Almirall SA · BME:ALM
Almirall SA — Technical Presentation (March 2022)
30 slides from Almirall SA's technical presentation, Mar 30, 2022
Slide 1: Lebrikizumab ADvocate 1 & 2 16 week data
Lebrikizumab ADvocate 1 & 2 16 week data 30th March 2022 1
Slide 2: Disclaimer
Disclaimer This document has been prepared by Almirall, S.A. (the Such forward-looking statements are based on current “Company”) exclusively for use during the presentation. expectations and projections about future events and are This document includes only summary information and subject to vario
Slide 3: Agenda
Agenda 1. Introduction Atopic dermatitis market Gianfranco Nazzi, CEO 2. Lebrikizumab & Atopic Dermatitis Biologics & the IL-13 pathway Lebrikizumab, the science ADvocate 1 & 2 study design Phase 3, week 16 data Karl Ziegelbauer, CSO 3. Closing Remarks Gianfranco Nazzi, CEO Lebrikizumab 16 week phas
Slide 4: Introduction
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Slide 5: Dermatology, an attractive medical and commercial space
Dermatology, an attractive medical and commercial space Atopic dermatitis market potential analog to Psoriasis market Multiple severe unmet needs, Atopic dermatitis (AD) is an underserved exciting new science, sustainable and growing market. high growth Atopic dermatitis worldwide net sales, $ B* AD
Slide 6: Developments in the AD market
Developments in the AD market Lebrikizumab to be the third biologic to market JAK Abrocitinib UK Sep 2021 (Pfizer) JAK JAK Olumiant* Upadacitinib EMA Oct 2020 (Lilly) EU Aug 2021 (Abbvie) AD Developments 2021 2022 2023 2024 IL-4/IL-13 IL-13 Expected European IL-13 Tralokinumab potential approval of
Slide 7: Compelling profile
Compelling profile Primary & all key secondary endpoints met in pivotal phase 3 studies Compelling Clinically meaningful efficacy profile: Fast onset of action Phase 3 improvements significant improvements with in itch and other important with Lebrikizumab study confirms >50% of people treated achie
Slide 8: Statistically significant improvements in skin clearance and itching versus placebo
Lebrikizumab: Statistically significant improvements in skin clearance and itching versus placebo Improvements in interference of itch on sleep and quality of life Lebrikizumab delivered Data reinforce our belief We believe 52-week results rapid improvements in skin that Lebrikizumab from ADvocate 1
Slide 9: Lebrikizumab & Atopic Dermatitis
Lebrikizumab & Atopic Dermatitis 9
Slide 10: AD is a chronic, inflammatory skin disease characterized by intractable pruritus
AD is a chronic, inflammatory skin disease characterized by intractable pruritus Atopic dermatitis is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.1 AD is a heterogeneous disease Like other chronic Moderate-
Slide 11: IL-13 is the key driver of TH2 inflammation in Atopic Dermatitis
IL-13 is the key driver of TH2 inflammation in Atopic Dermatitis 1 IL-13 has a dominant role in lesional skin of AD patients and correlates with AD severity1,2 2 IL-4 was nearly undetectable in lesional skin2,3 and its therapeutic relevance in AD is unclear4,5 IL-13 vs IL-4 expression in skin IL-13
Slide 12: Lebrikizumab binds to IL-13 with high affinity
Lebrikizumab binds to IL-13 with high affinity Lebrikizumb Mechanism of Action 1 Lebrikizumab prevents the signaling of IL-13 through the heterodimeric receptor (IL-4Ra/IL-13Ra1)1,2. Lebrikizumab/IL-13 complex can bind to the IL-13Ra2 Sources and impact 2 receptor, without interfering the endogenous
Slide 13: Lebrikizumab has a different mode of action than other approved biologics
Lebrikizumab has a different mode of action than other approved biologics for atopic dermatitis Dupilumab Lebrikizumab Tralokinumab Target Binds IL4Rα receptor subunit Binds IL13 cytokine Binds IL13 cytokine Specifically prevents formation of Prevents IL13 binding to IL13Rα1 and Prevents formation o
Slide 14: ADvocate 1 & 2 study design
ADvocate 1 & 2 study Designed to evaluate Lebrikizumab as monotherapy in adult & adolescent patients with moderate-to-severe atopic dermatitis LDe LEB 250 mg Q2W Co-Primary endpoints: LDa Week 16 R 2:2:1 ▪ IGA 0/1 + ≥2 points of improvement LEB 250 mg Q4W LEB 250 mg respondersc from baseline at week
Slide 15: Primary Endpoint EASI-75
Primary Endpoint EASI-75 >50% of the patients achieved at least 75% improvement in overall disease severity ADvocate1 100 ADvocate1 Difference (ITT, MCMC-MI) (ITT, MCMC-MI) = 42.3% 80 Week 16 Patients (%) 60 59.3 40 20 16.4 *** Placebo Lebri 0 Placebo 250 mg LEB Q2W (n=141) Q2W (n=283) 100 ADvocate2
Slide 16: Primary Endpoint IGA
Primary Endpoint IGA IGA patient response rate as early as week 4 ADvocate1 100 ADvocate1 Difference (ITT, MCMC-MI) (ITT, MCMC-MI) = 29.6% 80 Week 16 Patients (%) 60 43.0 40 20 12.8 *** Lebri Placebo 0 Placebo 250 mg LEB Q2W (n=141) Q2W (n=283) 100 ADvocate2 Difference ADvocate2 (mITT, MCMC-MI) 80 =
Slide 17: Key secondary efficacy endpoints: EASI-90
Key secondary efficacy endpoints EASI-90 response rate 100 Difference ADvocate1 ADvocate1 = 29.1% (ITT, MCMC-MI) 80 (ITT, MCMC-MI) Patients (%) Week 16 60 40 38.2 20 9.1 *** Lebri Placebo 0 Placebo 250 mg LEB Q2W (n=141) Q2W (n=283) ADvocate2 ADvocate2 100 (mITT, MCMC-MI) Difference (mITT, MCMC-MI)
Slide 18: Key secondary efficacy endpoints: Pruritus NRS
Key secondary efficacy endpoints Pruritus NRS ≥4-point improvementa from baseline 100 Difference ADvocate1 ADvocate1 = 33.6% (ITT, MCMC-MI) 80 (ITT, MCMC-MI) Patients (%) Week 16 60 46.3 40 *** 20 12.7 Placebo Lebri 0 Placebo 250 mg LEB Q2W (n=130) Q2W (n=263) ADvocate2 ADvocate2 100 (mITT, MCMC-MI)
Slide 19: Key secondary efficacy endpoints: Sleep loss NRS
Key secondary efficacy endpoints Sleep loss NRS ≥2-point improvementa from baseline 100 Difference ADvocate1 ADvocate1 = 33.6% (ITT, MCMC-MI) 80 (ITT, MCMC-MI) Week 16 60 38.7 40 Patients (%) 20 *** 5.1 Lebri 0 Placebo Placebo 250 mg LEB Q2W (n=91) Q2W (n=195) ADvocate2 ADvocate2 100 (mITT, MCMC-MI)
Slide 20: Key secondary efficacy endpoints: Quality of life DLQI
Key secondary efficacy endpoints Quality of life: DLQI ≥4-point improvementa from baseline Difference 100 = 41.7% ADvocate1 ADvocate1 (ITT, MCMC-MI) (ITT, MCMC-MI) 80 75.5 Week 16 60 *** 40 33.8 Patients (%) 20 Placebo Lebri 0 Placebo 250 mg LEB Q2W (n=116) Q2W (n=226) Difference ADvocate2 ADvocate2
Slide 21: Lebrikizumab was well tolerated
Lebrikizumab was well tolerated Overall incidence of adverse events comparable to placebo ADvocate1 (Safety Population) ADvocate2 (Modified Safety Populationc) LEB 250 mg LEB 250 mg Placebo Q2W Placebo Q2W Q2W Q2W (N=141) (N=145) (N=282) (N=281) Any TEAE 72 (51.5) 128 (45.4) 96 (66.2) 149 (53.0) Mil
Slide 22: Key Takeaways
Key Takeaways Lebrikizumab phase 3, week 16 data These data from two Lebrikizumab 250 mg pivotal phase 3 trials demonstrated rapid efficacy Most TEAEs were mild suggest that in primary and key The lebrikizumab phase 3 data or moderate in severity, lebrikizumab 250 mg secondary endpoints. reinforces
Slide 23: Closing Remarks
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Slide 24: AD an underserved and growing market
AD an underserved and growing market Almirall to leverage strong commercial footprint in Europe Number of atopic dermatitis patients treated with biologics is Mod-Severe expected to be at least comparable with psoriasis by 2026.* 5.5 MM 18 MM atopic dermatitis patients in EU by 2026 A meaningful sha
Slide 25: Conclusions
Conclusions Compelling profile Fast onset of action with Lebrikizumab rapidly improved skin and itch symptoms within 4 weeks. Lebrikizumab led to significant improvements On track for a 2023 potential with >50% of people treated approval in the EU, as we achieved at least 75% continue to work with o
Slide 26: Appendices
Appendices 26 Lebrikizumab 16 week phase 3 data
Slide 27: ADvocate 1 & 2 baseline demographics and characteristics
ADvocate 1 & 2 ADvocate1 (ITT) ADvocate2 (mITT) Placebo Q2W LEB 250 mg Q2W Placebo Q2W LEB 250 mg Q2W (N=141) (N=283) (N=146) (N=281) Age, years 34.2 (16.4) 36.1 (17.8) 35.3 (17.2) 36.6 (16.8) Baseline Adolescent (12 to <18 years old), n (%) 18 (12.8) 37 (13.1) 17 (11.6) 30 (10.7) demographics & Adu
Slide 28: ADvocate 1 & 2 baseline disease characteristics
ADvocate 1 & 2 ADvocate1 (ITT) ADvocate2 (mITT) Placebo Q2W LEB 250 mg Q2W Placebo Q2W LEB 250 mg Q2W (N=141) (N=283) (N=146) (N=281) Disease duration since AD 23.7 (15.4) 22.0 (14.8) 20.1 (14.4) 20.8 (15.2) Baseline disease diagnosis, years characteristics IGA, n (%) 3 (moderate) 83 (58.9) 170 (60.
Slide 29: ADvocate 1 & 2 use of rescue medication
ADvocate 1 & 2 ADvocate1 (ITT) ADvocate2 (mITT) LEB 250 mg LEB 250 mg Placebo Q2W Placebo Q2W Use of rescue Q2W Q2W (N=141) (N=146) (N=283) (N=281) medication Any rescue medicationa 47 (33.3) 30 (10.6) 58 (39.7) 56 (19.9) through week 16 Topical rescue medication 44 (31.2) 27 (9.5) 54 (37.0) 52 (18.
Slide 30: www.almirall.com
For further information, please contact: Pablo Divasson del Fraile Investor Relations & Corporate Comms. Tel. +34 93 291 3087 pablo.divasson@almirall.com Or visit our website: www.almirall.com Lebrikizumab 16 week phase 3 data 30