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Lipidor to begin Phase III trial on psoriasis treatment

pharmafile | April 22, 2021 | News story | |  Phase III trials, lipidor, pharma, pharma news, psoriasis 

Lipidor has submitted an application with the Indian Medical Products Agency to begin a Phase III trial on their drug candidate AKP02, for patients with mild to moderate psoriasis.

AKP02 combines calcipotriol and betamethasone and is based on Lipidor’s AKVANO technology. The treatment aims to offer a patient-friendly, spray-based treatment for mild to moderate plaque psoriasis.

Previous positive results from the Phase III trial of the medicine’s predecessor AKP01, based solely on calcipotriol, show that Lipidor’s AKVANO technology works well for the treatment of psoriasis. The company’s preclinical studies have also shown that betamethasone works well in AKVANO.

AKP02’s Phase III study, involving 294 patients, will hope to demonstrate good therapeutic efficacy for the treatment of mild to moderate plaque psoriasis on both the body and scalp. It will be compared to Enstilar, a commonly prescribed therapy in foam form for topical treatment of this type of psoriasis. 

The study, which will be run by Cadila Pharmaceuticals, 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 this summer, with reporting in the first half of next year.

125 million people worldwide are thought to suffer from psoriasis, a skin disease that causes itchy patches on the body. Psoriasis is a long-term disease without a cure.

Ola Holmlund, CEO of Lipidor, said: ”The experience from AKP01 means that we also have high hopes for a successful study with our other psoriasis candidate, AKP02. It is gratifying that the market has shown a great interest in AKP02, and by financing the implementation of the Phase III study, Lipidor retains a larger upside of any outlicensing.

“We continue to see great potential in our first drug candidate AKP01 and we consider the opportunity to outlicense AKP01 and AKP02 in a single package to be an advantage for the licensee in registration, manufacture and commercialisation.”

Jack Goddard

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