Shares in Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) halved as the company revealed a Phase 3 study of its TNX-102 SL nerve pain treatment was a bust.
Data from the study did not achieve statistical significance in the primary efficacy endpoint, but it did show statistically significant effects on pain when analysed by other standard statistical approaches.
The internal consistency of these results provides clear evidence of the beneficial effect of TNX-102 SL for the treatment of nerve pain or fibromyalgia, Tonix claimed.
"TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms and was well-tolerated in the AFFIRM study. Despite achieving clinically meaningful results from AFFIRM, we have greater clarity on the regulatory path forward in our PTSD [post-traumatic stress disorder] programme. We will therefore discontinue the fibromyalgia program in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD programme to Phase 3. We owe it to our investors, and to patients who are waiting for meaningful clinical innovation, to steward our resources effectively,” said Seth Lederman, president and chief executive officer of Tonix.
Shares in Pharmaceuticals crashed to US$1.06 from US$2.18 at Friday’s close. Year-to-date the shares have shed 86%.