LLY Eli Lilly and Co

Monthly EGBLYSS maintenance dosing sustained clear or almost-clear skin for up to three years in the vast majority of ADvocate 1 and 2 responders

Nearly 87 percent of patients taking EBGLYSS did not require either high-potency topical corticosteroids or systemic treatments during the three-year study

The safety profile at three years was consistent with the previously published two-year results

INDIANAPOLIS, Sept. 25, 2024 /PRNewswire/ -- More than 80 percent of adults and adolescents with moderate-to-severe atopic dermatitis who responded to EBGLYSS™ treatment at Week 16 in the ADvocate 1 and 2 monotherapy trials and continued treatment for up to three years experienced sustained skin clearance with monthly maintenance dosing. Eli Lilly and Company (NYSE: LLY) announced these new long-term results from the ADjoin long-term extension study, which will be presented at the European Academy of Dermatology and Venereology (EADV) Congress from Sept. 25-28 in Amsterdam, Netherlands.¹ 

EBGLYSS is an interleukin-13 (IL-13) inhibitor that selectively blocks IL-13 signaling with high binding affinity.^2,3,4 The cytokine IL-13 is key in atopic dermatitis, driving the type-2 inflammatory cycle in the skin, leading to skin barrier dysfunction, itch, skin thickening and infection.^5,6 

"The chronic and persistent signs and symptoms of atopic dermatitis affect patients' daily lives, highlighting the need for a treatment that can provide sustained, long-term relief," said Eric Simpson, M.D., M.C.R., professor of dermatology and director of clinical research at Oregon Health & Science University School of Medicine in Portland, Oregon, and senior author and investigator of the ADjoin analysis. "These three-year results provide compelling evidence of durable efficacy and a consistent safety profile, offering further long-term evidence for health care providers seeking a new biologic treatment option for their patients."

Patients taking EBGLYSS who completed 52 weeks in ADvocate 1 or 2 could enroll in ADjoin for an additional 100 weeks of continued treatment (up to 152 weeks of continuous treatment). Patients in this analysis of the long-term extension trial received treatment either 250 mg every two weeks (Q2W) or once monthly (Q4W). The approved maintenance dose of EBGLYSS is 250 mg Q4W. These data presented are part of ADjoin, the long-term extension study of the EBGLYSS trials, and include participants who responded to EBGLYSS treatment at Week 16 from ADvocate 1 and ADvocate 2. ¹

• 84 percent of these patients taking EBGLYSS once monthly and 83 percent taking EBGLYSS every two weeks maintained clear or almost-clear skin (IGA 0,1) at three years.¹
• 87 percent of these patients taking EBGLYSS once monthly and 79 percent taking EBGLYSS every two weeks achieved or maintained at least 90 percent improvement in disease extent and severity (EASI-90) at three years.¹
• 83 percent of these patients taking EBGLYSS once monthly and 91 percent taking EBGLYSS every two weeks did not require either high-potency topical corticosteroids or systemic treatments.¹

The safety profile of these patients taking EBGLYSS in ADjoin was consistent with previous EBGLYSS studies, and no new safety signals were observed up to three years of treatment. The majority of adverse events were mild or moderate. Less than three percent of patients experienced adverse events leading to treatment discontinuation. The most common side effects of EBGLYSS were conjunctivitis, injection site reactions and shingles (herpes zoster).¹

"Without adequate treatment, atopic dermatitis can leave people struggling with uncontrolled symptoms," said Mark Genovese, M.D., senior vice president of Immunology Development at Lilly. "EBGLYSS selectively targets IL-13, one of the main drivers of inflammation in eczema. These three-year data demonstrate that EBGLYSS given once monthly provides durable symptom relief for patients who need it most."

Additional data from this clinical study is underway, with results to be presented at future congresses. 

EBGLYSS was approved in the U.S. by the Food and Drug Administration (FDA) earlier this month. EBGLYSS was also approved in the European Union in 2023, as well as in Japan in January 2024, with additional markets expected later this year.

"These latest clinical data for EBGLYSS show the potential of this innovative medicine to provide sustained improvement of moderate-to-severe atopic dermatitis, a chronic and often debilitating condition," said Volker Koscielny, M.D., Chief Medical Officer at Almirall. "The data can help inform clinical decision-making and are reassuring, as they show that the vast majority of patients who respond to the treatment will continue to respond over time."

Lilly has exclusive rights for development and commercialization of EBGLYSS in the U.S. and the rest of the world outside Europe. Lilly's partner Almirall has licensed the rights to develop and commercialize EBGLYSS for the treatment of dermatology indications, including eczema, in Europe.

About ADjoin
ADjoin (NCT04392154) evaluated the long-term safety and efficacy of EBGLYSS treatment in patients with moderate-to-severe atopic dermatitis for up to 100 weeks (up to 152 weeks of continuous treatment with the parent studies). Patients taking EBGLYSS who completed any of the parent studies (ADvocate 1 and 2, ADhere, ADore, ADopt-VA) were able to enroll in ADjoin. The ADhere parent study includes patients taking topical corticosteroids with EBGLYSS as a combination therapy. Patients could also enroll directly into ADjoin without participating in a parent study. Patients in this analysis of the long-term extension trial received either EBGLYSS 250 mg every two weeks or once monthly.¹

INDICATION AND SAFETY SUMMARY 
EBGLYSS™ (EHB-glihs) is an injectable medicine used to treat adults and children 12 years of age and older who weigh at least 88 pounds (40 kg) with moderate-to-severe eczema (atopic dermatitis) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. EBGLYSS can be used with or without topical corticosteroids.

It is not known if EBGLYSS is safe and effective in children less than 12 years of age or in children 12 years to less than 18 years of age who weigh less than 88 pounds (40 kg).

Warnings - Do not use EBGLYSS if you are allergic to lebrikizumab-lbkz or to any of the ingredients in EBGLYSS. See the Patient Information leaflet that comes with EBGLYSS for a complete list of ingredients.

Before using
Before using EBGLYSS, tell your healthcare provider about all your medical conditions, including if you:

• Have a parasitic (helminth) infection.
• Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with EBGLYSS.
• Are pregnant or plan to become pregnant. It is not known if EBGLYSS will harm your unborn baby. If you become pregnant during treatment with EBGLYSS, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.
• Are breastfeeding or plan to breastfeed. It is not known if EBGLYSS passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Possible side effects
EBGLYSS can cause serious side effects, including:

• Allergic reactions. EBGLYSS can cause allergic reactions that may sometimes be severe. Stop using EBGLYSS and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms:
  • breathing problems or wheezing
  • itching
  • swelling of the face, lips, mouth, tongue or throat
  • fainting, dizziness, feeling lightheaded
  • skin rash
  • hives
  • cramps in your stomach area (abdomen)
• Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision.

The most common side effects of EBGLYSS include:

• eye and eyelid inflammation, including redness, swelling, and itching
• injection site reactions
• shingles (herpes zoster)

These are not all of the possible side effects of EBGLYSS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How to take

• See the detailed "Instructions for Use" that comes with EBGLYSS for information about how to prepare and inject EBGLYSS and how to properly store and throw away (dispose of) used EBGLYSS prefilled pens and prefilled syringes.
• Use EBGLYSS exactly as prescribed by your healthcare provider.
• EBGLYSS is given as an injection under the skin (subcutaneous injection).
• If your healthcare provider decides that you or a caregiver can give the injections of EBGLYSS, you or a caregiver should receive training on the right way to prepare and inject EBGLYSS. Do not try to inject EBGLYSS until you have been shown the right way by your healthcare provider. In children 12 years of age and older, EBGLYSS should be given by a caregiver.
• If you miss a dose of EBGLYSS, inject the missed dose as soon as possible, then inject your next dose at your regular scheduled time.

Learn more
EBGLYSS is a prescription medicine available as a 250 mg/2 mL injection prefilled pen or prefilled syringe. For more information, call 1-800-545-5979 or go to ebglyss.lilly.com

This summary provides basic information about EBGLYSS but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about EBGLYSS and how to take it. Your doctor is the best person to help you decide if EBGLYSS is right for you.

LK CON BS AD APP

EBGLYSS™ and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

About EBGLYSS 
EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate.^3,4,7 EBGLYSS binds to the IL-13 cytokine at an area that overlaps with the binding site of the IL-4Rα subunit of the IL-13Rα1/IL-4Rα heterodimer, preventing formation of this receptor complex and inhibiting IL-13 signaling.⁵ IL-13 is implicated as a primary cytokine tied to the pathophysiology of eczema, driving the type-2 inflammatory loop in the skin, and EBGLYSS selectively targets IL-13.⁷

The EBGLYSS Phase 3 program consists of five key global studies evaluating over 1,300 patients, including two monotherapy studies (ADvocate 1 and 2), a combination study with topical corticosteroids (ADhere), as well as long-term extension (ADjoin) and adolescent open label (ADore) studies. Further data results from ADmirable and ADapt are expected to be shared in 2024 and early 2025.  

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY

Cautionary Statement Regarding Forward-Looking Statements  
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about EBGLYSS (lebrikizumab-lbkz) as a treatment for patients with moderate-to severe atopic dermatitis and the timeline for future readouts, presentations, and other milestones relating to EBGLYSS and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with the results to date or that EBGLYSS will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

¹ Thaci E, et al. Efficacy and Safety of Lebrikizumab is Maintained up to Three Years in Patients with Moderate-to-Severe Atopic Dermatitis: ADvocate 1, ADvocate 2, and ADjoin Long Term Extension Trial. 2024 European Academy of Dermatology and Venereology Congress. September 25, 2024.
² Simpson EL, et al. Efficacy and safety of lebrikizumab (an anti-IL-13 monoclonal antibody) in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical corticosteroids: A randomized, placebo-controlled phase II trial (TREBLE). J Am Acad Dermatol. 2018;78(5):863-871.e11. doi:10.1016/j.jaad.2018.01.017
³ Okragly A, et al. Binding, Neutralization and Internalization of the Interleukin-13 Antibody, Lebrikizumab. Dermatol Ther (Heidelb). 2023;13(7):1535-1547. doi:10.1007/s13555-023-00947-7
⁴ Ultsch M, et al. Structural basis of signaling blockade by anti-IL-13 antibody Lebrikizumab. J Mol Biol. 2013;425(8):1330-1339. doi:10.10116/j.jmb.2013.01.024
⁵ Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54–62. doi:10.1111/all.13954
⁶ Tsoi LC, et al. Atopic Dermatitis Is an IL-13-Dominant Disease with Greater Molecular Heterogeneity Compared to Psoriasis. J Invest Dermatol. 2019;139(7):1480-1489. doi:10.1016/j.jid.2018.12.018
⁷ EBGLYSS. Prescribing Information. Lilly USA, LLC.

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