Tonix Pharmaceuticals is enrolling participants in a Phase 3 trial for fibromyalgia, the RALLY study.
For more information, please visit www.RALLYStudy.com or www.clinicaltrials.gov (NCT04508621).
June 16, 2021 • 7:00 AM EDT
Read moreTonix's lead product candidate, TNX-102 SL, is being developed for the treatment of fibromyalgia.
View Pipeline2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting
Our experienced team has a strong track record of success in drug approvals and value creation.
View ManagementAt Tonix, we are focused on identifying and developing candidates that have the promise to treat and prevent human disease and alleviate suffering. Through our own development, in-licensing, collaborations and acquisitions we are curating an innovative and effective portfolio that targets the relief of pain, and attenuates infection. Currently, our pipeline is primarily comprised of central nervous system (CNS) and immunology product candidates. We are progressing small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions through our CNS portfolio. Our immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases.
Our lead CNS candidate, TNX-102 SL1 (sublingual formulation of cyclobenzaprine) is in mid-Phase 3 development for the management of fibromyalgia, a disorder characterized by chronic musculoskeletal pain, sleep deprivation, fatigue and mood changes. In December 2020, we reported positive data in the Phase 3 RELIEF study, which evaluated TNX-102 SL for the management of fibromyalgia. The Company expects interim data for the second Phase 3 study, RALLY, in the third quarter of 20212 and topline data in the fourth quarter of 2021. TNX-102 SL is also in clinical stages for PTSD, agitation in Alzheimer’s disease (AAD) and alcohol use disorder (AUD).
Tonix’s lead vaccine candidate, TNX-18003 , is a live replicating vaccine based on our proprietary synthetic horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. We expect efficacy data from animal studies of TNX-1800 in the first quarter of 2021. TNX-8013, our live horsepox viral vaccine is in development to protect against smallpox and monkeypox.
1TNX-102 SL is an investigational new drug and has not been approved for any indication.
2Pending submission and agreement from FDA on statistical analysis plan.
3TNX-1800 and TNX-801 are investigational new biologics and have not been approved for any indication.
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