint of the study was mean change versus baseline in the severity of PTSD symptoms as measured using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); using this metric, Tonmya failed to show any clear benefit versus placebo.
The news of the failure cut deeply into Tonix’s share price, sending it plunging 68%. However, an announcement from the firm did recognise some positives in the data.
“We are encouraged by the meaningful clinical improvement at week four, which replicates findings in the previously-reported Phase 2 AtEase Study. We believe the results from the HONOR study will help to design the next pivotal study,” commented Dr Seth Lederman, President and Chief Executive Officer. “We plan to meet with the FDA as soon as possible to discuss the HONOR results and our proposal to conduct the primary analysis at the week-four time point in the next pivotal study.”
“These results underscore the challenges in designing and conducting well-controlled clinical studies in PTSD, especially military-related PTSD,” he continued. “We thank the participants, their families and friends, and the investigators who participated in the HONOR study. We are committed to seeking potential treatments for PTSD including advancing TNX-601 (tianeptine oxalate) for daytime treatment of PTSD.”
Matt Fellows
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