UCB achieves major clinical development milestones

UCB has initiated a new Phase III study assessing brivaracetam as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.

The randomised, double-blind, placebo-controlled, multicentre, parallel-group study with more than 700 patients is designed to evaluate the efficacy and safety of brivaracetam 100mg/day and 200mg/day on seizure frequency.

The headlines results of the study are expected in the first half 2013.

UCB has also initiated Phase III clinical study across Europe designed to assess the efficacy and safety of Vimpat (lacosamide) (200 to 600mg/day) as monotherapy in adult patients newly or recently diagnosed with epilepsy and experiencing partial-onset seizures or generalized tonic-clonic seizures.

The multicentre, double-blind, double-dummy, randomised study will compare lacosamide (200mg to 600mg/day) with carbamazepine controlled release (400mg to 1200mg/day).

The non-inferiority design is intended to demonstrate at least a similar benefit-risk balance between lacosamide and carbamazepine controlled release.

The study’s headline results are expected by the end of 2014.

The first results from the Phase II programme evaluating Vimpat as adjunctive therapy in children aged 2 to17 years with uncontrolled partial-onset seizures are now available.

The profile for lacosamide in children aged 5 to 11 years was similar to that observed in healthy adults.

There was no evidence of dose dependent increase in treatment related adverse events and no clinically relevant changes were observed in laboratory values and vital signs.

In December 2010, UCB has enrolled its first patient into its Phase III programme for epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE).

Recruitment is underway with approximately 780 subjects randomised in each study to be recruited.

First results are expected in the first half 2014.

A Phase IIb programme for CDP6038 (anti-IL 6), which is being developed for the treatment of moderate to severe rheumatoid arthritis, started ahead of schedule with first patients recruited and multiple study sites now active.

The randomised, double-blind placebo-controlled, dose ranging study will enroll more than 200 patients with an active comparator and is designed to evaluate the efficacy and safety of CDP6038 administered subcutaneously for 12 weeks to patients with active rheumatoid arthritis having previously failed TNF blocker therapy.

The headline results are expected in the third quarter 2012.