Statement from Lipdor´s CEO

It is an exciting and crucial period for Lipidor, as we are now approaching the publication of the results from our ongoing Phase III study.

Second half of the year

During the second quarter 2024, we were able to announce that we had successfully completed a successful refinancing of the company with the aim of being able to conduct a new Phase III study of the updated drug candidate AKP02G2. The focus for the second half of 2024 has been to start the clinical study according to the ambitious timetable that we set together with our new CRO partner, Cliantha Research.

In September, the first patient was recruited to the study, and after a somewhat slow start-up, patient recruitment accelerated significantly towards the end of the year. It is particularly gratifying that almost all patients screened for the study also qualify for participation. We are now in the final phase of recruitment and will announce to the market when the study is fully recruited.

Phase III clinical trial

The purpose of the ongoing clinical trial is to compare the therapeutic effect of our sprayable and quick-drying drug candidate in patients with mild to moderate psoriasis, with a market-leading preparation. The study, which includes 294 patients, and is conducted in India, aims to generate the results that will enable Lipidor’s license partner, Menarini/RELIFE, to register and launch a drug.

After this year’s new share issue, the company has many new shareholders, including a new major shareholder in the form of Life Science Invest Fund. It is gratifying and important that another committed and long-term owner has been added. The owner Jan Poulsen has also undertaken to lead the work of Lipidor’s Nomination Committee.

Future prospects

In parallel with the study, we are preparing for the next step in development, in which the submission of a registration application will be an important milestone. Although Lipidor will not directly submit the application, it is our responsibility to ensure that all necessary documents and activities on our part comply with the regulatory requirements.

In the event of a positive study result, the conditions are in place to be able to register a product together with Menarini/RELIFE that has good conditions to compete with the current market-leading product. AKP02G2’s properties complement the existing offering and are considered to provide several important patient benefits.

The company is now at a very crucial stage in the development process, and we look forward to receiving the results that can pave the way for AKP02G2 towards the market.

Ola Holmlund
CEO
28th February 2025