Tonix tanks after Phase III failure

pharmafile | September 7, 2016 | News story | Research and Development PTSD, fibromylagia, phase III failure, tonix, tonix pharmaceuticals 

New York-based Tonix Pharmaceuticals has suffered an almost 60% fall in their share price, after the announcement that its fibromyalgia drug candidate, TNX-102 SL, failed to significantly reduce pain in a Phase III trial.

Fibromyalgia is a disorder that stems from the central nervous system and is characterised by widespread pain, non-restorative sleep, fatigue, and disability. TNX-102 SL is designed to deliver cyclobenzaprine to the bloodstream rapidly when taken under the tongue. It has antagonist activities at the serotonin-2A, alpha-1 adrenergic and histamine H1 receptors. It is also under investigation for the treatment of post-traumatic stress disorder (PTSD).

In the AFFIRM trial, the trial drug did not achieve statistical significance in the proportion of patients who reported a 30% or greater reduction in pain from baseline to the end of the 12-week treatment period. Tonix do point out, however, that TNX-102 SL did show improvements when analysed by other standard statistical approaches. It also showed strong effects on improving sleep quality.

Furthermore, Tonix points to an “unexpected imbalance in patient discontinuations” from the study created a “negative bias” as any patient who left early was labelled a non-responder.

CEO Seth Lederman says: “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 programme.

“Well will therefore discontinue the fibromyalgia programme in order to fully focus Tonix’s resources on advancing our potential breakthrough PTSD programme to Phase III.”

These reassurances were not enough to appease investors however, with the share price of Tonix now under $1. The company has cash and equivalents of about $31.2 million as of June 30. If their share price is to make a resurgence, it will have to wait quite a while. The late-stage study for TNX-102 SL in PTSD will only start in Q1 2017 at the earliest.

Sean Murray

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