Tonix Pharmaceuticals announced positive topline results from its Phase 1 single ascending dose trial of TNX-1500, an anti-CD40L monoclonal antibody, in healthy participants. The trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500 to inform dosing for a planned Phase 2 trial in kidney transplant recipients. The results support the continuation of TNX-1500 development for the prevention of kidney transplant rejection.
This positive Phase 1 data is important because it validates the potential of TNX-1500 as a next-generation anti-CD40L mAb with an improved safety profile compared to first-generation treatments like ruplizumab, which were hampered by thrombotic risks. The findings suggest TNX-1500 could offer a more effective and safer approach to preventing transplant rejection, potentially improving long-term graft survival and reducing the toxicity burden associated with current immunosuppressive regimens. This represents a critical step towards addressing the ongoing need for better transplant rejection prevention strategies.
In the Phase 1 trial, TNX-1500 blocked primary and secondary antibody responses to a test antigen at doses of 10 mg/kg and 30 mg/kg. The drug exhibited a mean half-life of 34-38 days at these doses, supporting a convenient monthly dosing regimen for future trials. TNX-1500 was generally well-tolerated, with no serious adverse events or thromboembolic events observed. Importantly, the only treatment-emergent adverse event occurring in three or more participants was mild aphthous ulcers, which resolved quickly.
These results pave the way for Tonix to engage with the FDA and plan a Phase 2 efficacy study in kidney transplant recipients. The positive safety and pharmacodynamic data suggest TNX-1500 holds promise as a potential best-in-class therapy for preventing organ rejection and treating autoimmune diseases, representing a significant advancement in the field of transplantation and immunology.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
