Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) announced this morning that it would be halting its Phase 3 study of its Tonmya drug, which caused its stock price to drop in dramatic fashion.
After its twelve-week trial, Tonmya, a drug that treats military-related post-traumatic stress disorder (PTSD), showed “inadequate separation from placebo.”
12-Week Study
550 participants were involved in the study that stretched across 30 different US clinics sited. The Independent Data Monitoring Committee (IDMC) reviewed the results of the first 50% of the participants and recommended that the trial be stopped, based on the results that were found at 12 weeks.
Tonix Pharmaceuticals is based in New York and specializes in producing drugs that treat specific central nervous system conditions.
“These results underscore the challenges in designing and conducting well-controlled clinical studies in PTSD, especially military-related PTSD. 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,” said CEO and President of Tonix Pharmaceuticals, Seth Lederman, M.D.
This HONOR study was completely randomized and was a placebo-controlled study. Patients were given a bedtime sublingual Tonmya 5.6mg or the placebo sublingual tables. The primary efficacy endpoint was the 12-week change from baseline in the severity of the PTSD symptoms as measured by the standardized CAPS-5.
The CAPS-5 is a standard structured clinical interview, and it currently serves as the standard in research that measures the severity of symptoms in patients with PTSD.
In addition to its Tonmya drug, Tonix is currently working on a bedtime treatment drug for agitation in Alzheimer’s disease, which is currently in its Phase 2 of its trial.
TNXP Stock Movement
According to Yahoo Finance, TNXP closed the market yesterday at $3.95 a share and opened the market at $0.89, opening the day down -77.46%. At press time, TNXP is trading at $1.35 a share, down -$2.60 (-65.82%).
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