Lipidor AB (publ) is targeting a new Phase III study of the drug candidate AKP02 in 2024. Data from the earlier completed clinical study with AKP02 has been analyzed, and a way forward is clear. On 28th October 2022, Lipidor announced that the combination product AKP02 for the treatment of psoriasis did not fully meet the Phase III study's primary endpoint of non-inferiority compared to the reference product.

The study compared AKP02 with Enstilar, the market-leading product for topical treatment of mild to moderate psoriasis. The products contain the same active ingredients, calcipotriol and betamethasone dipropionate. AKP02 was very close to achieving equivalent therapeutic efficacy with the reference product.

An in-depth analysis, examining why the compared preparations differ in efficacy, has produced an explanatory model that is now undergoing a verification program. The model is based on the interaction of the formulation with the different skin layers, and how this affects the deposition and efficacy of the active substances. An updated AKP02 formulation with optimized properties is now being externally verified, together with a number of reference formulations.

The partial results extracted so far in the preclinical work clearly indicate that the proposed corrections provide the desired effect. Work continues to provide further support for the change in formulation and thus increase the chances of success in a new study.