MarcoPolo Pharmaceuticals has announced results from interim analysis of the clinical study: "Double-blind, placebo-controlled clinical study to evaluate the efficacy, safety and tolerability of a fixed dose of VLB-01 as adjunctive therapy in patients with partial seizures (phase II-III)".
VLB-01 has shown significant clinical and statistical results in phase II-III study in patients suffering from complex partial seizure secondary generalized or not which were not stabilized despite current antiepileptic treatment. This was a randomized double blind placebo controlled study with 2 weeks titration and 12 weeks maintenance treatment. VLB-01 in dose 1500mg/day was very well tolerated and there were no safety issues reported from the trial. The efficacy was clinically and statistically significant with median percent seizure reduction of about 60% for VLB-01, three times above the placebo (p<0.0001). Similarly the response rate was about two times for VLB-01 compared to placebo. The rate of seizure-free patients ranged from 19 to 33% for VLB-01 compared to 10 to 17% for placebo.
VLB-01 belongs to a new pharmacological class: a Melatonin III (NRH: quinone oxidoreductase 2) receptor modulator of which VLB-01 is the first one tested in human. Although the mode of action is not fully elucidated, pre-clinical evidence support that VLB-01 could have a disease modifying effect through neuroprotective proprieties.
"These are very promising results. Treatment resistant epilepsy is a devastating disease and despite intense research the unmet need remains very high. We are glad that VLB-01 could contribute to help patients with such severe condition. Our company is dedicated to pursue the effort and make VLB-01 available to patients at the earliest", said Prof. Mondher Toumi, Chief Executive Officer.
Dr Alexander Bakhutashvili, Chief Medical Officer, added: "It is a great achievement with our second programme reaching a positive clinical proof of concept. We are committed to have this product approved in the Russian Federation for the end of this year or early next year. We expect the product to be a true break-through-therapy for those patients awaiting new therapy to help stabilizing their epileptic condition".