Opexa Therapeutics (Opexa) has reported results from further analysis of the double-blind, placebo-controlled, 52-week phase IIb TERMS clinical study of 150 patients with Relapsing Remitting MS (RRMS).
The analysis evaluated patients with an annualised relapse rate of one or greater at study entry. More than 83% of the Tovaxin-treated group remained relapse free at one year and the annualised relapse rate after treatment decreased to 0.20, a 42% reduction compared to placebo.
The post-hoc analysis which represents 86% of the total patient population in the TERMS study was conducted to evaluate Tovaxin treatment among study patients with the same baseline disease activity that is being targeted for inclusion in the forthcoming phase IIb study.
Along with a marked reduction in relapses, 73% of the Tovaxin-treated patients with showed stabilization or improvement in MS disability, including 16.5% with a sustained improvement in the Expanded Disability Status Scale (EDSS) of at least one full point.
On MRI, the Tovaxin-treated group also has demonstrated a reduction in brain atrophy and fewer inflammatory brain lesions that progressed to black holes as compared to the placebo-treated group. Treatment with Tovaxin was well tolerated, with no serious adverse events reported in any Tovaxin-treated patient.
Dawn McGuire, neurologist and a member of clinical advisory board at Opexa, said: “The expanded analysis represents the MS patient population with active relapsing-remitting disease planned for recruitment into the next phase IIb trial of Tovaxin. Clinical benefits include not only reduction in relapses, but a surprising reversal of disability in over 16% of Tovaxin-treated patients. Along with MRI data suggesting a reduction in neuronal cell loss, these results raise the possibility that Tovaxin-treatment may have neuroprotective as well as disease-modifying effects. Tovaxin’s favorable safety profile and these early efficacy signals strongly support moving forward with a confirmatory phase IIb trial.”
“From an immunology perspective, the data generated thus far from the TERMS trial, from thousands of patient samples, appear to correlate nicely with the putative mechanism of action for Tovaxin. While additional analyses are still in progress, we are also seeing early associations between depletion of myelin reactive T-cells and favorable clinical outcomes.”