UCB announces top-line phase 2 results for olokizumab in rheumatoid arthritis
Olokizumab improved rheumatoid arthritis in disease activity score significantly over placebo
Olokizumab and the active comparator demonstrated comparable efficacy
Brussels, 26 September 2012, 6 pm CEST–regulated information – UCB announced today the top-line results from a phase 2b study of olokizumab (CDP6038) in adult patients suffering from rheumatoid arthritis (RA) having previously failed anti-TNF therapy. The primary objective of this study was to evaluate the efficacy of various doses and dose administration frequencies of olokizumab relative to placebo.
This phase 2b study met its primary endpoint of demonstrating a significant reduction in the disease activity score at week 12 across all olokizumab dose groups relative to placebo. All doses of olokizumab demonstrated statistically significant improvement in disease activity score (DAS 28) (p<0.001) when compared with placebo.
In addition, this study included an active comparator arm (tocilizumab). The exploratory analyses of these data suggest that olokizumab and tocilizumab demonstrated comparable efficacy, as measured by DAS scores in this difficult to treat population. Olokizumab was well tolerated across all doses and demonstrated a safety profile comparable to tocilizumab and consistent with known effects of IL-6 inhibitors.
"UCB is committed to developing new therapies offering breakthrough innovation to people living with severe diseases. We are very satisfied that the first results for the primary endpoint confirm our data models. However, our current data do not suggest sufficient differentiation potential versus the active comparator," says Ismail Kola, President of UCB New Medicines, UCB's research and early development division."We are now exploring appropriate options for olokizumab, including partnering. At UCB, we strive constantly to allocate our funds and resources to our very promising late and early pipeline projects in immunology and neurology."
The three-months trial was a randomized, double-blind, placebo-controlled, dose ranging study with an active comparator (tocilizumab) to evaluate the efficacy and safety of olokizumab (CDP6038) administered subcutaneously for 12 weeks. Approximately 220 patients with moderately- to severely-active RA who had an unsuccessful response to previous anti-TNF therapy were enrolled in the study. The treatment arms for olokizumab evaluated 60, 120 and 240 mg administered subcutaneously, every two weeks or every four weeks. In the active comparator arm, 8 mg/kg tocilizumab was administered intravenously every four weeks. All patients received concomitant methotrexate treatment.
Further analyses are on-going and detailed results of this study will be submitted to an appropriate future medical congress.
For further information
Antje Witte, Investor Relations UCB
T +32.2.559.9414, [email protected]
France Nivelle, Global Communications, UCB
T +32 2 559 9178, [email protected]
Laurent Schots, Media Relations, UCB
T +32.2.559.9264, [email protected]
Notes to the editor
Olokizumab is a humanized monoclonal antibody targeting the IL-6 cytokine. IL-6 is involved in several autoimmune and inflammatory pathways. Olokizumab is the first of a new type of IL-6 inhibitor that selectively blocks the final assembly of the IL-6 receptor signaling complex.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8,000 people in about 40 countries, the company generated revenue of EUR 3.2 billion in 2011. UCB is listed on Euronext Brussels (symbol: UCB).
UCB Forward-Looking Statement
This press release contains forward-looking statements based on current plans, estimates and beliefs of management. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, political, regulatory or clinical results and other such estimates and results. By their nature, such forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions which could cause actual results to differ materially 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, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, product liability claims, challenges to patent protection for products or product candidates, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws and hiring and retention of its employees. UCB is providing this information as of the date of this press release and expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report a change in its expectations.
There is no guarantee that new product candidates in the pipeline will progress to product approval or that new indications for existing products will be developed and approved. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to differences between the partners. Also, UCB or others could discover safety, side effects or manufacturing problems with its products after they are marketed.
Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement.