Lipidor applies to the Indian Medical Products Agency to start a Phase III study of AKP02G2
STOCKHOLM, Sweden, 20th December 2023 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) announces today that the company, through its partner Cliantha Research, has submitted an application to the Indian Medical Products Agency to start a Phase III study with the drug candidate AKP02G2. The main purpose of the study is to compare the therapeutic effect of AKP02G2 with Enstilar in the topical treatment of mild to moderate plaque psoriasis.
The drug candidate AKP02G2 combines calcipotriol and betamethasone and is based on Lipidor's patented AKVANO® technology. The aim of AKP02G2 is to offer a patient-friendly spray-based form of treatment for mild to moderate plaque psoriasis.
AKP02G2 is a further development of AKP02, which underwent a clinical phase III study in 2022. Experience from this study, together with development work and preclinical studies conducted in 2023, has led to a new formulation that is expected to produce an improved effect compared to AKP02.
The registration-based Phase III study with AKP02G2 is planned to include 294 patients and will be conducted by Cliantha Research, a reputable CRO (Clinical Research Organization) with solid experience in dermatological research.
The aim of the Phase III study with AKP02G2 is to demonstrate good therapeutic efficacy in comparison to Enstilar, in the treatment of mild to moderate plaque psoriasis on both the body and scalp. Enstilar is a commonly prescribed preparation in foam form for the topical treatment of psoriasis and contains the same combination of active substances as AKP02G2.
A prerequisite for the Phase III study to be able to start according to plan is that Lipidor will have new funding in place.
The information was provided for publication by Lipidor’s CEO on 20th December 2023 at 3pm (CET).