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Lipidor announces results from the company's clinical Phase III study of AKP02 for psoriasis
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Läkemedel & Handel |
STOCKHOLM 28 October 2022 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) announces today that the company's Phase III study did not achieve the study's primary goal of achieving non-inferiority of therapeutic efficacy in the treatment of psoriasis compared to the reference product. However, AKP02 shows clearly better efficacy than placebo. The study compared AKP02 with a market-leading preparation for topical treatment of mild to moderate psoriasis.
The primary goal of the study was to show good therapeutic efficacy for the treatment of mild to moderate psoriasis on both the body and scalp. The study compared the psoriasis candidate AKP02 with placebo and Enstilar, which is one of the market-leading preparations for topical treatment in psoriasis. The comparison product contains the same combination of active substances (calcipotriol and betamethasone dipropionate) as AKP02.
For the primary evaluation of efficacy, the percentage change in PASI value from baseline to completion of treatment was used. PASI (Psoriasis Area and Severity Index) is an established scale that provides a general assessment of the severity of psoriasis symptoms by combining values for erythema, plaque thickness and scaling, in relation to the affected body surface.
The results of the study show that the average change in PASI is -55.6% for AKP02, -13.9% for placebo and -63.5% for Enstilar. The primary analysis thus shows that AKP02 is superior to placebo but that it does not achieve non-inferior therapeutic effect in comparison with Enstilar.
"Naturally we are disappointed that the Phase III study of the combination drug AKP02 did not achieve its primary goal. Previous positive results from the Phase III study of AKP01, which is based on calcipotriol alone, show that the AKVANO® formulation platform works well for the treatment of psoriasis. I would like to emphasize that we continue to have high confidence in AKVANO®," says Ola Holmlund, CEO, Lipidor AB.