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LEO Pharma Presents Phase 3 Data in Atopic Dermatitis and Plaque Psoriasis at the American Academy of Dermatology Virtual Meeting Experience 2020

June 2, 2020 Off By BusinessWire

— Data include pivotal efficacy and safety clinical trials of tralokinumab monotherapy and tralokinumab with concomitant topical corticosteroid use in adult patients with moderate-to-severe atopic dermatitis —

BALLERUP, Denmark & MADISON, N.J.–(BUSINESS WIRE)–LEO Pharma A/S, a global leader in medical dermatology, today announced it will present data – including Phase 3 clinical trials in atopic dermatitis (AD) and psoriasis – from its dermatology pipeline and portfolio at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2020, June 12-14, 2020.

Data include pivotal Phase 3 ECZTRA 1, ECZTRA 2 and ECZTRA 3 clinical trials evaluating tralokinumab monotherapy and tralokinumab with concomitant topical corticosteroid use in adult patients with moderate-to-severe AD. Tralokinumab is an investigational agent under clinical development, and its safety and efficacy have not been evaluated by any regulatory authority.

“Building on our legacy in topical treatments for psoriasis and skin infections, LEO Pharma looks to expand into new areas of dermatology and broaden our portfolio of treatment offerings with the aim to benefit even more patients,” said Kim Kjoeller, LEO Pharma Executive Vice President Global Research & Development. “These data presented at AAD VMX advance our R&D pipeline and support our transformative journey to become an innovation-driven growth company with treatments across dermatology, including in rare diseases.”

LEO Pharma will also present safety and efficacy results of Enstilar^® (calcipotriene and betamethasone dipropionate) Foam, for topical use, in adult patients with plaque psoriasis from the PSO-LONG clinical trial, a Phase 3, multicenter, randomized, 52-week, vehicle-controlled trial.

Data will be available online and on-demand beginning at 2 p.m. Central, Friday, June 12, through Dec. 31, 2020.

Late Breaking Research: Clinical Trials

Live events, including Q&A with the speakers, will take place Friday, June 12, through Sunday, June 14.

Title

Presenter

Efficacy and safety of tralokinumab monotherapy in adult patients with moderate-to-severe atopic dermatitis: Results from two 52-week Phase 3 trials (ECZTRA 1 and ECZTRA 2)

Eric Simpson, M.D., M.C.R., Oregon Health & Science University

Efficacy and safety of tralokinumab with concomitant topical corticosteroid in adult patients with moderate-to-severe atopic dermatitis: Results from the 32-week Phase 3 ECZTRA 3 trial

Jonathan Silverberg, M.D., PhD, MPH, The George Washington University School of Medicine and Health Sciences

ePosters

No.	Title	Authors
12797	Safety of long-term proactive management with fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam in patients with psoriasis vulgaris: Results of a phase III, multicenter, randomized, 52-week, vehicle-controlled trial	Mark Lebwohl, Jean-Philippe Lacour, Monika Liljedahl, Charles Lynde, Marie Holst Mørch, Anja Marieke Snel-Prentø, Diamant Thaci, Richard B Warren
16127	Efficacy of ingenol mebutate in patients with actinic keratosis on face and scalp: Subgroup analysis of a 12-month observational follow-up study according to age (<65 and ≥65 years)	Hee J. Kim, Nikeshia Dunkelly-Allen, Jes B. Hansen, Karen A. Veverka, Mark G. Lebwohl
16258	Evaluation of different approaches in managing local skin reactions with the use of ingenol mebutate 0.015% and 0.05% during the treatment of actinic keratosis	Scott Freeman, Miriam Bettencourt, Meg Corliss, Nikeshia Dunkelly-Allen, Karen A. Veverka
16419	Real-world studies for local skin reactions with the use of ingenol mebutate 0.015% and 0.05% to predict treatment efficacy	Gary Goldenberg, Miriam Bettencourt, Scott Freeman, Meg Corliss, Nikeshia Dunkelly-Allen, Karen A. Veverka
16809	Impact of atopic dermatitis and chronic hand eczema on quality of life compared to other chronic diseases: A structured review	Silvia Capucci, Julie Hahn-Pedersen, Andreas Vilsboell, Nana Kragh
16830	Results from the open-label treatment period of a long-term proactive management phase III trial using fixed-dose combination calcipotriene 0.005% and betamethasone dipropionate 0.064% foam	Mark Lebwohl, Jean-Philippe Lacour, Monika Liljedahl, Charles Lynde, Marie Holst Moerch, Anja Marieke Snel-Prentoe, Diamant Thaçi, Richard B. Warren
17754	Treatment success in mild psoriasis patients with fixed-combination calcipotriene and betamethasone dipropionate (Cal/BD) foam: Results from the PSO-FAST trial	Karen A. Veverka, Jes B. Hansen, Maria Yaloumis, Leon Kircik, Linda Stein Gold
18223	Long-term proactive management of psoriasis vulgaris with fixed-dose combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% foam: Results of a Phase III randomized controlled trial	Mark Lebwohl, Jean-Philippe Lacour, Monika Liljedahl, Charles Lynde, Marie Holst Moerch, Anja Marieke Snel-Prentoe, Diamant Thaçi, Richard B. Warren

For more information about AAD VMX 2020, visit AAD VIRTUAL MEETING EXPERIENCE (VMX). For more information about LEO Pharma, visit www.leo-pharma.com.

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About tralokinumab

Tralokinumab is a fully human monoclonal antibody that specifically neutralizes the IL-13 cytokine,^1,2 a key driver of the underlying chronic inflammation in atopic dermatitis (AD). By specifically binding to the IL-13 cytokine with high affinity, tralokinumab prevents its interaction with the receptor and the subsequent downstream IL-13 signalling.1^,2

U.S. FDA APPROVED INDICATION FOR ENSTILAR^® (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE) FOAM

Enstilar^® (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older. Apply Enstilar Foam to affected areas once daily for up to 4 weeks. Discontinue use when control is achieved. Instruct patients not to use more than 60 grams every 4 days.

IMPORTANT SAFETY INFORMATION

For topical use only. Enstilar Foam is not for oral, ophthalmic or intravaginal use and should not be applied on the face, groin or axillae or if skin atrophy is present at the treatment site. Do not use with occlusive dressings. Patients should wash hands after application.

WARNINGS AND PRECAUTIONS

Flammability: The propellants in Enstilar Foam are flammable. Instruct patients to avoid fire, flame, and smoking during and immediately following application.
Hypercalcemia and Hypercalciuria: Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize.
Effects on Endocrine System: Can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factors include the use of high-potency topical corticosteroid, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and young age. Modify use should HPA axis suppression develop.

Cushing’s syndrome, hyperglycemia and glucosuria may occur due to the systemic effects of the topical corticosteroid.

Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios.

Allergic Contact Dermatitis: Allergic contact dermatitis has been observed with topical calcipotriene and topical corticosteroids.
Ophthalmic Adverse Reactions: May increase the risk of posterior subcapsular cataracts and glaucoma. Avoid contact of Enstilar Foam with eyes. Enstilar

Foam may cause eye irritation. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

ADVERSE REACTIONS

Adverse reactions reported in <1% of adult subjects included: application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.
Adverse reactions reported in <1% of pediatric subjects (12-17 years of age) were acne, erythema, application site pain, and skin reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: Advise pregnant women that Enstilar Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible.

Lactation: No data are available regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk. Use Enstilar Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Enstilar Foam directly to the nipple and areola to avoid direct infant exposure.

Pediatric Use: The safety and effectiveness of Enstilar Foam in pediatric patients less than 12 years of age have not been established. Pediatric patients may be more susceptible to systemic toxicity, HPA axis suppression, and adrenal insufficiency due to their larger skin surface to body mass ratios.

You are encouraged to report side effects of prescription drugs to the FDA. Visit MedWatch: The FDA Safety Information and Adverse Event Reporting Program or call 1-800-FDA-1088.

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email [email protected].

For more information, please see U.S. FDA Full Prescribing Information for Enstilar Foam.

U.S. FDA APPROVED INDICATION FOR PICATO^® (INGENOL MEBUTATE) GEL

Picato^® (ingenol mebutate) gel is indicated for the topical treatment of actinic keratosis. For treatment on the face or scalp, Picato gel 0.015% should be applied to the affected area once daily for 3 consecutive days. For treatment on the trunk or extremities, Picato gel 0.05% should be applied to the affected area once daily for 2 consecutive days.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

Picato gel is contraindicated in patients with known hypersensitivity to ingenol mebutate or any component of the formulation. Anaphylaxis, as well as allergic reactions leading to hospitalization have been reported in postmarketing use of Picato gel.

For topical use only. Picato gel is not for oral, ophthalmic or intravaginal use. Avoid transfer of Picato gel to periocular area or application near and around the mouth and lips. For application of up to one contiguous skin area of approximately 25 cm2 (5 cm x 5 cm) using one unit dose tube. Patients should wash hands well immediately after application.

WARNINGS AND PRECAUTIONS

Ophthalmic Adverse Reactions: Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis and allergic contact dermatitis, have been reported postmarketing. If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato gel immediately and institute appropriate medical therapy.
Local Skin Reactions: Severe skin reactions in the treated area, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration can occur after topical application of Picato gel. Administration of Picato gel is not recommended until the skin is healed from any previous drug or surgical treatment.

ADVERSE REACTIONS

The most common adverse reactions observed in clinical trials with use of Picato 0.015% on the face and scalp (≥2%) are local skin reactions (94%), application site pain (15%), application site pruritus (8%), application site infection (3%), periorbital edema (3%), and headache (2%).
The most common adverse reactions observed in clinical trials with use of Picato 0.05% on the trunk and extremities (≥2%) are local skin reactions (92%), application site pruritus (8%), application site irritation (4%), nasopharyngitis (2%), and application site pain (2%).
In post approval use of Picato gel, 0.015% and 0.05%, the following adverse reactions have been identified: hypersensitivity, allergic contact dermatitis, application site pigmentation changes, application site scarring, herpes zoster, chemical conjunctivitis, corneal burn, and Stevens-Johnson Syndrome. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are no available data on Picato gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Lactation: There are no data on the presence of ingenol mebutate in human or animal milk, the effects on the breastfed infant or the effects on milk production. Advise breastfeeding women to avoid accidental transfer of Picato gel to the nipple and areola area to prevent direct infant exposure.

Pediatric Use: The safety and effectiveness of Picato gel for actinic keratosis in patients less than 18 years of age have not been established.

You are encouraged to report side effects of prescription drugs to the FDA. Visit MedWatch: The FDA Safety Information and Adverse Event Reporting Program or call 1-800-FDA-1088.

You may also report side effects to LEO Pharma Inc. at 1-877-494-4536, option 1, or email [email protected].

For more information, please see U.S. FDA Full Prescribing Information for Picato gel.

About LEO Pharma

The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 92 million patients in 130 countries. In 2019, the company generated net sales of DKK 10,805 million. For more information about LEO Pharma, visit www.leo-pharma.com.

MAT-31589. May 2020.

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¹ Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75:54–62.

² Popovic B et al. Structural characterisation reveals mechanism of IL-13-neutralising monoclonal antibody tralokinumab as inhibition of binding to IL-13Rα1 and IL-13Rα2. J Mol Biol. 2017;429:208-219.