Shares of Tonix Pharmaceuticals were hammered early Monday after the biotech put out word that its lead drug had failed a Phase IIb study for fibromyalgia.
According to Tonix ($TNPX), TNX-102 SL flopped on the primary endpoint: a change in patients' daily pain score after 12 weeks. Investigators highlighted what they said were positive results for pain along with promising results for secondary endpoints measuring side effects like sleep disturbance, but investors weren't buying it. The New York-based biotech saw its shares plunge by 50% soon after the news hit.
Headed into the setback, Tonix had a market cap of only $147 million and looks like it will end the day well below that level. TNX-102 SL is a reformulated version of cyclobenzaprine, a muscle relaxer which is used in oral form to combat pain and stiffness in patients. Tonix has touted its sublingual formulation as a major improvement for patients and is also studying the drug for post-traumatic stress disorder.
Tonix's plan now? Head straight into a pivotal Phase III study.
"TNX-102 SL showed broad activity across key fibromyalgia symptoms in the BESTFIT study, and the treatment was well tolerated," says CEO Seth Lederman in a statement. "While the study did not achieve statistical significance on the primary endpoint, this is a very supportive study for the Phase III clinical program. Also, these findings validate our approach to develop a differentiated drug that acts beyond analgesia to improve multiple symptom domains of a complex condition."
Lederman told FierceDrugDelivery recently that he was anticipating a 2017 approval for this treatment. Investors may be recalculating that timeline today.
- here's the release