Lipidor updates on Phase III study of AKP02 in treatment of psoriasis – half of patients now recruited
On 26 January, Lipidor announced that the first psoriasis patients had been enrolled in the company's Phase III clinical trial of AKP02 cutaneous spray. The observer-blind and placebo-controlled Phase III study included a total of 294 patients. The aim of the study is to show a good therapeutic effect for treatment of mild to moderate psoriasis on both body and scalp. The Phase III study also measures quality of life, and patient satisfaction, to demonstrate the associated benefits of AKP02 that may be significant for future commercialization. The trial is fully funded with existing cash and is conducted by Cadila Pharmaceuticals, which successfully completed the Phase III study with its predecessor AKP01.
With the current patient recruitment rate, the last patient is expected to commence treatment in June and topline results from the Phase III study with AKP02 are expected in the third quarter of 2022. Lipidor and the company's commercial partner RELIFE, a company in the Menarini group, are already working together to ensure that the two topical drug candidates, AKP01 and AKP02, become available for treatment for mild to moderate psoriasis in Europe, the CIS countries and Turkey. Conditions for new commercial agreements are continuously investigated and there is great interest from the market.
The psoriasis candidate AKP02 combines calcipotriol and betamethasone dipropionate and is based on Lipidor's patented AKVANO® technology. Lipidor has elected to compare the sprayable drug candidate AKP02 with Enstilar, which is a commonly prescribed foam preparation for topical treatment of psoriasis. AKP02 contains the same combination of active substances as Enstilar.
Positive results from the Phase III study with Lipidor's drug candidate AKP01, which is based on calcipotriol alone, show that AKVANO® technology works well for drugs for treatment of psoriasis. The preclinical studies with AKP02 also show promising results. The goal of AKP02 is to offer a patient-friendly, spray-based treatment for mild to moderate psoriasis.
“It’s gratifying to see that participating clinics in the Phase III study are recruiting patients at a good pace,” says Ola Holmlund, Lipidor CEO. “We look forward to presenting results from the study during the third quarter of 2022."
The information was provided for publication by Lipidor’s CEO on 20 May 2022 at 8.30am CEST.
For more information, please contact:
Ola Holmlund, CEO
Telephone: +46 (0)72 50 70 369
Erik Penser Bank AB
Telephone: +46 (0)8 463 80 00
About Lipidor AB
Lipidor AB (www.lipidor.se) is a Swedish, Stockholm-based research and development company with a pipeline of pharmaceutical development projects in preclinical and clinical phases. The Company develops topical medical products for the treatment of diseases such as psoriasis, acne vulgaris, bacterial skin infections and atopic dermatitis by reformulation of proven pharmaceutical substances.