Bimekizumab Phase 3 Data in Hidradenitis Suppurativa Show Clinically Meaningful, Deep and Maintained Response over 48 Weeks

Rhea-AI Summary

UCB reported promising results from two Phase 3 studies (BE HEARD I and II) on bimekizumab, an IL-17A and IL-17F inhibitor, for treating moderate to severe hidradenitis suppurativa (HS). At week 16, patients receiving bimekizumab experienced statistically significant improvements in HS symptoms compared to placebo, with HiSCR50 responses at 47.8% and 52.0% in BE HEARD I and II, respectively. The efficacy persisted to week 48, with over 75% of patients achieving HiSCR50. UCB plans to submit global regulatory applications for bimekizumab in HS in Q3 2023. No new safety signals were noted, with common adverse events including hidradenitis and oral candidiasis.

Positive

• Statistically significant improvement in HS symptoms at week 16 vs. placebo (HiSCR50: 47.8% and 52.0%) in BE HEARD I & II.
• Sustained clinical responses with over 75% of patients achieving HiSCR50 and over 55% achieving HiSCR75 at week 48.
• Plans for global regulatory submissions for bimekizumab in HS starting Q3 2023.

Negative

• Bimekizumab is not yet approved in the U.S. and its efficacy and safety for any indication have not been established.

• Patients treated with investigational bimekizumab, an IL-17A and IL-17F inhibitor, achieved statistically significant and clinically meaningful improvements over placebo in signs and symptoms of hidradenitis suppurativa at week 16, as measured by HiSCR50
• Bimekizumab demonstrated deep levels of clinical response over placebo at week 16, as measured by HiSCR75, a key secondary endpoint
• Patients treated with bimekizumab experienced improved health-related quality of life over placebo at week 16, a key secondary endpoint
• Clinical responses were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75, at week 48±

BRUSSELS and ATLANTA, March 18, 2023 /PRNewswire/ -- UCB, a global biopharmaceutical company, today announced detailed positive results from two Phase 3 studies (BE HEARD I and BE HEARD II) evaluating the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe hidradenitis suppurativa (HS).1 Data from the two studies showed that bimekizumab achieved statistically significant and consistent clinically meaningful improvements over placebo in the signs and symptoms of HS at week 16, which were maintained to week 48.1,± Clinical responses with bimekizumab were observed from the first dose with some patients achieving HiSCR50 at week four.1 These new data were presented today at a late-breaking platform presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, March 17-22.

"Hidradenitis suppurativa is a chronic, debilitating inflammatory skin disease for which only one approved treatment is available today," said Lead Investigator, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston. "Treating moderate to severe cases with bimekizumab has shown promising results in Phase 3 patient trials, with sustained improvement after one year."

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.

The two studies (n=505 in BE HEARD I; n=509 in BE HEARD II) evaluated two dose regimens of bimekizumab (320 mg every two weeks [Q2W] and 320 mg every four weeks

[Q4W]) versus placebo over the 16-week initial and the 32-week maintenance treatment periods.1 Data presented at AAD 2023 show that:

• A significantly higher proportion of patients treated with bimekizumab (Q2W) achieved HiSCR50, the primary endpoint, at week 16 vs. placebo in BE HEARD I and BE HEARD II (47.8 percent vs. 28.7 percent [p=0.006] and 52.0 percent vs. 32.2 percent [p=0.003], respectively).1
• A greater proportion of patients treated with bimekizumab (Q4W) achieved HiSCR50 at week 16 than placebo in BE HEARD I and BE HEARD II, with statistical significance achieved in BE HEARD II (45.3 percent vs. 28.7 percent [p=0.030] and 53.8 percent vs. 32.2 percent [p=0.004], respectively).1
• Patients treated with bimekizumab achieved deep levels of clinical response with a greater proportion achieving HiSCR75, a key secondary endpoint, at week 16 than placebo, with statistical significance in BE HEARD II with both dose regimens and for Q2W in BE HEARD I.1
• Patients treated with bimekizumab experienced improved health-related quality of life (change from baseline in the dermatology life quality index) compared with placebo at week 16 (BE HEARD I and BE HEARD II, Q2W and Q4W).1
• Clinical responses (HiSCR50 and HiSCR75) were maintained with continuous bimekizumab treatment – over 75 percent of patients achieved HiSCR50, and over 55 percent achieved HiSCR75 at week 48 (observed case analysis; BE HEARD I and BE HEARD II, Q2W and Q4W).1

"Today, at the largest dermatology meeting of the year, we unveiled 48-week data from our Phase 3 bimekizumab program in hidradenitis suppurativa. Results from the Phase 3 program highlight the meaningful clinical outcomes achieved by targeting IL-17F in addition to IL-17A," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "We are now focused on the next steps with global regulatory filings for bimekizumab in hidradenitis suppurativa planned for later this year."

The safety profile of bimekizumab across BE HEARD I and BE HEARD II was consistent with previous studies with no new safety signals observed.1 The most common (frequency of >5 percent) treatment emergent adverse events on bimekizumab over 16 weeks were hidradenitis (7.2 percent in BE HEARD I and 8.8 percent in BE HEARD II), oral candidiasis (4.4 percent in BE HEARD I and 6.7 percent in BE HEARD II), headache (7.0 percent in BE

HEARD I and 5.8 in BE HEARD II), and diarrhea (7.0 percent in BE HEARD I and 5.3 percent in BE HEARD II).1

UCB expects to submit global regulatory applications for bimekizumab in moderate to severe HS starting in Q3 2023.

Notes to editors:
± Observed case analysis.

About BE HEARD I and BE HEARD II

BE HEARD I is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe hidradenitis suppurativa (HS). BE HEARD I enrolled 505 participants with a diagnosis of moderate to severe HS. ¹

BE HEARD II is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in adults with moderate to severe HS. BE HEARD II enrolled 509 participants with a diagnosis of moderate to severe HS.¹

BE HEARD I and II comprised double-blind 16-week initial and 32-week maintenance treatment periods. Participants with moderate to severe HS were randomized 2:2:2:1 to (initial/maintenance) bimekizumab 320mg every 2 weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W, placebo/bimekizumab Q2W. Until week 16, bimekizumab Q2W/Q2W and bimekizumab Q2W/Q4W were combined to bimekizumab Q2W.¹

The primary endpoint in both studies was HiSCR50 at week 16.¹ A key secondary endpoint was HiSCR75 at week 16.¹ 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.^2,3

For additional details on the studies, visit BE HEARD I and BE HEARD II on clinicaltrials.gov.^2,3

About Hidradenitis Suppurativa

Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilitating inflammatory skin disease.^4,5 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.^4,5 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.^4,5

HS develops in early adulthood and affects approximately one percent of the population in most studied countries.^4,5 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.⁶

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.⁷ 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. ^4,6

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.⁸ In August 2021, bimekizumab was first approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.^9,10 The label information may differ in other countries where approved. Please check local prescribing information. 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 (FDA).

For further information, contact UCB:

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

U.S. Communications, Immunology
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 8,600 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.

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References

1. Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with moderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety from BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlled, multicenter studies. Late- Breaking Platform Presentation at the 2023 American Academy of Dermatology Annual Meeting.
2. 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: March 2023
3. 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: March 2023
4. Jemec GBE. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012;366(2):158-164.
5. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6:18.
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. Koumaki D, Ourania E, Bozi E, et al. Perspectives On Perceived Stigma And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Investig Dermatol. 2019;12:785–790.
8. 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.
9. BIMZELX® (bimekizumab) EU Summary of Product Characteristics, December 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last Accessed: March 2023.
10. BIMZELX® (bimekizumab) GB Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last accessed: March 2023.

 

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SOURCE UCB

FAQ

What were the results of the Phase 3 studies for bimekizumab in hidradenitis suppurativa?

The Phase 3 studies showed statistically significant improvements in HS symptoms, with HiSCR50 responses of 47.8% and 52.0% in BE HEARD I and II at week 16.

What is the timeline for bimekizumab's regulatory approval for hidradenitis suppurativa?

UCB plans to submit global regulatory applications for bimekizumab in hidradenitis suppurativa in the third quarter of 2023.

What is the safety profile of bimekizumab based on the Phase 3 trials?

The safety profile of bimekizumab was consistent with previous studies, and no new safety signals were observed.

How effective is bimekizumab after 48 weeks of treatment?

After 48 weeks, over 75% of patients maintained their response, achieving HiSCR50, and over 55% achieved HiSCR75.