Lipidor – Swedish Medical Products Agency confirms clinical plan for new version of AKP02
STOCKHOLM, Sweden, 22nd June 2023 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) announced today that the Swedish Medical Products Agency (“MPA”) considers that AKP02G2, a modified version of the company's drug candidate AKP02 for the treatment of psoriasis, can be used in a new Phase III clinical study. This means that no further clinical studies with AKP02G2 will be needed before a new Phase III study can be initiated.
The company has conducted a scientific advisory meeting with preclinical, clinical and quality experts at the MPA. The changes in the composition of AKP02 presented are not considered by the MPA to require further clinical studies before initiating a Phase III study.
The main purpose of the planned study is to compare the therapeutic effect of AKP02G2 for mild to moderate psoriasis with the market-leading product Enstilar, with the intention of providing a basis for a first-stage market authorization in Europe.
According to the MPA, if the study can demonstrate comparable efficacy to Enstilar after 4 weeks in this study, the results can be extrapolated so that AKP02G2, like Enstilar, can be prescribed for maintenance treatment for 52 weeks (treatment twice a week).
"We are of course very pleased with the MPA's announcement,” says Ola Holmlund, Lipidor CEO. “Planning for the upcoming Phase III study with AKP02G2 is therefore entering a new phase. The announcement also means we can continue the completion of preclinical documentation and proceed directly to the new Phase III study, starting in Q2 2024."
The planning of the clinical study also includes a process for selecting the clinical trial material manufacturer (CMO) and the clinical trial organization (CRO).
The information was provided for publication by Lipidor’s CEO on 22 June 2023 at 8.30am (CEST).