July 11, 2022

Lipidor’s Phase III study of AKP02 for treatment of psoriasis now fully recruited, results expected Q3 2022

Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) can today announce that the last patient has been enrolled in the ongoing Phase III study of AKP02 against mild to moderate psoriasis. The recruitment is thus complete. Results from the study are expected in the third quarter of 2022.

“We are very pleased to have completed patient recruitment in this important clinical study and have therefore achieved another significant milestone. We look forward to presenting the results from the study during the third quarter of this year,” says Ola Holmlund, CEO of Lipidor.

The observer-blind and placebo-controlled Phase III clinical trial of AKP02 cutaneous spray covers a total of 294 patients and the last patient has now started treatment. The study's primary goal is to demonstrate good therapeutic efficacy for the treatment of mild to moderate psoriasis on both the body and scalp. Among the secondary objectives, the Phase III study also measures perceived quality of life and patient satisfaction to demonstrate associated patient benefits.

The psoriasis candidate AKP02 combines calcipotriol and betamethasone dipropionate and is based on Lipidor's patented AKVANO® technology. Lipidor has chosen to compare the sprayable drug candidate AKP02 with Enstilar, which is one of the market-leading preparations for topical treatment of psoriasis. AKP02 contains the same combination of active substances as Enstilar. The trial is conducted by Cadila Pharmaceuticals, which successfully completed the Phase III study of Lipidor's monotherapy product AKP01 containing calcipotriol alone.

Positive results from the study generate a milestone payment in accordance with the licence agreement signed in 2021 with RELIFE S.r.l., a company in the Menarini Group, for Europe, the CIS countries and Turkey.

The information was provided for publication by Lipidor’s CEO on 11 July 2022 at 08.30am CEST.