Lipidor signs agreement for clinical phase III study
STOCKHOLM, Sweden, 20th September 2023 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) has signed an agreement with Cliantha Research to conduct a phase III study with the drug candidate AKP02G2, for the treatment of psoriasis. The study is expected to begin recruitment of patients in the first half of 2024 and Lipidor hopes to be able to present study results already in December of the same year.
During the spring and summer, AKP02G2, the modified formulation of AKP02, underwent careful internal and external evaluation. The results have been very promising, and the properties of the new formulation mean that it can be expected to provide a stronger therapeutic effect compared to its predecessor AKP02.
At the beginning of the summer, the Swedish Medicines Agency made the assessment that AKP02G2 can be used directly in a new clinical phase III study, after which the planning work for such a study was intensified. The design of the study is based on experiences from the previous phase III study for AKP02, and Lipidor has chosen to collaborate with Cliantha Research, which is a reputable CRO (Clinical Research Organization) with solid experience in dermatological research.
"We are very pleased to be able to carry out the study together with Cliantha Research, which has previously conducted a large number of similar phase III studies, and has also received excellent references from our own network," says Lipidor's CEO Ola Holmlund.
In addition to selecting a CRO, the planning work for the clinical study has also included a process to select and start work with a manufacturer of clinical trial material (CMO). For CMO, Lipidor has chosen Medfiles Oy in Finland, which has initiated preparations for production of the clinical trial material so that this can be available by the start of the study.
"I am convinced that with the help of Cliantha Research's clinical experience and Medfiles's commitment to the clinical trial material, we can carry out this study efficiently and with high quality," says Dr. Vibhu Rinwa, program manager at Lipidor.
A prerequisite for the phase III study to be carried out according to plan is that Lipidor is to have new funding in place.
The information was provided for publication by Lipidor’s CEO on 20 September 2023 at 2.55pm (CEST).