Atopic dermatitis - Competitive Landscape, 2023

Atopic dermatitis - Competitive Landscape, 2023

DelveInsight’s, “Atopic dermatitis - Competitive landscape, 2023,” report provides comprehensive insights about 100+ companies and 110+ drugs in Atopic dermatitis Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

Global coverage

Atopic dermatitis: Understanding

Atopic dermatitis: Overview

Atopic dermatitis (AD) also called eczema, is a chronic condition and the most common type of skin inflammation that usually starts in early childhood, but can occur at any age and can be recurrent or persistent throughout life. In the word ‘dermatitis,’ ‘derm’ means ‘skin’ and ‘itis’ means ‘inflammation.’ Thus, dermatitis is a skin inflammation characterized by itchiness, redness and a rash caused by genetics, an overactive immune system, infections, allergies, and irritating substances. Half of the patients with moderate-to-severe eczema also have asthma, hay fever (allergic rhinitis), and food allergies. It is the most common chronic skin disease in children.

The primary symptom of AD is dry, itchy skin that often turns into a red rash. During a flare, AD becomes a red, itchy rash. Many different physical and internal factors can trigger an eczema flare-up. AD presents different symptoms depending on the age of the person. Itching is the hallmark of AD; more than 85% of people with the condition experience this distressing symptom every day.

The pathophysiology of AD is complex and multifactorial, involving elements of barrier dysfunction, alterations in cell-mediated immune responses, IgE mediated hypersensitivity, and environmental factors. Loss of function mutations in filaggrin has been implicated in severe AD due to a potential increase in trans-epidermal water loss, pH alterations, and dehydration. Other genetic changes have also been identified which may alter the skin’s barrier function, resulting in an AD phenotype. The imbalance of Th2 to Th1 cytokines observed in AD can create alterations in the cell-mediated immune responses and promote IgE mediated hypersensitivity, both of which appear to play a role in the development of AD. Eczema can be characterized by spongiosis which allows inflammatory mediators to accumulate. Different dendritic cells subtypes, such as Langerhans cells, inflammatory dendritic epidermal cells, and plasmacytoid dendritic cells, play a major role in developing the condition.

The diagnosis is based on signs and symptoms. Other diseases that must be excluded before making a diagnosis include contact dermatitis, psoriasis, and seborrheic dermatitis. It can significantly impact the quality of life, not just that of the patient, but family and friends as well. The itch can make it difficult to concentrate, and poor sleep can make people feel like zombies during the day. Also, Systemic Treatment s and precautions can take a toll on time, energy, and money. The condition usually improves or clears up if the substance causing the problem is identified and avoided. Although there is no cure, available Systemic Treatment s help ease the symptoms (American Academy of Allergy, Asthma & Immunology.

Currently, there is no cure for AD; however, it can be effectively managed with current treatment options. The pattern of the disease and its severity determine the kind of treatment the patient ought to receive. The current US, European and Japanese markets for AD are dominated by topical treatment options such as emollients, topical corticosteroids (TCS) + antibiotics, topical calcineurin inhibitors (TCIs), and systemic treatment such as immunosuppressant, corticosteroids, Dupixent (Dupilumab), and others (phototherapy).

Report Highlights

In April 2023, Aldeyra Therapeutics announced enrollment of the first patient in the Phase II clinical trial of orally administered RASP modulator ADX 629, an investigational new drug, for the treatment of atopic dermatitis.

In October 2022, Q32 Bio and Horizon Therapeutics announced that the first patient had been dosed in a randomized, double-blind, placebo-controlled, Phase II multi-center proof-of-concept study in adult subjects to evaluate the safety and efficacy of ADX-914 in persistent, moderate-to-severe atopic dermatitis (AD).

In September 2022, Nektar Therapeutics announced data presentations from two Phase Ib, proof-of-concept studies of rezpegaldesleukin (also known as LY3471851 or NKTR-358) in patients with atopic dermatitis (AD) at the 2022 European Academy of Dermatology and Venereology (EADV) Congress.

In August 2022, Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc, announced that they have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases.

In March 2022, Pfizer Inc. announced the completion of its acquisition of Arena Pharmaceuticals, a clinical stage company developing innovative potential therapies for the treatment of several immuno-inflammatory diseases.

In December 2021, the potential new atopic dermatitis drug that was licensed out by JW Pharmaceutical to Denmark-based LEO Pharma to enter Phase IIb dose-ranging clinical trial.

In June 2021, Amgen and Kyowa Kirin Co., Ltd. announced an agreement to jointly develop and commercialize KHK4083, which is Kyowa Kirin's potential first-in-class, Phase III-ready anti-OX40 fully human monoclonal antibody in development for the treatment of atopic dermatitis, with potential in other autoimmune diseases.

Atopic dermatitis: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function. Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa.

Product Description: OPZELURA

OPZELURA, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor. OPZELURA targets the signaling of key cytokines believed to contribute to inflammation and itch in AD. JAKs are intracellular signaling enzymes that act downstream of many inflammatory cytokines involved in AD pathogenesis. Ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

2. Company Overview: LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of 5,800 people, serving millions of patients across the world. In 2021, the company generated net sales of DKK 9,957 million.

Product Description: ADTRALZA

ADTRALZA (tralokinumab) is a high-affinity human monoclonal antibody developed to bind to and inhibit the interleukin (IL)-13 cytokine, which plays a role in the immune and inflammatory processes underlying atopic dermatitis signs and symptoms. ADTRALZA specifically binds to the IL-13 cytokine, thereby inhibiting interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL-13Rα2). ADTRALZA is approved for the treatment of adults and adolescents with moderate-to-severe AD in the European Union and approved for adults with moderate-to-severe AD in the United States, Great Britain, Canada, the United Arab Emirates, and Switzerland. ADTRALZA is marketed in the United States under the trade name ADBRY (tralokinumab-ldrm). Applications to extend the indication of Adtralza/Adbry to adolescents are currently under review with several agencies, including the US Food and Drug Administration (FDA).

Atopic dermatitis: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Cara Therapeutics

Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment to improve the lives of patients suffering Atopic Dermatitis. The corporate strategy is to leverage our first-in-class lead product, difelikefalin, to potentially treat pruritus across systemic, dermatologic, and neurologic disease categories. The company’s strategic priorities are to launch and maximize the commercial potential of KORSUVA injection and to develop oral difelikefalin across all categories of pruritus, thus changing how pruritus is treated in clinical practice.

Product Description: Difelikefalin

Cara Therapeutics is developing the first peripherally acting kappa opioid receptor agonist (KORA) called CR845 (Difelikefalin). CR845 is a potent peripheral kappa opioid receptor agonist with high selectivity over other opioid receptors in the body. The degree of kappa receptor selectivity displayed by CR845 ranks as best-in-class compared to all other previously developed compounds for this therapeutic target. CR845 exhibits potent analgesic, anti-pruritic (anti-itch) and anti-inflammatory properties in both human and animals. Since CR845 is intrinsically poor at penetrating the blood-brain barrier, it has shown to produce little to no CNS-mediated side effects that one sees with traditional CNS-acting mu opioids like nausea/vomiting, sedation, respiratory depression, abuse, addiction or euphoria. The drug is currently in Phase III stage of development for the treatment of patients with Atopic Dermatitis.

2. Company Overview: Kyowa Kirin

Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, the company apply cutting-edge science including expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – The company focus on purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity.

Product Description: KHK4083

KHK4083 is a potential first-in-class, anti-OX40 fully human monoclonal antibody for the treatment of autoimmune diseases, including atopic dermatitis. KHK4083 was first discovered by Kyowa Kirin, and is produced with the Company’s patented POTELLIGENT defucosylation technology to enhance its antibody dependent cellular cytotoxicity (ADCC) activity. The combination of ADCC and antagonist activity against OX40 may suppress inflammatory responses found to be the cause of Atopic Dermatitis. The drug has recently completed Phase II clinical trial for the treatment of patients with Atopic Dermatitis.

3. Company Overview: Bayer

Bayer is engaged in the discovery, development, manufacturing, and commercialization of products for human health, and agriculture. It provides medicines for cardiovascular diseases, women’s health, cancer, hematology, ophthalmology and other indications. It also strives to develop new molecules and technologies for use in the fields of medicine and modern agriculture. The company’s product portfolio includes prescription products, specialty pharmaceuticals, diagnostic imaging equipment, non-prescription (over the counter or OTC) products, seeds, crop protection solutions and non-agricultural pest control solutions. Bayer markets its healthcare and crop protection products essentially through wholesalers, pharmacies, hospitals and retailers. It operates through a network of subsidiaries in Asia-Pacific, Europe, North America, Latin America, Africa and the Middle East. Bayer is headquartered in Leverkusen, North Rhine-Westphalia, and Germany.

Product Description: Zabedosertib

Zabedosertib (BAY 1834845) is an IRAK4 inhibitor with immunomodulatory potential, which is a protein kinase involved in signaling innate immune responses from Toll-like receptors. The study treatment Zabedosertib (BAY1834845) is currently under development for the treatment of atopic dermatitis and other inflammatory diseases. It works by reducing the activity of a protein called IRAK4. IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells. By reducing the activity of IRAK4, the inflammation reactions are expected to be reduced. The drug is currently in Phase II stage of development for the treatment of patients with Atopic Dermatitis.

4. Company Overview: Alphyn Biologics

Alphyn Biologics is a clinical-stage dermatology company developing first-in-class multi-target therapeutics for severe and prevalent skin diseases based on its AB-101 platform. Alphyn's AB-101 platform has multiple bioactive compounds and therefore multiple mechanisms of action to support a robust pipeline of dermatologic therapeutics that have potential safety, efficacy and regulatory marketing authorization advantages. Alphyn is based in Annapolis, Maryland and Cincinnati, Ohio, and has a wholly owned Australia subsidiary. The company became operational in 2020.

Product Description: AB-101a

Topical AB-101a is expected to be the first to treat all of problems associated with Atopic Dermatitis (AD), namely AD’s immune response problems of inflammation, itch and damaged skin, and, bacterial problems including infection and problems caused by MRSA drug resistant bacteria. Current individual AD treatments do not target all the AD problems which results in current AD therapy requiring multiple products. AB-101a, based on its test results and mechanisms of action, is directly targeted to be the first complete solution for the millions afflicted with AD. AB-101a with its multiple bioactives and resulting Multi-Target Therapeutics™ technology is expected to treat all the problems of AD: AB-101a multiple mechanisms of action are expected to attack and eliminate inflammation, attack and eliminate itch and attack and kill Staph bacteria, its MRSA drug resistant variant and other bacteria with their drug resistant variants. AB-101a’s Multi-Target Technology, combined with its topical delivery, is expected to provide clear safety and efficacy advantages over current and experimental topical and systemic AD therapeutics.

5. Company Overview: VYNE Therapeutics

VYNE’s mission is to improve the lives of patients by developing proprietary, innovative, and differentiated therapies for the treatment of immuno-inflammatory conditions. The Company’s unique and proprietary pipeline includes access to a library of bromodomain & extra-terminal (BET) domain inhibitors licensed from In4Derm Limited. The BET inhibitor platform includes lead programs and access to a library of (BET) domain inhibitors for the potential treatment of immuno-inflammatory conditions.

Product Description: FMX114

FMX114 is VYNE’s proprietary tofacitinib and fingolimod combination gel formulation under investigation for the treatment of mild to moderate atopic dermatitis. FMX114 attempts to address both the source and cause of inflammation in AD by developing a distinct combination of tofacitinib (a Janus kinase Inhibitor aimed at reducing inflammation by inhibiting cytokine release from inflammatory cells) and fingolimod (Sphingosine 1-phosphate receptor modulator), which approaches the reduction of inflammation by inhibiting migration of the inflammatory cells and, in addition, may also directly support skin barrier recovery. Based on the Phase IIa results and subsequent analysis of a two-week open label extension period, the company believes that FMX114 may have an improved overall treatment effect on patients with more severe disease at baseline, and that FMX114 may have increased potential to effectively treat patients with more moderate-to-severe AD. The company is evaluating partnering opportunities for this program and intends to focus its resources on the BET inhibitor development programs.

6. Company Overview: MatriSys Bioscience

MatriSys Bioscience is leading the discovery and clinical development of a novel class of biopharmaceuticals to transform the treatment of inflammatory skin diseases. The groundbreaking technology platform identifies beneficial bacteria derived from healthy human skin to treat the millions of children and adults suffering from difficult to treat chronic skin diseases. With the lead clinical program in patients with Atopic Dermatitis the company is also rapidly advancing therapeutics for Acne and Rosacea.

Product Description: MSB-0221

MSB-0221 is a proprietary topical bacterial formulation containing a stabilized lyophilized topical preparation of Staphylococcus hominis, universal strain A9 (ShA9). The topical formulation is applied to the skin of patients, and the lyophilized bacteria ShA9 return to an active state and kill Staphylococcus aureus. This approach is a dramatic improvement over broad-spectrum antibiotics that destroy pathogenic bacteria but also kill beneficial bacteria by “friendly fire.”

Further product details are provided in the report……..

Atopic dermatitis Analytical Perspective by DelveInsight

In-depth Commercial Assessment: Atopic dermatitis Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition – deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

Atopic dermatitis Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy, development stage, and technology).

Atopic dermatitis Report Assessment

Company Analysis

Therapeutic Assessment

Pipeline Assessment

Inactive drugs assessment

Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

How many companies are developing Atopic dermatitis drugs?

How many Atopic dermatitis drugs are developed by each company?

How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Atopic dermatitis?

What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Atopic dermatitis therapeutics?

What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?

What are the clinical studies going on for Atopic dermatitis and their status?

What are the key designations that have been granted to the emerging and approved drugs?

Key Players

Eli Lilly and Company

Vanda Pharmaceuticals

Arcutis Biotherapeutics

Suzhou Connect Biopharmaceuticals

Dermavant Sciences, Inc.

Suzhou Zelgen Biopharmaceuticals

Reistone Biopharma

Kyowa Kirin

Cara Therapeutics

Kangstem Biotech

Arena Pharmaceuticals

Bellus Health

Tioga Pharmaceutical

BioMimetix

Botanix Pharmaceuticals

AOBiome

Aclaris Therapeutics

Asana BioSciences

Sanofi

Horizon Therapeutics

Evommune

Celgene Corporation

Allakos Inc.

Bayer

Alphyn Biologics

Argenx

Shulov Innovate for Science

Teres Bio

Qurient Co

Sun Pharmaceutical

Pfizer

Ichnos Sciences

Shaperon

Pyramid Bioscience

selectiON

GSK

Avixgen Inc

Brexogen

Fresh Tracks Therapeutics

Yuhan Corporation

Ribon Therapeutics

Biosion

HK inno.N Corporation

NovaCell Technology Inc.

Inmagene Biopharmaceuticals

Key Products

Lebrikizumab

Tradipitant

Roflumilast

CBP-201

Tapinarof

Jaktinib

SHR0302

Rocatinlimab

Difelikefalin

FURESTEM-AD inj

Etrasimod

BLU-5937

Asimadoline

BMX-010

BTX 1204

B244

ATI-1777

ASN002

Rilzabrutinib

ADX-914

EVO101

Cendakimab

Lirentelimab

Zabedosertib

AB-101a

ARGX-112

ZEP-3Na

TER-101

Q301

SCD-044

PF-07038124

ISB 830

HY209

PBI-100

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