Tonix Pharmaceuticals begins enrollment in Phase 2 bone health study

Tonix Pharmaceuticals has enrolled the first participant in an investigator-initiated Phase 2 study of TNX-1900 for improving bone health in children with autism spectrum disorder, named the BOX study, at Massachusetts General Hospital. The aim of this Department of Defense-funded study is to investigate the efficacy and safety of TNX-1900 as a novel therapeutic agent to increase bone density and improve bone structure and strength in children with ASD. Tonix is providing active drug and placebo for the BOX study as part of a drug donation agreement with MGH. MGH is the sponsor of the trial, which is being conducted under an investigator-initiated investigational new drug application. The Phase 2 BOX study is a study to evaluate the effects of twice daily administration of TNX-1900 on bone measures in children with ASD. The primary endpoint is the difference between TNX-1900 compared to placebo groups in 12-month change in whole body less head bone mineral density Z-scores. A Z-score compares one’s bone density to the average bone density of age and gender matched controls.