Those with the disease can develop lesions with erythema and itching, leathery skin, papules and sore, cracked skin. As an autoimmune disease, pathogenic T lymphocytes form and attack healthy cells as a result of a failure of the body’s immune regulatory mechanisms.
A potential new treatment is being developed by Nektar Therapeutics.
Rezpegaldesleukin targets the interleukin-2 receptor complex; with the aim of stimulating the proliferation of regulatory T cells, it’s hoped that this will stop the immune dysregulation.1
It is a pegylated version of a recombinant form of the human IL2 hormone that can be given as a self-administered injection. Clinical data have been updated after errors in the original calculations came to light when raw data were transferred back to Nektar from former partner Lilly after their collaboration was terminated.2
In the Phase Ib study, 43 adult patients with moderate to severe atopic dermatitis affecting at least 10% of the body’s surface area were given 12 µg/kg, 24 µg/kg or a placebo.
Those treated with the drug had dose-dependent improvements in Eczema Area and Severity Index (EASI), Validated Investigator Global Assessment (vIGA), Body Surface Area (BSA) and Itch Numeric Rating Scale (NRS) after 12 weeks (compared with the placebo).
These improvements were sustained for 36 weeks after dosing. At the highest dose, 75% of patients were responders according to the Daily Life Quality Index (DLQI) and 65% based on the Patient Oriented Eczema Measure (POEM).
The proportions at the lower dose were 46% and 50%, respectively. These results, again, were generally sustained (56%/25% and 70%/22%, respectively) throughout the 36 week follow-up.
For the placebo group, the figures were 30% after 12 weeks and 33% after 48 weeks. The drug was well tolerated, with all treatment-emergent adverse events in the study drug arms being mild to moderate; there were no severe or serious adverse events.
The most common were mild to moderate injection site reactions. Two Phase II studies are now planned, one in atopic dermatitis and a second in alopecia areata. The trial design for the atopic dermatitis study has been reported.3
References
- C. Fanton, et al., J. Transl. Autoimmun. 5, 100152 (2022).
- J. Silverberg, et al., EADV Congress 2023, Abstr. 6685.
- J. Silverberg, et al., EADV Congress 2023, Abstr. 6218.
