Lipidor Agrees Terms with Cadila Pharmaceuticals for Phase III Study

The study is aimed at demonstrating the equivalent therapeutic efficacy with existing medicines for mild to moderate psoriasis.

FREMONT, CA: Lipidor AB, entered into an agreement with Cadila Pharmaceuticals, a leading Indian pharmaceutical company with extensive CRO capacity, to conduct a Phase III study for Lipidor's drug candidate AKP-02. The study is expected to commence in the first quarter of 2021 with final reporting in the first quarter of 2022. AKP-02 is an antipsoriasis medicine that combines the active substances calcipotriol and betamethasone with Lipidor's spray-based AKVANO technology. In 2017, the market for combination drugs reached USD 580 million per year, and Lipidor is looking to capitalize on the same and stake claim to a significant market share when the drug reaches the market.

"We're very pleased to announce that we have entered into an agreement to carry out a registration-based Phase III study for AKP-02, Lipidor's combination drug candidate against psoriasis. Through the successful Phase III study for AKP-01, Cadila has shown that they can effectively recruit patients, administer dosing and report clinical study results. The experience of AKP-01 means that we have high hopes for effective cooperation and a successful study," said Ola Holmlund, Lipidor CEO. Lipidor previously announced its intentions to conduct an entirely self-funded Phase III study with the drug candidate AKP-02 in May 2020. An agreement has now been reached with Cadila Pharmaceuticals for the implementation of the study.

The company highlighted that the Phase III study will involve 270 patients and will be conducted in India on patients with various skin types. The study is aimed at demonstrating the equivalent therapeutic efficacy with existing medicines for mild to moderate psoriasis. The observer-blind and placebo-controlled trial is scheduled to be completed in the fourth quarter of 2021. Lipidor has already collaborated with Cadila regarding the drug candidate AKP-01, and this new agreement now strengthens that cooperation. Lipidor's existing funds will cover the cost of the Phase III study.

"The market has shown great interest in AKP-02 and by self-funding the implementation of the Phase III study, we will maximize the benefits of later out-licensing. We continue to see great potential in our first drug candidate AKP-01, and the opportunity to now discuss AKP-01 and AKP-02 in a package makes us an even more attractive partner for pharmaceutical companies that can take our products through registration for sale," concluded Ola Holmlund.