UCB Reinforces Commitment to Advancing Care in Hidradenitis Suppurativa with Six Abstracts at SHSA 2023

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UCB to present data on bimekizumab in hidradenitis suppurativa at symposium

Positive

• UCB will present data on bimekizumab in hidradenitis suppurativa at the 8th Annual Symposium on Hidradenitis Suppurativa Advances.
• Data from Phase 3 studies evaluating the impact of bimekizumab on pain and health-related quality of life will be shared.
• The presentations highlight the potential of bimekizumab for the treatment of this chronic, painful, inflammatory condition.

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• No concrete business takes affecting stock price are mentioned in the PR.

• Results from the Phase 3 studies evaluating impact of bimekizumab on pain and health-related quality of life in moderate-to-severe hidradenitis suppurativa will be shared in two oral presentations

ATLANTA, Oct. 13, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced that it will present six abstracts in hidradenitis suppurativa (HS) at the 8th Annual Symposium on Hidradenitis Suppurativa Advances (SHSA), October 13–15 in Phoenix, Arizona. Data and analyses in HS will be presented across two oral presentations and four posters.

"The data to be presented at SHSA reinforce our commitment to advancing medicines in areas where patients have the greatest need," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "These new analyses complement and build on the bimekizumab Phase 3 evidence in hidradenitis suppurativa shared to date and further highlight the potential of bimekizumab for the treatment of this chronic, painful, inflammatory condition."

An oral presentation will showcase 16-week data from the BE HEARD I and BE HEARD II Phase 3 studies evaluating the impact of bimekizumab on pain in moderate-to-severe HS. In a second oral presentation, 48-week data evaluating the impact of bimekizumab on health-related quality of life will be shared. Three poster presentations will include subgroup analyses from the two Phase 3 studies, including 48-week data in U.S. patients. A disease-focused poster presentation, developed by the HS Coalition, will share barriers to accessing timely and adequate treatment, care, and resources for HS patients in select U.S. states.

The HS Coalition, a leading group of patient advocates and healthcare professionals convened by UCB, is an independent, multi-stakeholder coalition aimed at addressing health inequities in HS with a focus on transforming the policy and access landscape in the U.S. The research showed that, depending on which state they live in, people living with HS in the U.S. face different challenges to accessing care, in part due to delay in diagnosis and restrictive insurance policies. These differences compound the existing health inequity in HS.

In the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration. 

UCB-sponsored data presentations at SHSA 2023

• Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: 48-Week HiSQoL data from BE HEARD I & II
  Kirby JS, Jemec GB, Thorlacius L, Garg A, Kimball AB, Rolleri R, Muller E, Lambert J, Ingram JR
  Oral presentation: Saturday, October 14, 16:05–16:15 MST
  
  
• Bimekizumab Impact on Pain in Moderate to Severe Hidradenitis Suppurativa: Week 16 Results from BE HEARD I & II
  Orenstein LAV, Shi V, Lev-Tov H, Prens E, Podda M, Fujita H, Lambert J, Rolleri R, Muller E, Szepietowski JC
  Oral presentation: Saturday, October 14, 16:35–16:45 MST
  
  
• Bimekizumab in Black/African-American Patients with Moderate to Severe Hidradenitis Suppurativa in BE HEARD I & II
  Mayo T, Chovatiya R, Shi V, Naik HB, Benhadou F, Costanzo A, Davis L, Lambert J, Rolleri R, Zouboulis CC Poster
  
  
• Bimekizumab in Patients with Moderate to Severe Hidradenitis Suppurativa by Subgroup: Week 16 Data from BE HEARD I & II
  Naik HB, Hsiao J, Porter M, Reguiai Z, Martorell A, Frew JW, Pansar I, Rolleri R, Tilt N, Lambert J, Kirby B Poster
  
  
• Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: 48-Week Efficacy in US Patients from BE HEARD I & II
  Gottlieb AB, Mayo T, Sayed C, Kirby JS, Garg A, Oh T, Gomez B, Dokhe P, Rolleri R, Davis L, Daveluy Poster
  
  
• Barriers to Accessing Timely and Adequate Treatment, Care, and Resources for Patients with HS in Select US States
  Daveluy S, Brooks B, Hazelett B, Hamzavi I, DiSalvo A, Schmidt T, Marchi D, McClung L, Beaty S, Espy JI, Goldberg S Poster

Notes to editors:
About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of bimekizumab in adults with moderate-to-severe hidradenitis suppurativa (HS).^1,2 The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS.^1,2 The primary endpoint in both studies was HiSCR50 at Week 16.^1,2 A key secondary endpoint was HiSCR75 at Week 16.^1,2 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.^1,2

About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.^3,4 The main symptoms are nodules, abscesses, and pus-discharging fistulas (channels leading out of the skin), which typically occur in the armpits, groin, and buttocks.^3,4 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^3,4

HS most commonly develops in early adulthood and affects approximately one percent of the population in most studied countries.^3,4 Approximately one-third of people with HS have a family history of HS, and lifestyle factors such as smoking and obesity can also play a crucial role in the clinical course of HS. ^3,4

The symptoms of pain, discharge, and scarring are not only a physical burden. People with HS also experience stigma: worrying about or directly experiencing negative attitudes and reactions from society in response to their symptoms.⁵ These feelings can lead to embarrassment, social isolation, low self-esteem, and sexual life impairment, and impact all areas of life, including interpersonal relationships, education, and work.⁶

About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.⁷ In the U.S., the efficacy and safety of bimekizumab have not been established for any indication and it is not approved by the U.S. Food and Drug Administration. 

For further information, contact UCB:

Investor Relations
Antje Witte
T: +32.2.559.94.14
email antje.witte@ucb.com 

U.S. Communications
Nicole Herga
T +1.773.960.5349
email nicole.herga@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 of the immune system or of the central nervous system. With approximately 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.

Forward looking statements 
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Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.

UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations.

Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.

References

1. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I). Available at: https://clinicaltrials.gov/ct2/show/NCT042424461. Last accessed: October 2023.
2. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II). Available at: https://clinicaltrials.gov/ct2/show/NCT04242498 Last accessed: October 2023.
3. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164.
4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6:18.
5. Koumaki D, Efthymiou O, Bozi E, et al. Perspectives on Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12:785–90.
6. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology. 2020;236:421–430.
7. 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;83(5):991-1001.

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SOURCE UCB

FAQ

What is the focus of the presentations at the symposium?

The presentations will focus on data from Phase 3 studies evaluating the impact of bimekizumab on pain and health-related quality of life in hidradenitis suppurativa.

What is bimekizumab?

Bimekizumab is a potential treatment for hidradenitis suppurativa being developed by UCB.

Is bimekizumab approved by the FDA?

No, bimekizumab is not approved by the U.S. Food and Drug Administration for any indication.

What is hidradenitis suppurativa?

Hidradenitis suppurativa is a chronic, painful, inflammatory condition.

Who is UCB?

UCB is a global biopharmaceutical company.