First Results for Phase IIa Data of UCB's Lacosamide for Treatment of Fibromyalgia
* Results in proof of concept trial encourage further analysis * Promising side effect profile observed
BRUSSELS, Belgium, June 24, 2008 at 18:00 CET - UCB announced today headline results based on first-line analyses of its Phase IIa clinical trial with lacosamide to treat fibromyalgia syndrome. The initial results from this proof of concept study showed activity of lacosamide in fibromyalgia syndrome but require further analysis. A decision to start Phase IIb will be made by the end of the year. This lacosamide trial was randomized, placebo-controlled and double-blind to assess efficacy and safety of 400mg/day lacosamide tablets in patients suffering from signs and symptoms associated with fibromyalgia syndrome (FMS). This trial was designed to establish a signal to provide justification for further clinical development of lacosamide in FMS.
The primary variable was a within-subject change in average daily pain score from baseline to the last two weeks of the treatment phase using an 11-point Likert scale. Based on 158 patients (randomized) of the full analysis set, an effect size of 0.5 in favour of lacosamide versus placebo was observed for the primary variable. Lacosamide was generally very well tolerated.
About Fibromyalgia Syndrome
Fibromyalgia is characterized by chronic widespread musculoskeletal pain, tenderness, fatique, sleep disorders, morning stiffness and is associated with a number of other symptoms such as cognitive dysfunction, mood disturbances, paresthesia, digestive disorders.
Lacosamide has a dual mode of action and is the first agent of its kind to be clinically studied for the treatment of fibromyalgia. It selectively enhances slow inactivation of sodium channels and interacts with the neuroplasticity-relevant target - collapsin-response mediator protein-2 (CRMP-2).
Lacosamide has been filed with the US FDA and the EMEA for the treatment of epilepsy and diabetic neuropathic pain. Further information Antje Witte, Vice-President Corporate Communications & Investor Relations, UCB Group
UCB, Brussels, Belgium is a global leader in the biopharmaceutical industry dedicated to the research, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diseases, immune and inflammatory disorders and oncology. UCB focuses on securing a leading position in severe disease categories. Employing around 12,000 people in over 40 countries, UCB achieved revenue of EUR 3.6 billion in 2007. UCB S.A. is listed on the Euronext Brussels Exchange.
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: June 2008