Tonix Pharmaceuticals reports positive topline trial outcomes of TNX-1500

 Tonix Pharmaceuticals has reported positive topline outcomes from its Phase I single ascending dose study of its crystallisable fragment (Fc)-modified humanised anti-CD40 ligand (CD40L) monoclonal antibody, TNX-1500, in healthy subjects.

The trial aimed to evaluate the tolerability, safety, pharmacodynamics, and pharmacokinetics of the intravenous form of the antibody, to support dosing for a subsequent Phase II trial in recipients of kidney transplants.

During the trial, TNX-1500 was administered intravenously to subjects at doses of 3mg/kg, 10mg/kg, and 30mg/kg for one hour.

Subjects were monitored for one day post-infusion and attended periodic clinic visits for up to 120 days.

To assess the therapy’s immune modulation potency, a Keyhole Limpet Hemocyanin (KLH) challenge was administered on day 2 and day 29.

Across three cohorts, 26 subjects were enrolled, and 24 completed the trial. The therapy demonstrated a ‘favourable’ tolerability and safety profile.

The pharmacokinetics analysis revealed that the half-life of the therapy varied with dosage, averaging 19.6 days at 3mg/kg, 37.8 days at 10mg/kg, and 33.7 days at 30mg/kg.

At higher doses, TNX-1500 blocked both primary and secondary anti-KLH antibody responses while the lowest dose blocked the primary response and reduced the secondary response.

Following these results, Tonix plans to engage with the US Food and Drug Administration (FDA) in an end-of-Phase I meeting to discuss the findings and seek alignment on the design of the Phase II study for kidney transplant recipients.

https://finance.yahoo.com/news/tonix-pharmaceuticals-reports-positive-topline-164304779.html