August 20, 2024

Lipidor announces that clinical trial material for psoriasis candidate AKP02G2 has been released according to plan

STOCKHOLM, Sweden, 20th August 2024 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) today announces that the clinical trial material for the company's upcoming clinical Phase III study with the drug candidate AKP02G2 is ready and has been shipped to our CRO. It marks a critical milestone in the project plan and creates the conditions for the start of studies according to plan. The main aim of the study is to compare the therapeutic efficacy of AKP02G2 against mild to moderate psoriasis with a market-leading product.

Production of clinical trial material is an extensive exercise and a prerequisite for being able to carry out the clinical study. The process must ensure that the material is of the highest quality for use on humans.

"I note that our partner Oy Medfiles has done a first-class job in producing clinical trial material according to schedule. The purchase and completion of materials including their transportation is a critical process and we are very happy to have achieved this milestone in the project together," says Ola Holmlund, CEO of Lipidor.

Preparations for the study itself are also on track and, among other things, approval has already been obtained from the ethics committee for around half of the clinics.

The Phase III study will include 294 patients and is being conducted by Cliantha Research, a reputable CRO (Clinical Research Organisation) with extensive experience in dermatological research. The next major milestone is to initiate the work at the clinics and enroll the first patient to the study. We estimate that this will happen towards the end of next month.

Publication

The information was provided for publication by Lipidor’s CEO on 20th August 2024 at 1.50pm (CEST).