Lipidor updates on Phase III study of AKP02 in treatment of psoriasis – half of … – Press Release


STOCKHOLM, May 20, 2022 /PRNewswire/ — Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) announces that half of the patients have now been enrolled in the Phase III study of AKP02 skin spray for mild to moderate psoriasis, with the last patient expected to begin treatment in June 2022. Topline results from the Phase III study are expected during the third quarter of 2022.

On 26 January, Lipidor announced that the first psoriasis patients had been enrolled in the company’s Phase III clinical trial of AKP02 cutaneous spray. The observer-blind and placebo-controlled Phase III study included a total of 294 patients. The aim of the study is to show a good therapeutic effect for treatment of mild to moderate psoriasis on both body and scalp. The Phase III study also measures quality of life, and patient satisfaction, to demonstrate the associated benefits of AKP02 that may be significant for future commercialization. The trial is fully funded with existing cash and is conducted by Cadila Pharmaceuticals, which successfully completed the Phase III study with its predecessor AKP01.

With the current patient recruitment rate, the last patient is expected to commence treatment in June and topline results from the Phase III study with AKP02 are expected in the third quarter of 2022. Lipidor and the company’s commercial partner RELIFE, a company in the Menarini group, are already working together to ensure that the two topical drug candidates, AKP01 and AKP02, become available for treatment for mild to moderate psoriasis in Europe, the CIS countries and Turkey. Conditions for new commercial agreements are continuously investigated and there is great interest from the market.

The psoriasis candidate AKP02 combines calcipotriol and betamethasone dipropionate and is based on Lipidor’s patented AKVANO® technology. Lipidor has elected to compare the sprayable drug candidate AKP02 with Enstilar, which is a commonly prescribed foam preparation for topical treatment of…