Denmark-based pharmaceutical company Union Therapeutics has shared data from its ADESOS Phase 2b study evaluating orismilast as an oral treatment for moderate- to-severe atopic dermatitis (AD).

Results of the study were shared at the inaugural Revolutionizing Alopecia Areata, Vitiligo, and Eczema (RAVE) 2024 conference, which took place in Chicago from June 8-10.

Orismilast is a first-in-class Phosphodiesterase-4 (PDE4) inhibitor that targets PDE4B/D subtypes linked to inflammation. It was evaluated as an oral treatment in 233 patients with AD.

PDE4 inhibitors block the enzyme PDE4 from degrading cyclic adenosine monophosphate (cAMP) in cells, which increase cAMP levels and have anti-inflammatory effects.

The US Food and Drug Administration (FDA) designates two markers for the efficacy of dermatological products in AD: lesional efficacy of IGA 0/1 (Investigator Global Assessment of completely clear or almost clear skin) by the product; and a four-point or greater reduction (NRS≥4) of ‘itch effect’ on a ten-point scale (PPNRS).

All three doses of orismilast administered in the patient cohort met the designated endpoints outlined by the FDA.

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The lowest dose of 20mgs was enough for most patients to meet the FDA-designated endpoints, with a four-point or more itch reduction achieved by week two for more than a third of patients, with an overall baseline of 7.4/10.

“Now we need to repeat this into Phase III,” said Union Therapeutics CEO Dr. Kim Kjoeller.

“We have scheduled an an End of Phase 2 (EoP2) meeting with the FDA and have already submitted the briefing package which outline plans of the Phase III programme to see if the FDA agrees with the outlined endpoints and patient population.”

In March 2024, Union published results from its OSIRIS Phase 2 study of the effect of orismilast on inflammatory skin condition Hidradenitis suppurativa (HS). Fast Track designation was received from the FDA in January 2023 for treatment of the condition.

In addition to the  AD indication, the privately held company currently has orismilast in active development for six immunological or dermatological indications, as per GlobalData’s Pipeline Drugs database.