[7] In October 2021, Tonix announced the acquisition of a 48,000 square foot research and development center in Frederick, Maryland to support the Company's infectious disease pipeline.
[13] Some people also report restless legs syndrome, bowel or bladder problems, numbness and tingling and sensitivity to noise, lights or temperature.
[12] Tonix announced in September 2020 their plan to complete the Phase 3 RELIEF study of TNX-102 SL, a sublingual formulation of cyclobenzaprine, for management of fibromyalgia with currently enrolled participants.
[17] and in December 2020, the company announced top-line data results from the RELIEF Phase 3 trial that showed that TNX-102 SL safely and effectively eased pain and fatigue in people with fibromyalgia while also improving their sleep.
In December 2023, Tonix announced topline results of the Phase 3 RESILIENT study, reporting that the trial met its primary endpoint, significantly reducing daily pain compared to placebo.
[20][21] In January 2024, Tonix announced that the U.S. Food and Drug Administration (FDA) had conditionally accepted the trade name, Tonmya, for TNX-102 SL for the management of fibromyalgia.
Evidence suggests that oxytocin may reduce food intake by acting on neural pathways involved in reward and impulse control, processes believed to be dysregulated in BED.
[25] In March 2022, Massachusetts General Hospital and Tonix Pharmaceuticals announced a research collaboration to initiate Phase 2 trials to investigate TNX-1900* in treatment for BED.
This 8-week randomized, double-blind, placebo-controlled study aims to recruit 60 patients with BED and obesity and plans to evaluate whether TNX-1900 reduces bingeing frequency and body weigh.
[33] A Phase 3 trial of military-related PTSD began in February 2017, but was stopped in July 2018 after an interim analysis of 50% of target participants were evaluated, for "inadequate separation on primary efficacy endpoint".
[34] In March 2020, a later Phase 3 trial of TNX-102 SL for PTSD in from mostly civilian traumas also showed futility at an interim analysis of 50% of its target participants patients were evaluated and enrollment was discontinued.
[39] In September 2020, Tonix Pharma hosted and participated in a virtual webinar with Merck & Co. and IAVI to discuss the potential of T Cell Immunity in offering protection from COVID-19 infection.
In November 2020, Tonix announced preliminary, preclinical results in which non-human primates vaccinated with TNX-1800 manifested "takes" (skin reaction) associated with functional T cell immunity.
[45] Additionally, as of February 2023, Tonix has obtained an exclusive license from Columbia University for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prophylaxis of SARS-CoV-2 infection.
[46] Earlier in 2022, Tonix announced results from a retrospective observational study of over 50,000 Long COVID patients, which found that approximately 40% had fibromyalgia-like multi-site pain.
[47] In July 2017 the news division of the journal, Science, reported that Tonix had sponsored research and collaborating with scientists at the University of Alberta, David Evans and Ryan Noyce, and that the work had led to the generation of an extinct horsepox virus using synthetic biology—the lab had bought pieces of DNA from a reagent company and had built the horsepox genome with them.
[65] In August 2022, Tonix received a federal grant from the National Institute on Drug Abuse (NIDA), to support development of TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v.
[66] In January 2021, Tonix announced a second collaboration with Massachusetts General Hospital to work on TNX-1500, a monoclonal antibody targeting CD40-ligand with a focus on organ rejection in kidney transplantation.
[67] In August 2019, Tonix announced the signing of the first research collaboration agreement with Massachusetts General Hospital to develop TNX-1500, a humanized monoclonal antibody (mAb) that targets CD154 for the prevention and treatment of organ transplant rejection.
[70][71] Currently, Tonix has a sponsored research agreement with Boston Children's Hospital to study TNX-1500 for the prevention of graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT) in animals.
[74] In February 2021, Tonix announced that it had licensed technology from the French National Institute of Health and Medical Research (Inserm) to treat the rare genetic disorder Prader-Willi Syndrome.
[82] The following month Tonix began a research collaboration with Columbia University to study recombinant trefoil factor 2-based therapy TNX-1700 for the treatment of gastric and colorectal cancers.