The pipeline for atopic dermatitis therapeutic is expected to witness significant growth in the future due to rising prevalence of the disease and food allergies, which is expected to impact around 20.0% of the global population in the developed countries, according to a research done by Nutrition and Health Department, Nestle Research Centre, in 2015. Many generic drugs are already being given, but with the introduction of biologics, particularly interleukin (IL) inhibitors, is expected to be an effective future strategy for the drug manufacturers. Currently, the physicians have no other pharmacological options, which leads to treatment failure and intolerability to cyclosporine can occur when physicians prescribe off-label therapies.
Atopic dermatitis is a chronic inflammatory skin disease, associated with hyperactivity to environmental triggers. It has been concluded from the various clinical findings of atopic dermatitis that pruritus, facial and extensor eczema in infants and children, flexural eczema in adults and chronicity of the dermatitis in many immunologic and inflammatory pathways are activated and complex interaction among susceptibility genes occurs which led to defect in skin function, systemic and local immune responses. It also gives rise to asthma, food allergy and allergic rhinitis, which is characterized by elevated serum IgE levels and peripheral eosinophilia. There are two forms of atopic dermatitis. Extrinsic atopic dermatitis, which includes expression of skin homing receptor, cutaneous lymphocyte associated antigen by memory T cells produce Th2 cytokines. IL-13 and IL-4 are the isotypes which induce IgE synthesis and IL-5 and play an important role in eosinophil development. The T cells associated with cutaneous lymphocyte associated antigen produce abnormally low level of IFN-γ which inhibit the Th2 cell function. In intrinsic atopic dermatitis, IL-13 and IL-4 production is less.
Most of the companies are conducting clinical trials for the development of compound for the treatment of atopic dermatitis. Amorepacific Corporation is developing a compound PAC-14028 as a topical cream formulation. PAC-14028 is a non-vallinoid transient receptor potential vanilloid 1 antagonist. Dermata Therapeutics is developing a compound for the treatment of atopic dermatitis, DMT210, a topical gel which is in Phase II. DMT210 is structurally designed to mimic amino acid tail of C-terminus of G-proteins. Incyte Corporation is introducing a compound INCB018424 which is in Phase II development stage. INCB018424 is a Janus kinase Type 1 and Type 2 inhibitor. Topical corticosteroids and immunosuppressant (e.g. calcineurin inhibitors) are the current treatment options for atopic dermatitis but its long-term use can often lead to side effects. Corticosteroids dominated the atopic dermatitis market in 2013, which generated large revenue and it is mostly used as a first line of treatment. The calcineurin inhibitors is also expected to grow faster as the need for safer and well-tolerated therapeutics remains significant. Dupilumab is a biologic product of Sanofi/Regeneron and is expected to rebuild a severe treatment landscape and it is also one of the main driver of atopic dermatitis pipeline.
In June 2016, Regeneron Pharmaceuticals, Inc. collaborated with Sanofi to produce Dupilumab, was used in the treatment along with topical corticosteroids, alone in long term phase III trials. Leo Pharma collaborated with AstraZeneca plc and acquired the global license for tralokinumab in skin diseases and exclusive license for brodalumab in Europe.
Some of the key players having a pipeline of atopic dermatitis therapeutics include LEO Pharma, Mylan Laboratories Limited, Valeant Pharmaceuticals International, Inc., Bayer AG and Encore Dermatology, Inc., Allergan, Inc., Chester Valley Pharmaceuticals, Inc., Eisai, Inc., Dermik Laboratories, Inc., Genentech, Inc., Amgen, Inc. etc.