LEO Pharma begins clinical trial of CHE treatment, delgocitinib

Chronic hand eczema (CHE) is a common skin disorder that affects an estimated 1-5% of the general population. The non-infectious skin disorder usually causes itching, swelling, blisters, and pain to affected patients and can develop into a chronic condition if left untreated.

Recently, Danish pharmaceutical company, LEO Pharma A/S has come up with an investigational topical treatment ‘delgocitinib’ for patients with moderate-to-severe CHE. With an aim to study the efficacy of the novel treatment, the company has announced enrolled its first adult patient in its Phase 3 clinical trials.

How does delgocitinib work?

Delgocitinib inhibits the activation of the JAK-STAT pathway that plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases. However, delgocitinib is an investigational therapy under clinical development and is yet to attain approved by regulatory authority.

What does the clinical trial entail?

The primary objective of the Phase 3 clinical trials (DELTA 1 and DELTA 2) is to study the efficacy of delgocitinib cream 20 mg/g (twice-daily) compared to vehicle as a treatment for moderate-to-severe CHE in adults.

According to Dr. Sibylle Schliemann, Lead Investigator for DELTA 2 & Consultant, Department of Dermatology, University Hospital Jena, “Currently there are limited available treatment options for moderate-to-severe CHE. The initiated clinical trials will evaluate the efficacy of delgocitinib cream as a new treatment option for adult patients with moderate-to-severe CHE.”

Dr. Jörg Möller, Executive VP, Global Research & Development, LEO Pharma, mentioned “The Phase 2b CHE clinical trials on delgocitinib cream has shown positive results and they are now focusing on a larger Phase 3 clinical development program to learn if it could offer more benefits to adult patients”.

Dr. Möller added that “LEO Pharma is committed on developing advanced therapies to help improve patient’s lives by offering more treatment options for skin diseases”.

Source Credit: https://www.businesswire.com/news/home/20210517005624/en/LEO-Pharma-initiates-the-first-Phase-3-clinical-trial-with-delgocitinib-cream-in-adult-patients-with-moderate-to-severe-chronic-hand-eczema-CHE