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 /CNW/ -- 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 EU/EEA
In the EU, CIMZIA^® in combination with methotrexate (MTX) is indicated for the treatment of moderate to severe active RA in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs (DMARDs) including MTX. 

CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate. CIMZIA in combination with MTX is also indicated for the treatment of severe, active and progressive RA in adults not previously treated with MTX or other DMARDs.

CIMZIA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with MTX.

CIMZIA, in combination with MTX, is also indicated for the treatment of active psoriatic arthritis in adults when the response to previous DMARD therapy has been inadequate. CIMZIA can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.

CIMZIA is also indicated in the EU for the treatment of adult patients with severe active axial spondyloarthritis (axSpA), comprising: 

• Ankylosing spondylitis (AS) – adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
• Axial spondyloarthritis (axSpA) without radiographic evidence of AS – adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated C-reactive protein (CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate response to, or are intolerant to NSAIDs.

CIMZIA is also indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 

About CIMZIA^® in Fertility, Pregnancy and Lactation in the EU/EEA

Women of childbearing potential
The use of adequate contraception should be considered for women of childbearing potential. For women planning pregnancy, continued contraception may be considered for 5 months after the last CIMZIA dose due to its elimination rate, but the need for treatment of the woman should also be taken into account (see below).

Pregnancy
Data from more than 500 prospectively collected pregnancies exposed to CIMZIA with known pregnancy outcomes, including more than 400 pregnancies exposed during the first trimester, does not indicate a malformative effect of CIMZIA. However, the available clinical experience is too limited to, with a reasonable certainty, conclude that there is no increased risk associated with CIMZIA administration during pregnancy.

Animal studies using a rodent anti-rat TNFα did not reveal evidence of impaired fertility or harm to the foetus. However, these are insufficient with respect to human reproductive toxicity. Due to its inhibition of TNFα, CIMZIA administered during pregnancy could affect normal immune response in the newborn.

CIMZIA should only be used during pregnancy if clinically needed. Non-clinical studies suggest low or negligible level of placental transfer of a homologue Fab-fragment of certolizumab pegol (no Fc region).

In a clinical study 16 women were treated with certolizumab pegol (200 mg every 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol plasma concentrations measured in 14 infants at birth were Below the Limit of Quantification (BLQ) in 13 samples; one was 0.042 µg/ml with an infant/mother plasma ratio at birth of 0.09%. At Week 4 and Week 8, all infant concentrations were BLQ. The clinical significance of low levels certolizumab pegol for infants is unknown. It is recommended to wait a minimum of 5 months following the mother's last CIMZIA administration during pregnancy before administration of live or live-attenuated vaccines (e.g. BCG vaccine), unless the benefit of the vaccination clearly outweighs the theoretical risk of administration of live or live-attenuated vaccines to the infants.

Breastfeeding
In a clinical study in 17 lactating women treated with CIMZIA, minimal transfer of certolizumab pegol from plasma to breast milk was observed. The percentage of the maternal certolizumab pegol dose reaching an infant during a 24 hour period was estimated to 0.04% to 0.30%. In addition, since certolizumab pegol is a protein that is degraded in the gastrointestinal tract after oral administration, the absolute bioavailability is expected to be very low in a breastfed infant. Consequently, CIMZIA can be used during breastfeeding.

Important Safety Information about CIMZIA^® in the EU/EEA 
Cimzia^® was studied in 4,049 patients with rheumatoid arthritis (RA) in controlled and open label trials for up to 92 months. The commonly reported adverse reactions (1-10%) in clinical trials with Cimzia^® and post-marketing were viral infections (includes herpeszoster, papillomavirus, influenza), bacterial infections (including abscess), rash, headache (including migraine), asthaenia, leukopaenia (including lymphopaenia, neutropaenia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme increase), injection site reactions, and nausea. Serious adverse reactions include sepsis, opportunistic infections, tuberculosis (including miliary, disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (includes heart failure), ischemic coronary artery disorders, pancytopaenia, hypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrovascular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4% of patients discontinued taking Cimzia® due to adverse events vs. 2.7% for placebo. 

Cimzia^® is contraindicated in patients with hypersensitivity to the active substance or any of the excipients, active tuberculosis or other severe infections such as sepsis or opportunistic infections and moderate to severe heart failure. 

Serious infections including sepsis, tuberculosis and opportunistic infections (e.g. histoplasmosis, nocardia, candidiasis) have been reported in patients receiving Cimzia^®. Some of these events have been fatal. Monitor patients closely for signs and symptoms of infections including tuberculosis before, during and after treatment with Cimzia^®. Treatment with Cimzia must not be initiated in patients with a clinically important active infection. If an infection develops, monitor carefully and stop Cimzia^® until the infection is controlled. Before initiation of therapy with Cimzia^®, all patients must be evaluated for both active and inactive (latent) tuberculosis infection. If active tuberculosis is diagnosed prior to or during treatment, Cimzia^® therapy must not be initiated and must be discontinued. If latent tuberculosis is diagnosed, appropriate anti-tuberculosis therapy must be started before initiating treatment with Cimzia®. Patients should be instructed to seek medical advice if signs/symptoms (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) suggestive of tuberculosis occur during or after therapy with Cimzia^®. 

Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Cimzia^® who are chronic carriers of the virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with Cimzia^®. Carriers of HBV who require treatment with Cimzia^® should be closely monitored and in the case of HBV reactivation Cimzia^® should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 

TNF antagonists including Cimzia^® may increase the risk of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, including multiple sclerosis; of formation of autoantibodies and uncommonly of the development of a lupus-like syndrome; of severe hypersensitivity reactions. If a patient develops any of these adverse reactions, Cimzia^® should be discontinued and appropriate therapy instituted. 

With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF antagonist cannot be excluded. Rare cases of neurological disorders, including seizure disorder, neuritis and peripheral neuropathy, have been reported in patients treated with Cimzia®. 

Adverse reactions of the haematologic system, including medically significant cytopaenia, have been reported with Cimzia®. Advise all patients to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising, bleeding, pallor) while on Cimzia^®. Consider discontinuation of Cimzia^® therapy in patients with confirmed significant haematological abnormalities. 

The use of Cimzia^® in combination with anakinra or abatacept is not recommended due to a potential increased risk of serious infections. As no data are available, Cimzia^® should not be administered concurrently with live vaccines. The 14-day half-life of Cimzia® should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on Cimzia^® should be closely monitored for infections. 

Cimzia^® was studied in 325 patients with active axial spondyloarthritis (axSpA) and in 409 patients with psoriatic arthritis (PsA) for up to 4 years. The safety profile for axSpA and PsA patients treated with Cimzia^® was consistent with the safety profile in RA and previous experience with Cimzia^® . 

Cimzia^® was studied in 1112 patients with psoriasis in controlled and open-label studies for up to 18 months. The safety profile of Cimzia^® 400 mg every 2 weeks and Cimzia^® 200 mg every 2 weeks were generally similar. 

Please consult the full prescribing information in relation to other side effects, full safety and prescribing information. European SmPC date of revision July 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/cimzia-0#product-information-section

CIMZIA^® is a registered trademark of the UCB Group of Companies.

For further information, UCB:

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 € 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.

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