New Data Affirms Strength of UCB Immuno-Dermatology Portfolio
-- Late breaking presentation of the Phase 2b long-term findings on the
investigational molecule, bimekizumab, demonstrates complete or almost
complete skin clearance in moderate-to-severe plaque psoriasis
-- Long-term data from Phase 3 studies CIMPASI-1, CIMPASI-2 and CIMPACT
highlight the strong efficacy and durability of CIMZIA(®) (certolizumab
pegol) in psoriasis
BRUSSELS, March 1, 2019 /PRNewswire/ -- UCB, a global biopharmaceutical company, will present results from the clinical development program of the company's key pipeline molecule, bimekizumab, a novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, in addition to new two-year data on CIMZIA® (certolizumab pegol) in patients with moderate-to-severe plaque psoriasis. These new data, presented at the American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C. (March 1-5, 2019), underscore the ongoing advancements of the company's immuno-dermatology portfolio and pipeline.
Notable data to be shared at AAD 2019 include a late-breaking oral presentation on a Phase 2b extension study of bimekizumab in patients with moderate-to-severe plaque psoriasis. The 60-week findings are the longest-term data so far, highlighting the clinical benefit of the molecule's unique mechanism of action, which includes dual neutralization of both IL-17A and IL-17F cytokines. UCB is also presenting 12-week results of the Phase 2 BE AGILE study of bimekizumab in ankylosing spondylitis and 48-week results of the BE ACTIVE study of bimekizumab in psoriatic arthritis. The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide. Ongoing Phase 3 studies will further define the safety and efficacy of bimekizumab.
"UCB research presented at AAD this year underscores our ongoing focus on delivering meaningful, differentiated outcomes for specific patient populations where there is significant unmet need. Psoriasis patients need durable, lasting skin clearance. The breadth of our immuno-dermatology development program can provide viable solutions for these patients. We are pleased to present long-term data demonstrating durable efficacy for Cimzia and robust Phase 2b data for bimekizumab. We are excited about further advances to come," said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.
Additional presentations include two-year findings from the CIMPASI-1 and CIMPASI-2 Phase 3 trials of CIMZIA(®) (certolizumab pegol), the only Fc-free, PEGylated anti-TNF, in psoriasis, investigating long-term treatment durability for this patient population with high unmet need. Furthermore, the company will present on the unmet clinical needs of women of childbearing age living with psoriasis and psoriatic arthritis.
Following is a guide to the UCB-sponsored data presentations:
Presentations on CIMZIA
Certolizumab Pegol for Plaque Psoriasis: 2-year Efficacy Results from Two Phase 3 Trials (CIMPASI-1 and CIMPASI-2), K. Gordon, K. Reich, A. Blauvelt, D. Thaçi, C. Leonardi, Y. Poulin, M. Boehnlein, S. Kavanagh, C. Arendt, A. B. Gottlieb
-- Session Information: ePoster only
Durability of Response in Plaque Psoriasis Patients Treated with Certolizumab Pegol: Two Year Data from the CIMPASI-1 and CIMPASI-2 Phase 3 Trials, K. Gordon, K. Reich, A. Blauvelt, D. Thaçi, C. Leonardi, Y. Poulin, M. Boehnlein, S. Kavanagh, C. Arendt, A. B. Gottlieb
-- Session Information: ePoster only
Efficacy of Certolizumab Pegol Dose Escalation in Patients Who Inadequately Respond to Initial Treatment: Results from the CIMPACT Trial, M. Augustin, M. Lebwohl, V. Piguet, H. Sofen, A. Blauvelt, L. Peterson, C. Arendt, M. Boehnlein, R. B. Warren
-- Session Information: ePoster oral presentation
-- Date/Time: Sunday, March 3, 10:20AM - 10:25AM
-- LOCATION: Hall H, ePoster Presentation Center 2
Presentations on UCB's Investigational Pipeline:
Bimekizumab
Dual Neutralization of Interleukin (IL)?17A and IL?17F with Bimekizumab in Moderate-to-Severe Plaque Psoriasis: 60-Week Results from a Randomized, Double-Blinded, Phase 2b Extension Study, A. Blauvelt, K. Papp, J. Merola, A. Gottlieb, N. Cross, C. Madden, M. Wang, C. Cioffi, C. Griffiths
-- Session Information: Late-breaking research presentation
-- Date/Time: Saturday, March 2, 2:40PM - 2:50PM
-- LOCATION: Ballroom A
Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active PsA: Overall and TNF-Inhibitor-Naïve Population Results from a 48-Week Phase 2b Randomized Study, J. Merola, A. Kavanaugh, G. Schett, J. Scher, R. Warren, D. Assudani, T. Kumke, B. Ink, I. McInnes, C. Ritchlin
-- Session Information: ePoster oral presentation
-- Date/Time: Friday, March 1, 12:45PM - 12:50PM
-- LOCATION: ePoster Presentation Center 1
Dual Neutralization of IL-17A and IL-17F with Bimekizumab in Patients with Active Ankylosing Spondylitis (AS): 12-Week Results from a Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study, D. van der Heijde, L. S. Gensler, A. Deodhar, X. Baraliakos, D. Poddubnyy, MK. Farmer, D. Baeten, T. Kumke, M. Oortgiesen, M. Dougados
-- Session Information: ePoster only
Women of Childbearing Age Research
Incidence of Peri-Pregnancy Flares Among Psoriasis Patients, B. Brady, G. Kim, R. Fowler, E. Lee, R. Suruki, J. Stark, L. Pisenti, M. Yassine, J. J. Wu
-- Session Information: ePoster oral presentation
-- Date/Time: Saturday, March 2, 12:30PM - 12:35 PM
-- LOCATION: Hall H, ePoster Presentation Center 2
Fears and Misconceptions of Women with Chronic Inflammatory Diseases on Their Journey to Motherhood, J. Murase, C. De Simone, R. Fischer-Betz, C. Ecoffet, A. Tincani
-- Session Information: ePoster oral presentation
-- Date/Time: Friday, March 1st, 10:05 AM - 10:10 AM
-- LOCATION: Hall H, ePoster Presentation Center 1
About Bimekizumab
Bimekizumab is an investigational novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have similar pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues.
Previous early phase clinical studies in psoriasis and psoriatic arthritis have suggested that bimekizumab's unique dual neutralization of both IL-17A and IL-17F may provide a new targeted approach for the treatment of immune-mediated inflammatory diseases.(i,ii,iii) Preclinical results in disease-relevant cells have shown that neutralizing IL-17F in addition to IL-17A reduces skin and joint inflammation, as well as pathological bone formation to an extent greater than inhibition of IL-17A alone.(ii,iv,v)
The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide.
About CIMZIA(® )in the US
CIMZIA(®) is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Factor). CIMZIA(®) has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha.
CIMZIA(®) is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). CIMZIA is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In addition, it is indicated to lessen the signs and symptoms of moderately to severely active Crohn's disease (CD) in adults who have not been helped enough by usual treatments.
Important Safety Information about CIMZIA(®) in the US
CONTRAINDICATIONS
CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria.
SERIOUS INFECTIONS
Patients treated with CIMZIA are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue CIMZIA if a patient develops a serious infection or sepsis.
Reported infections include:
-- Active tuberculosis (TB), including reactivation of latent TB. Patients
with TB have frequently presented with disseminated or extrapulmonary
disease. Test patients for latent TB before CIMZIA use and during
therapy. Initiate treatment for latent TB prior to CIMZIA use.
-- Invasive fungal infections, including histoplasmosis,
coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and
pneumocystosis. Patients with histoplasmosis or other invasive fungal
infections may present with disseminated, rather than localized,
disease. Antigen and antibody testing for histoplasmosis may be negative
in some patients with active infection. Consider empiric anti-fungal
therapy in patients at risk for invasive fungal infections who develop
severe systemic illness.
-- Bacterial, viral, and other infections due to opportunistic pathogens,
including Legionella and Listeria.
Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
-- Do not start CIMZIA during an active infection, including localized
infections.
-- Patients older than 65 years, patients with co-morbid conditions, and/or
patients taking concomitant immunosuppressants may be at greater risk of
infection.
-- If an infection develops, monitor carefully and initiate appropriate
therapy.
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.
-- Consider the risks and benefits of CIMZIA treatment prior to initiating
or continuing therapy in a patient with known malignancy.
-- In clinical trials, more cases of malignancies were observed among
CIMZIA-treated patients compared to control patients.
-- In CIMZIA clinical trials, there was an approximately 2-fold higher rate
of lymphoma than expected in the general U.S. population. Patients with
rheumatoid arthritis, particularly those with highly active disease, are
at a higher risk of lymphoma than the general population.
-- Malignancies, some fatal, have been reported among children,
adolescents, and young adults being treated with TNF blockers.
Approximately half of the cases were lymphoma, while the rest were other
types of malignancies, including rare types associated with
immunosuppression and malignancies not usually seen in this patient
population.
-- Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare
type of T-cell lymphoma, have been reported in patients treated with TNF
blockers, including CIMZIA. These cases have had a very aggressive
disease course and have been fatal. The majority of reported TNF blocker
cases have occurred in patients with Crohn's disease or ulcerative
colitis, and the majority were in adolescent and young adult males.
Almost all of these patients had received treatment with azathioprine or
6-mercaptopurine concomitantly with a TNF blocker at or prior to
diagnosis. Carefully assess the risks and benefits of treating with
CIMZIA in these patient types.
-- Cases of acute and chronic leukemia were reported with TNF blocker use.
HEART FAILURE
-- Worsening and new onset congestive heart failure (CHF) has been reported
with TNF blockers. Exercise caution and monitor carefully.
HYPERSENSITIVITY
-- Angioedema, anaphylactoid reaction, dyspnea, hypotension, rash, serum
sickness, and urticaria have been reported following CIMZIA
administration. If a serious allergic reaction occurs, stop CIMZIA and
institute appropriate therapy. The needle shield inside the removable
cap of the CIMZIA prefilled syringe contains a plastic derivative of
natural rubber latex which may cause an allergic reaction in individuals
sensitive to latex.
HEPATITIS B VIRUS REACTIVATION
-- Use of TNF blockers, including CIMZIA, may increase the risk of
reactivation of hepatitis B virus (HBV) in patients who are chronic
carriers. Some cases have been fatal.
-- Test patients for HBV infection before initiating treatment with CIMZIA.
-- Exercise caution in patients who are carriers of HBV and monitor them
before and during CIMZIA treatment.
-- Discontinue CIMZIA and begin antiviral therapy in patients who develop
HBV reactivation. Exercise caution when resuming CIMZIA after HBV
treatment.
NEUROLOGIC REACTIONS
-- TNF blockers, including CIMZIA, have been associated with rare cases of
new onset or exacerbation of central nervous system and peripheral
demyelinating diseases, including multiple sclerosis, seizure disorder,
optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.
HEMATOLOGIC REACTIONS
-- Rare reports of pancytopenia, including aplastic anemia, have been
reported with TNF blockers. Medically significant cytopenia has been
infrequently reported with CIMZIA.
-- Consider stopping CIMZIA if significant hematologic abnormalities occur.
DRUG INTERACTIONS
-- Do not use CIMZIA in combination with other biological DMARDS.
AUTOIMMUNITY
-- Treatment with CIMZIA may result in the formation of autoantibodies and,
rarely, in development of a lupus-like syndrome. Discontinue treatment
if symptoms of a lupus-like syndrome develop.
IMMUNIZATIONS
-- Patients on CIMZIA should not receive live or live-attenuated vaccines.
ADVERSE REACTIONS
-- The most common adverse reactions in CIMZIA clinical trials (>=8%) were:
upper respiratory infections (18%), rash (9%), and urinary tract
infections (8%).
For full prescribing information, please visit www.ucb-usa.com.
CIMZIA(®) is a registered trademark of the UCB Group of Companies.
For further information, UCB:
Corporate Communications
Investor Relations
Brand Communications
France Nivelle,
Antje Witte,
Andrea Levin Christopher,
Global Communications, UCB Investor Relations, UCB
Immunology Communications, UCB
T +32.2.559.94.14,
T +1.404.483.7329
T +32.2.559.9178,
antje.witte@ucb.com
france.nivelle@ucb.com
andrea.christopher@ucb.com
Laurent Schots,
Media Relations, UCB
T+32.2.559.92.64,
laurent.schots@ucb.com
About UCB
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 in immunology or neurology. With more than 7,500 people in approximately 40 countries, the company generated revenue of EUR 4.5 billion in 2017. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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.
References:
(i) Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017 May;83(5):991-1001. doi: 10.1111/bcp.13185. Epub 2017 Jan 10.
(ii) Papp K, Merola J, Gottlieb A, Griffiths C, Cross N, Peterson L, Cioffi C, Blauvelt A. Dual neutralization of both interleukin 17A and interleukin 17F with bimekizumab in patients with psoriasis: Results from BE ABLE 1, a 12-week randomized, double-blinded, placebo-controlled phase 2b trial. J Am Acad Dermatol. 2018 Aug;79(2):277-286.e10. https://www.ncbi.nlm.nih.gov/pubmed/29609013
(iii) Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation by bimekizumab in psoriatic arthritis: evidence from preclinical experiments and a randomized placebo-controlled clinical trial that IL-17F contributes to human chronic tissue inflammation. Ann Rheum Dis. 2018; 77(4):523-32
(iv) Shah M, Maroof A, Al-Hosni R, Gikas P, Gozzard N, Shaw S, Roberts S. Bimekizumab Blocks T Cell-Mediated Osteogenic Differentiation of Periosteal Stem Cells: Coupling Pathological Bone Formation to IL-17A and IL-17F Signaling [ACR abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10).
(v) Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-17A and IL-17F provides evidence of IL-17F contribution to chronic inflammation in disease-relevant cells. Ann Rheum Dis. 201706;76 (suppl.2):213-213.
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SOURCE UCB, Inc.
