Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) shares jumped on Monday after the firm announced the expansion of its late-stage post-traumatic stress disorder (PTSD) treatment.
Specifically, the firm announced the expansion of the TNX-102 SL (Tonmya) 5.6 mg program beyond PTSD to include Phase 3 development for Tonmya in fibromyalgia. This is Tonix’s lead Phase 3 program in PTSD, with the Phase 3 Recovery trial actively enrolling military and civilian PTSD participants.
In a recent clinical guidance meeting with the U.S. Food and Drug Administration (FDA), Tonix received clear guidance and support to advance the development of Tonmya for the management of fibromyalgia.
A lower dose of TNX-102 SL (2.8 mg) taken daily at bedtime was studied previously in fibromyalgia in Phase 2 and Phase 3 studies. Both studies showed clinical benefits, especially in the quality of sleep improvement. However, primary analyses on pain reduction were not statistically significant.
Note that there were no serious or unexpected adverse events reported. The most common adverse events were mostly related to local administration site reactions, such as oral hypoaesthesia and abnormal product taste.
Seth Lederman, M.D., Tonix’s president and CEO, commented:
We are very pleased with the outcomes of our recent discussion with the FDA to advance the fibromyalgia Phase 3 clinical program with TNX-102 SL 5.6 mg with the potential to expand the product labeling beyond PTSD. The FDA’s acceptance of the well-established safety information of currently-marketed oral cyclobenzaprine products and their agreement that TNX-102 SL 5.6 mg long-term exposure data from our PTSD studies may support the fibromyalgia indication are very reassuring. We are looking forward to submitting a final Phase 3 protocol and statistical analysis plan for FDA acceptance prior to study initiation. We have extensive clinical experience and data collected over the past seven years with TNX-102 SL in fibromyalgia and PTSD studies. In addition to the synergy between these two development programs, we are very pleased with the FDA’s clear guidance and support to help advance our lead product candidate, TNX-102 SL, in fibromyalgia and PTSD toward NDA approvals.”
Shares of Tonix were last seen up more than 16% at $2.72, in a 52-week range of $0.36 to $9.60. The consensus price target is $14.00.