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 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:

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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