Tonix Pharmaceuticals has lost a U.S. Army agreement to develop TNX-102 SL in military-related post-traumatic stress disorder (PTSD). But it has gained the chance to persuade the FDA to retain the drug’s breakthrough status shortly after the agency rescinded the designation.
The U.S. Army Medical Materiel Development Activity (USAMMDA) entered into the cooperative R&D pact with Tonix in 2015 to expand efforts to assess a sublingual form of the long-approved muscle relaxant cyclobenzaprine in patients with PTSD linked to military service. In 2016, Tonix presented mixed phase 2 data in the indication. The larger, lower-dose cohort missed the primary endpoint.
Tonix moved into phase 3 on the strength of data from the higher-dose arm but is now set to lose the support of USAMMDA. In a financial regulatory filing published when the markets were closed Friday, Tonix said USAMMDA will terminate the pact without cause later this month.
News of the USAMMDA termination came shortly after Tonix said the FDA had rescinded the breakthrough status it granted TNX-102 SL, also known as Tonmya, in 2016 on the basis of the phase 2 data. The FDA cited emerging data from a phase 3 trial of TNX-102 SL, which was stopped last year due to inadequate separation from placebo, to justify the proposed rescinding of the status.
Tonix revealed the FDA had rescinded the breakthrough status at the start of March but has now gained a reprieve. As Tonix tells it, the FDA acknowledged that it should have met with the biotech to discuss additional data before pulling the breakthrough status. The upshot is TNX-102 SL has regained the status, for now.
The reprieve may be temporary. Tonix has a chance to make its case to the FDA at a meeting in June. After that, the FDA will decide whether to rescind the breakthrough status for TNX-102 SL or reverse course and allow it to retain its regulatory privileges.
Tonix expects to post top-line data from a second phase 3 PTSD trial in the first half of next year.