Brussels (ots/PRNewswire) -
- Bimekizumab is a highly selective monoclonal antibody that inhibits
the activity of both IL-17A and IL-17F, key pro-inflammatory
cytokines expressed in several inflammatory diseases,
- In this early proof of concept study, bimekizumab showed fast and
sustained efficacy on disease activity measures in both skin and
joints and was well-tolerated
UCB today presented results from a Phase 1B study evaluating pharmacokinetics, safety, tolerability and preliminary efficacy of multiple doses of bimekizumab in patients with psoriatic arthritis (PsA) who had inadequate responses to at least one disease-modifying anti-rheumatic drug (DMARD) and/or one biologic. A total of 52 patients were randomized to receive either bimekizumab (N=38) or placebo (N=14). In the Phase 1B study with a limited patient and exposure set, bimekizumab showed fast and sustained efficacy on disease activity measures in both skin and joints and was well-tolerated. These findings were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London, England (8th - 11th June 2016).
(Logo: http://photos.prnewswire.com/prnh/20160607/376307LOGO )
"These data strengthen our understanding of bimekizumab and how its unique mechanism of action, which inhibits both IL-17A and IL-17F cytokines, could provide clinical benefits to patients living with immunological diseases such as PsA," said Dominique Baeten, M.D., Ph.D., Professor at the Department of Clinical Immunology and Rheumatology of the Academic Medical Centre/University of Amsterdam. "PsA is a very serious disease with a broad range of symptoms, including swelling and pain in the joints, which can significantly impact a patient's life. While we've seen advancements in the treatment of PsA with the introduction of biologics, it's crucial that we keep looking for newer and potentially better ways to control this devastating condition, especially in patients who aren't responding to existing therapies."
Psoriatic arthritis affects approximately 0.3% to 1% of the population and is primarily characterized by joint and skin manifestations, with patients typically experiencing a combination of both psoriatic and arthritic symptoms causing skin and nail abnormalities and progressive, disabling joint damage and reduced quality of life., New treatment options are needed for this serious disease.
Bimekizumab is an investigational humanized IgG1 monoclonal antibody specifically designed to potently and selectively inhibit the biological function of both IL-17A and IL-17F, which are key pro-inflammatory cytokines involved in chronic inflammatory processes driving the pathophysiology of many severe diseases including skin and joint disorders, like PsA.,
"The results of this study demonstrate the potential of bimekizumab for patients living with PsA, who are in constant need for new treatment options that can target uncontrolled inflammation and suppress both the difficult joint and skin-related symptoms they experience," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB, Immunology Patient Value Unit, UCB. "With these study results, we can now confidently focus on progressing the bimekizumab clinical program and look forward to extending our robust immunology pipeline as part of our continued commitment to bringing more targeted treatment options to this patient community."
The study evaluated multiple doses of bimekizumab compared to placebo for safety, tolerability, and efficacy, as measured by Psoriasis Area and Severity Index (PASI) and American College of Rheumatology (ACR) score. Bimekizumab demonstrated fast onset of response for both skin and joints with ACR20 response rates (RR) of 80% for the top 3 pooled doses (n=30) compared to a response rate of 17% in the placebo group (n=12) by Week 8. Additionally, findings showed a PASI90 RR of 87% (n=15) for patients receiving the top three doses of bimekizumab versus 0% (n=5) in the placebo group. Using a Bayesian statistical analysis, there was high posterior probability (>99%) that the ACR20 RR of bimekizumab at Week 8 was greater than those reported for current standard of care biologic treatments, including anti-IL-17A therapies. All doses of bimekizumab were well-tolerated. No treatment-related serious adverse events (AEs) were reported and there were no treatment-related discontinuations.
Bimekizumab is an investigational monoclonal antibody specifically designed to potently and selectively inhibit the biological function of both IL-17A and IL-17F, two key pro-inflammatory cytokines. IL-17A and IL-17F are involved in chronic inflammatory processes that drive many severe skin and joint diseases. It is planned that dose-ranging studies for bimekizumab will start this year. Bimekizumab is not approved by any regulatory authority worldwide.
1. Johansen et al. Characterization of the interleukin-17 isoforms
and receptors in lesional psoriatic skin. Br J Dermatol.
2. Van Baarsen et al. Heterogeneous expression pattern of interleukin
17A (IL-17A), IL-17F and their receptors in synovium of rheumatoid
arthritis, psoriatic arthritis and osteoarthritis: possible
explanation for nonresponse to anti-IL-17 therapy?. Arthritis Res
Ther. 2014; 16(4): 1-10.
3. Glatt S., et al. Bimekizumab, a Monoclonal Antibody that Inhibits
Both IL-17A and IL-17F, Produces a Profound Response in Both Skin
and Joints: Results of an Early-Phase, Proof-of-Concept Study in
Psoriatic Arthritis. Presented at the European League Against
Rheumatism (EULAR) 2015 Congress. Abstract # OP0108.
4. Gladman D.D., Antoni C., Mease P. et al. Psoriatic arthritis:
epidemiology, clinical features, course, and outcome. Ann Rheum
Dis. 2005; 64 Suppl 2: ii14-7.
5. Kavanaugh A., Fransen, A., Defining remission in psoriatic
arthritis. Clin Exp Rheumatol 2006; 24 (suppl. 43): S83-S87.
# # #
France Nivelle, Global Communications, UCB
T +32-2-559-9178, email@example.com
Laurent Schots, Media Relations, UCB
T +32-2-559-92-64, Laurent.firstname.lastname@example.org
Antje Witte, Investor Relations, UCB
T +32-2-559-94-14, email@example.com
Andrea Levin Christopher,
Immunology Communications, UCB
UCB, Brussels, Belgium (http://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 7 700 people in approximately 40
countries, the company generated revenue of EUR 3.9 billion in 2015.
UCB is listed on Euronext Brussels (symbol: UCB). Follow us on
Forward looking statements - UCB
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.