UCB (BE) - UCB announces first results from Phase III brivaracetam studies in epilepsy
* One study met its primary efficacy endpoint while the second study did not meet its primary efficacy endpoint * A third safety and tolerability study confirmed brivaracetam was well tolerated * Further analysis will be conducted and regulatory authorities will be consulted to determine next steps to bring brivaracetam to patients
Brussels (Belgium), 28 April 2009 - 07:00 am (CEST) - press release, regulated information - UCB announced today top-line results from two Phase III clinical studies to assess the efficacy and safety of brivaracetam as adjunctive treatment of partial-onset seizures in adults with epilepsy. Results were also announced for a third well-controlled safety and tolerability study.
Study N01253 achieved statistical significance in its primary efficacy endpoint, showing that adjunctive treatment with brivaracetam was associated with significant reductions in seizure frequency versus placebo. Study N01252 did not achieve statistical significance on the primary efficacy endpoint. Data from all three studies (N01252/1253/1254) confirmed that brivaracetam was generally well tolerated, with the majority of adverse events reported being mild to moderate in nature.
"Further analysis of both the primary and secondary endpoints of these Phase three studies is needed to better understand the potential of the drug," said Prof. Dr. Iris Löw-Friedrich, Chief Medical Officer of UCB. "Upon first analysis of the Phase three studies, the efficacy observed appears to differ between different patient subpopulations. We need to complete our review of all relevant data and will decide our next steps to bring brivaracetam to patients, after consulting with regulatory authorities."
Nearly 1,300 epilepsy patients, aged between 16 and 70 years, took part in the three multicentre, multinational Phase III studies. The studies were undertaken following promising efficacy and tolerability data for brivaracetam in the Phase IIb program. Two randomized, double-blind, placebo-controlled studies were designed to evaluate the efficacy and safety of adjunctive brivaracetam (5, 20 and 50 mg/day or 20, 50 and 100 mg/day) over 12 weeks in patients with partial-onset epilepsy, not fully controlled despite treatment with one or two other antiepileptic drugs. The third study was a randomized, double-blind, placebo-controlled trial with flexible dosing designed to evaluate the safety and tolerability of brivaracetam over 16 weeks in patients with uncontrolled partial onset or primary generalised seizures, not fully controlled despite treatment with one to three other antiepileptic drugs. All ongoing clinical trials with brivaracetam are continuing.
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About UCB UCB, Brussels, Belgium (www.ucb.com<http://www.ucb.com>) is a biopharmaceutical company dedicated to the research, development and commercialization of innovative medicines with a focus on the fields of central nervous system and immunology disorders. Employing approximately 10 000 people in over 40 countries, UCB generated revenue of 3.6 billion euro in 2008. UCB is listed on Euronext Brussels (symbol: UCB).
Forward looking statement This press release contains forward-looking statements based on current plans, estimates and beliefs of management. Such statements are subject to risks and uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking statements contained in this press release. Important factors that could result in such differences include: changes in general economic, business and competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuations and hiring and retention of its employees.
Posted: April 2009