TissueTech, parent company to Amniox Medical, received FDA clearance to commence a dosing study using its Investigational New Drug TTAX03 to treat facet joint pain resulting from osteoarthritis (OA). FDA clearance of this application represents one of the first steps in commercializing TTAX03-FJ as a biologic.
This Phase I randomized, double-blinded, placebo-controlled, dose-finding study will include one-year follow-up to assess TTAX03's long-term safety and potential lasting benefit.
Earlier studies using Amniox's Cryopreserved Amniotic Membrane and Cryopreserved Umbilical Cord particulate CLARIX® FLO have shown the ability to treat joint pain resulting from moderate to severe knee OA.
TissueTech's CAM and CUC products are being investigated as biologics for several different indications, given their long history of safe use and the known anti-inflammatory, anti-scarring and pro-regenerative properties of birth tissue.
"We believe that TTAX03 will prove to be successful as a non-opioid intra-articular treatment for moderate to severe lower back pain resulting from facet joint osteoarthritis," said TissueTech President and Chief Executive Officer Amy Tseng. "We are committed to positively impacting patients' lives and think this product could provide dramatic outcomes for patients who suffer from facet joint OA. Low back pain not only affects one's quality of life but has also been shown to contribute to opioid and other substance abuse disorders. We are hopeful this product will be able to help these patients before they become dependent on such medications."