UCB's bimekizumab demonstrates positive results in early development in patients with psoriatic arthritis

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[1],[2]
- 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[3]

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).[3]

(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.[4],[5] 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.[1],[2]

"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.[3]

About Bimekizumab

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.

References

1. Johansen et al. Characterization of the interleukin-17 isoforms
and receptors in lesional psoriatic skin. Br J Dermatol.
2009;160: 319-324.
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.

# # #

ots Originaltext: UCB Pharma
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Contact:
, UCB:
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Laurent Schots, Media Relations, UCB
T +32-2-559-92-64, Laurent.schots@ucb.com
Investor Relations
Antje Witte, Investor Relations, UCB
T +32-2-559-94-14, antje.witte@ucb.com
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Andrea Levin Christopher,
Immunology Communications, UCB
T +1-404-483-7329
andrea.levin@ucb.com
About 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
Twitter: @UCB_news
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