Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that the European Patent Office (“EPO”) issued European Patent No. 2968992 to the Company on December 11, 2019. This patent, “Eutectic Formulations of Cyclobenzaprine Hydrochloride and Mannitol,” includes 14 claims directed to compositions comprising eutectics of cyclobenzaprine hydrochloride and mannitol and methods of making those compositions. This patent is expected to provide Tonix with market exclusivity until 2034.
Seth Lederman, M.D., President and Chief Executive Officer of Tonix commented, “The issuance of this European patent is an important step forward in our efforts to broaden our intellectual property estate on a global basis for TNX-102 SL*.”
Tonix’s proprietary eutectic formulation of cyclobenzaprine, or TNX-102 SL, is designed for chronic sublingual (under-the-tongue) administration daily at bedtime, which the Company believes facilitates transmucosal absorption of cyclobenzaprine and bypasses first pass liver metabolism. Marketed cyclobenzaprine drug products are limited to short-term use (two to three weeks) and formulated for oral ingestion, which results in significant liver metabolism. Sublingual TNX-102 SL has a different pharmacokinetic profile than marketed oral cyclobenzaprine drug products. TNX-102 SL is being developed as a treatment for four indications: posttraumatic stress disorder (PTSD), fibromyalgia, agitation in Alzheimer’s disease and alcohol use disorder. Marketed oral cyclobenzaprine products are indicated for the relief of muscle spasm.
On December 10, 2019, Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced that the first patient was enrolled in the Phase 3 RELIEF study (TNX-CY-F304). RELIEF is a potential pivotal study of TNX-102 SL* (cyclobenzaprine HCl sublingual tablets) 5.6 mg, a non-opioid, centrally-acting analgesic, taken daily at bedtime for the management of fibromyalgia.
“Tonix is dedicated to improving the lives of the millions who suffer from fibromyalgia, and enrolling the first patient in the RELIEF study is an important step towards achieving this goal,” said Seth Lederman, M.D., Tonix’s President and Chief Executive Officer. “Our two prior randomized, double-blind, registration-quality studies of TNX-102 SL in fibromyalgia evaluated TNX-102 SL at 2.8 mg, whereas the RELIEF study will evaluate TNX-102 SL at the 5.6 mg dose. In the prior studies, TNX-102 SL 2.8 mg was well tolerated, and the most common side effect was transient tongue numbness in a subset of patients. RELIEF is an adaptive-design study for which the primary endpoint is change from baseline in mean pain. We believe the mechanism of action of TNX-102 SL is the improvement of sleep quality. We expect results from an unblinded interim analysis in the second half of next year and topline results in the first half of 2021 based on the currently-planned sample size.”
Supported by the previous safety and efficacy findings of TNX-102 SL in fibromyalgia and posttraumatic stress disorder (PTSD), Tonix believes that using the 5.6 mg dose of TNX-102 SL in the new Phase 3 RELIEF fibromyalgia study has the potential to provide clinical evidence to support the efficacy and safety of TNX-102 SL for the management of fibromyalgia. The registration of TNX-102 SL 5.6 mg for the fibromyalgia indication is expected to be supported by the long-term safety exposure data from the PTSD program for TNX-102 SL 5.6 mg. The active ingredient of TNX-102 SL, cyclobenzaprine, is not associated with a risk of addiction.