Brussels (Belgium), 10 January 2011 — UCB today announced that four major clinical development milestones have been achieved as planned plus one ahead of schedule during the fourth quarter of 2010.
A new Phase III study evaluating brivaracetam as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy has commenced with the first patient first visit recorded in December 2010.
It is a randomized, double-blind, placebo-controlled, multicentre, parallel-group study with more than 700 patients to evaluate the efficacy and safety of brivaracetam 100 mg/day and 200 mg/day on seizure frequency.
The headline results are expected in the first half 2013.
UCB also initiated a Phase III clinical study across Europe to evaluate the efficacy and safety of Vimpat® (lacosamide) (200 to 600 mg/day) as monotherapy in adult patients newly or recently diagnosed with epilepsy and experiencing partial-onset seizures or generalized tonic-clonic seizures.
It is a multicenter, double-blind, double-dummy, randomized study comparing lacosamide (200mg to 600mg/day) with carbamazepine controlled release (400mg to 1200mg/day).
The non-inferiority design is intended to show at least a similar benefit-risk balance between lacosamide and carbamazepine controlled release.
The headline results for this trial are expected by the end of 2014.
The first results from the Phase II programme investigating Vimpat® as adjunctive therapy in children aged two to 17 years with uncontrolled partial-onset seizures are now available.
The profile for lacosamide in children aged five to 11 years is similar to that observed in healthy adults.
No evidence for dose dependent increase in treatment related adverse events and no clinically relevant changes observed in laboratory values and vital signs.
Data from this study were used to determine the dose range for the subsequent paediatric studies being performed.
In December 2010, UCB announced the enrollment of the first patient into its Phase III programme (EMBODY™ 1 and EMBODY™ 2) for epratuzumab in patients with moderate to severe systemic lupus erythematosus (SLE).
Recruitment is ongoing with approximately 780 subjects randomized in each study to be recruited.
First results are expected in the first half 2014.
A Phase IIb programme for CDP6038 (anti-IL 6) being developed for the treatment of moderate to severe rheumatoid arthritis started ahead of plan with first patients recruited and multiple study sites now active.
It is a randomized, double-blind placebo-controlled, dose ranging study in more than 200 patients with an active comparator 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.