Phase III Trial of AKP02 for Treating Psoriasis Begins

Lipidor’s Phase III study of drug candidate named AKP02 for treating psoriasis has been approved by the Indian Medical Products Agency and is ready to begin.

Study included 294 patients and is being conducted at twelve clinics in India. The trial is fully funded with existing cash and is conducted by Cadila Pharmaceuticals, a leading Indian pharmaceutical company with extensive contract research organizational capacity.

‘The purpose of the Phase III study with AKP02 is to demonstrate good therapeutic efficacy for the treatment of mild to moderate psoriasis on both the body and scalp.’
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The aim with AKP02 is to offer a patient-friendly, spray-based treatment for mild to moderate psoriasis.

Drug Lipidor and the Studies Based on the Drug

The drug candidate AKP02 combines calcipotriol and betamethasone and is based on Lipidor’s patented AKVANO® technology. Positive results from the Phase III study with the drug candidate AKP01, based solely on calcipotriol, show that Lipidor’s AKVANO® technology works well for the treatment of psoriasis.

The preclinical studies show that betamethasone works well with AKVANO® — a positive requirement for the second drug candidate, which is a combination of both calcipotriol and betamethasone.

The purpose of the Phase III study with AKP02 is to demonstrate good therapeutic efficacy for the treatment of mild to moderate psoriasis on both the body and scalp.

Psoriasis About
Psoriasis is a recurrent and complex inflammatory skin disorder that can have tremendous physical and psychological impact on the sufferer

Lipidor has chosen to compare the sprayable drug candidate AKP02 with Enstilar which is a commonly prescribed preparation in foam form for topical treatment of this indication and which contains the same combination of active substances as AKP02.

To reach a larger patient population, the scalp has also been included in the study. Psoriasis on the scalp, which often is affected, can consist of anything from weak to severe scale formation and cause varying degrees of itching.

The study will also measure quality of life and patient satisfaction in order to demonstrate associated benefits of AKP02. The observer-blind and placebo-controlled Phase III study is expected to have the first patient in-treatment during this fall with reporting in the first half of 2022.

Lipidor’s partner Aurena Laboratories will be responsible for the commercial production of the product.

"We have high hopes for a successful Phase III clinical study with the psoriasis candidate AKP02 and we are looking forward to the study results," says Ola Holmlund, CEO of Lipidor.

"We are pleased to have recently signed an exclusive license agreement with RELIFE, a company in the Menarini Group which has a strong European and global presence. Altogether, this strengthens our quest to make these innovative new drug candidates AKP01 and AKP02 available to psoriasis patients in the hope that they may improve the treatment of their condition and their quality of life."

Lipidor is closely monitoring developments and taking measures to minimize or eliminate the impact on the company’s operations.

Source-Medindia