Tonix tanks on a Phase II flop for its headache drug

Tonix CEO Seth Lederman

Tonix Pharmaceuticals ($TNXP) is ditching an in-development therapy for chronic headaches after the drug missed its main goals in Phase II, sending the biotech's share price plunging.

The drug, TNX-201, failed to significantly beat out placebo in episodic tension-type headache, missing its primary endpoint of relieving pain within two hours of dosing. Tonix's therapy also failed to make a meaningful difference on pain as measured by the Visual Analog Scale, the company said.

The results sent Tonix's share value down more than 35% on Tuesday, as TNX-201's failure effectively cuts the company's pipeline in half.

The New York-headquartered Tonix had planned to build the case for TNX-201 as a nonaddictive treatment for headache, hoping to establish proof of concept in episodic tension-type headache, most commonly treated with barbiturates, and then expand the drug's scope from there. The company recruited 147 patients in its Phase II study, giving half a single 140-mg dose of TNX-201 and the rest placebo.

"These results are disappointing, but we designed the study to challenge our hypothesis rapidly and with minimal capital investment," Tonix CEO Seth Lederman said in a statement. "We are satisfied that we achieved a definitive outcome."

Now Tonix is scrapping the program altogether, shifting its focus to the late-stage TNX-102 SL. That drug is now progressing through a Phase III trial in fibromyalgia with data expected in the third quarter, Tonix said. The company moved TNX-102 SL, a sublingual pill, into late-stage development despite its missing the primary endpoint in a Phase IIb trial.

TNX-102 SL is also in the midst of a Phase II post-traumatic stress disorder study that the company believes could form the basis for a regulatory approval, with data expected next quarter.

- read the statement

Read more on