09 Sep 2021
Posted in Pharma
Drug developers recent interest in targeting CHE could boost better management over the next decade
The lack of approved treatments for chronic hand eczema (CHE) demonstrates that there is a clear need for more targeted therapies. However, based on the recent boost of interest by drug developers in targeting CHE, GlobalData, a leading data and analytics company, believes that great strides will be made over the next decade toward better management of the disease.
Poor quality of available therapies
Generally, the standard of care for CHE encompasses topical therapeutics such as emollients, calcineurin inhibitors, and high potency steroids. However, few cases resolve after these treatments. Moreover, moderate-to-severe cases are often resistant to topical therapeutics and require systemic options. Alitretinoin is the only marketed systemic therapy for treating CHE, but it is only approved in the 5EU*. It is used for the treatment of moderate to severe CHE and is often prescribed once it is clear that a patient is resistant to the very potent topical corticosteroids.
Ramla Salad, Pharma Analyst at GlobalData, comments: “Although it is an established drug for this indication, Key Opinion Leaders (KOLs) interviewed by GlobalData mentioned that alitretinoin does not work well on both hands and feet and its effectiveness is limited to treating the hands only. It is clear there is a major unmet need in regard to the treatment of this patient population.”
New options for CHE are in development
Recently there have some notable developments toward improving the care of CHE patients. These include the ongoing clinical development of Sanofi/Regeneron’s Dupixent (dupilumab), LEO Pharma’s delgocitinib, and Asana Biosciences’ gusacitinib.
Dupixent (dupilumab), an IL-4α receptor antagonist indicated for moderate-to-severe atopic dermatitis (AD), is being investigated in CHE. Currently, there are three ongoing trials investigating Dupixent for the treatment of CHE: one industry-sponsored Phase III (NCT04417894) and two-Phase II trials (NCT03861455, NCT04512339) sponsored by academic institutions.
Salad comments: “Although data from these trials is not expected until 2022 and beyond, data from a small, observational study has suggested that Dupixent may be efficacious in patients with moderate-to-severe hand eczema. In a study, 60% of patients achieved a minimum improvement of 75% in Hand Eczema Severity Index (HECSI) and 96% of patients demonstrated some significant degree of improvement in HECSI. GlobalData believes that Dupixent may hold promise for patients with chronic hand eczema but requires evaluation in a larger study.”
Delgocitinib, a topical pan-JAK inhibitor, is currently marketed in Japan under the brand name Corectim by Japan Tobacco for all severities of AD. However, LEO Pharma has recently begun pursuing the drug’s development specifically for CHE in the US and 5EU. In 2021, LEO Pharma initiated three Phase III trials, DELTA 1 (NCT04871711), DELTA 2 (NCT04872101), and DELTA 3 (NCT04949841), evaluating the clinical profile of delgocitinib in adults with moderate to severe CHE.
KOLs interviewed by GlobalData expressed that even though earlier data from Japan Tobacco is based on mild to moderate patients in Japan, they were hopeful this new JAK inhibitor would offer a safe topical option for patients with more severe CHE.
Another notable Phase III-ready agent is gusacitinib, an oral JAK/SYK inhibitor targeting moderate-to-severe CHE. RADIANT, a Phase IIb trial of gusacitinib in CHE, has reported promising results, with dose-dependent and clinically meaningful improvements in hand eczema compared to placebo. Phase III development is expected to commence in H2 2021.
Salad continues: “KOLs interviewed by GlobalData expressed optimism for gusacitinib’s potential to change the treatment paradigm for CHE sufferers. Considering the growing profile of CHE in the AD community and the strong pipeline activity, GlobalData believes that gusacitinib, delgocitinib, and Dupixent will greatly improve the management of this burdensome disease.”
5EU* – France, Italy, Spain, Germany, and UK