Emerging Biopharma’s Contribution in Atopic Dermatitis Space

Nov 24, 2022

The Atopic Dermatitis (AD) therapeutics market boasts an impressive pipeline of 150+ drugs, which is indicative of the spotlight this therapy area is receiving.

Innovations in biomedical sciences and technology fuel the opportunity to transform R&D for new-drug development holistically. Our understanding of biology is expanding enormously alongside the increased identification of novel targets and their associated modalities. With drug development expenditure continuing to rise and a shrinking pipeline portfolio of new chemical entities (NCEs), drug developers are focusing on conducting rigorous R&D activities, especially conducting many clinical trials to minimize the failure rate. Collectively, the estimated average cost of bringing a drug to market (including drug failures) is now around $2.6 billion. More than 150 drugs are in various stages of development for atopic dermatitis (AD). Roughly, the cumulative R&D investment translates to a whopping $390 billion for these molecules before they reach the market. This indicates many global, regional, and local pharma/biotech companies are actively engaged in bringing novel drugs for treating atopic dermatitis, which has high unmet needs with the current therapies. 

Approximately the cumulative R&D expenditure translates to $175.5 & $214.5 billion for early-stage and late-stage assets, respectively, which are being under investigation for atopic dermatitis. 

The Atopic Dermatitis (AD) therapeutics market boasts an impressive pipeline of 150+ drugs, which is indicative of the spotlight this therapy area is receiving. The pipeline includes 150+ pipeline drugs in various stages of development (clinical & non-clinical). Of these, 43% (66 drugs) are in non-clinical, 16% (25 assets) are in Phase I trials, 33% (51 assets) in Phase II trials, and 7% (11 assets) in Phase III trials. Biologics comprise 50.33% of these agents (77 assets), while 49.67% are small molecules (76 assets). 

The key molecule types that atopic dermatitis pipeline comprises 50.33% (77 drugs) of biologics and 49.67% (76 drugs) of small molecules. 

Potential Biologics Likely to Enter into the market: 

Potential Small Molecules Likely to Enter into the market: 

 

There is an array of targets within the biologic group, including various interleukin (IL) inhibiting biologics. Key late-stage IL inhibitors include Eli Lilly’s lebrikizumab (anti-IL-13), AbbVie’s risankizumab (anti-IL-23), and KeyMed Bioscience’s CM-310 (anti-IL-4). These assets are following in the footsteps of Sanofi/Regeneron’s Dupixent (dupilumab), a first-in-class IL-4/IL-13 dual inhibitor approved for the treatment of moderate-to-severe AD since 2017. With global reported sales of over $6.1bn last year, Dupixent has seen strong uptake in AD, signaling the market’s readiness for other IL inhibitors. 

Another notable class among the pipeline biologics are anti-OX40 targeting assets. Among these assets, Kyowa Kirin/Amgen’s rocatinlimab is ready for assessment in a Phase III study, while Kymab’s KY-1005 and Ichnos Sciences’ ISB-830 are still completing Phase II trials. The anti-OX40 class uses a completely novel mechanism of action, and early data suggests it could disrupt the AD treatment paradigm. All biologics in development for AD are administered subcutaneously. Although injections may not be preferred by some, they can be an attractive option for patients because they are administered less frequently (every one to four weeks). 

There are also several small-molecule agents in the early and late-stage pipeline for AD. Numerous Janus kinase (JAK) inhibitors and phosphodiesterase-4 (PDE4) inhibitors are in later stages of development, as well as a few from novel classes such as the sphingosine 1-phosphate receptor (S1PR) modulators and Bruton Tyrosine Kinase (BTK) inhibitors. 

JAK inhibitors provide a more convenient option for patients who prefer topical or oral assets for treatment. There are currently seven JAK inhibitors in varying stages of clinical development for AD, four of which are topical assets and three of which are orally administered. Key late-stage JAK inhibitors include three oral assets, Asana Bioscience’s gusacitinib, InnoCare Pharma’s ICP-332, and E-nitiate Biopharmaceuticals QY-201, as well as four topical agents, namely LEO Pharma’s delgocitinib, VYNE Therapeutic’s FMX-114 and Pfizer’s PF-07295324 and PF-07259955. While the majority of JAK inhibitors in late-stage development are targeting moderate-to-severe patients. 

Another interesting class in development for atopic dermatitis is the S1PR modulators. Although S1PR assets are a minority in the pipeline, they have the potential to offer a unique treatment option for patients. Arena Pharmaceuticals’ etrasimod is a progressive new oral therapy within this class that is ready for Phase III, with a pivotal study program expected to begin in the second half of this year. There are no S1PR modulators on the market for AD, so etrasimod would be a first-in-class agent if it is brought to market. 

Some of the companies who are highly active and have potential late-stage molecules with novel mechanism of action for AD are Eli Lilly and Company, Dermira, AstraZeneca, Pfizer Inc, Bristol-Myers Squibb Co, Leo Pharma, Kyowa Hakko Kirin, KeyMed Biosciences, Dermavant Sciences, Sanofi, and Asana Biosciences among others. 

The key late-stage molecules which are being under investigation includes rocatinlimab (Kyowa Hakko Kirin), roflumilast (Arcutis Biotherapeutics), lebrikizumab (Eli Lilly/Dermira Inc), tradipitant (Vanda Pharmaceuticals), Tapinarof (Dermavant Sciences), delgocitinib (Leo Pharma), JW-100 (Jupiter Therapeutics), Etrasimod (Pfizer), Orismilast (Union Therapeutics) and many others. The most anticipated upcoming events in AD include launch of delgocitinib in Europe and Canada from 2024. 

 

Arizton’s analysis of the AD pipeline suggests there are numerous promising drugs under development for various age groups and severities of AD. It is expected this intense drug development and clinical activities is likely to disrupt and completely transform the exiting therapeutic options for AD and over the next decade with a better safety and efficacy scores compared to the existing treatment options. 

 

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