Tonix exhumes positive take on data from phase 3 flop

Tonix CEO Seth Lederman (Barryfc101/CC BY-SA 4.0)

Tonix Pharmaceuticals has dug into the data from its failed phase 3 post-traumatic stress disorder trial and emerged with a positive spin on the flop. The biotech hit upon the upbeat interpretation by separating out the results from patients who suffered the trauma at the root of their PTSD within the past nine years. 

In this subgroup, Tonix’s sublingual formulation of cyclobenzaprine, TNX-102 SL, bested placebo on a scale of PTSD, but only just. The subgroup analysis had a p value of 0.039. TNX-102 SL performed no better than placebo in patients whose trauma occurred more than nine years ago. An analysis of an earlier phase 2 found no divergence between the performance of the two groups in that trial.

The subgroup analysis led Tonix to conclude TNX-102 SL has a future in some patients, although it is yet to provide much evidence to explain why efficacy would decline or why nine years would be a tipping point.


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“The finding that treatment response to Tonmya in P301 decreases as the time since trauma gets longer, suggests that military service members and veterans with PTSD are transitioning from a Tonmya-treatment responsive state to a non-responsive state after approximately nine years,” Tonix CEO Seth Lederman, M.D., said in a statement.

Tonix wants to use the subgroup analysis to justify further development of TNX-102 SL in patients who suffered trauma in the past nine years but will need to get financial backers to buy into the idea. The biotech closed out June with $16.7 million in the bank. And its stock has been in the doldrums since the phase 3 failure wiped 70% off its value. 

The early response to the subgroup analysis suggests Tonix’s positive spin may enable it claw back some of its lost value. Shares in the biotech rose 19% in premarket trading following the news.

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