UCB ANNOUNCES POSITIVE DATA ON EPILEPSY DRUGS

UCB has disclosed positive Phase II clinical data on brivaracetam and seletracetam in the adjunctive treatment of partial onset seizures in epilepsy.

Two Phase IIb dose-finding studies were conducted with brivaracetam in epilepsy, testing a dose range of 5 to 150 mg/day. A trial (N01193) evaluating the efficacy and safety of brivaracetam (5, 20 and 50 mg per day) in the adjunctive treatment of adult patients (16-65 years) with refractory partial onset seizures, with or without secondary generalization, met its primary endpoint. Brivaracetam was shown to reduce seizure frequency over placebo in patients with partial onset seizures that were not fully controlled despite treatment with one or two concomitant anti-epileptic drugs. At a dose of 50 mg per day, brivaracetam reduced seizure frequency by 53 percent compared with a 22 percent seizure reduction with placebo.

A second Phase II study (N01114) confirmed efficacy at 50 mg of brivaracetam per day with the higher dose evaluated (150 mg per day) not conferring added efficacy. At a dose of 50 mg per day, brivaracetam reduced seizure frequency by 38 percent compared with a 19 percent seizure reduction with placebo. Both studies included patients who were not controlled by Keppra, therefore brivaracetam may provide benefits to patients who have failed on Keppra.

Additionally, two Phase IIa dose-exploration studies were conducted with seletracetam in epilepsy (N01191 and N01192) evaluating the efficacy and safety of seletracetam in the adjunctive treatment of partial onset seizures in highly refractory adult patients currently receiving up to three concomitant anti-epileptic drugs. Study N01192 specifically evaluated the efficacy and safety of seletracetam in patients experiencing partial onset seizures while receiving Keppra as one of the concomitant drugs. In both studies, similar efficacy was observed with seletracetam reducing seizure frequency by approximately 40 percent from baseline. Efficacy was demonstrated in very refractory patients, including patients failing on Keppra.