Lipidor Announces Enrolment of Last Patient in Calcipotriol/AKVANO spray (AKP01) Phase III Study Targeting Psoriasis
Lipidor AB (publ) today reports that the last patient has been enrolled in the ongoing phase III study using calcipotriol spray against mild to moderate psoriasis. Results from the study are expected to be presented in December 2019.
Lipidor has developed a sprayable calcipotriol product, Calcipotriol/AKVANO 50 µg/g cutaneous solution (AKP01), formulated with the company’s lipid-based technology, providing more precise dosing and increased comfort to patients.
“We are pleased to see that the study follows the time plan and that all patients now are included,” says Lipidor CEO Ola Holmlund. “Our objective is to present results already before the end of the year. We are grateful for the participation of the involved clinics and patients for making this study possible.”
The phase III study is a comparative, randomized and placebo-controlled study with 277 patients treated at 14 clinics across India over a period of 8 weeks. The study compares the therapeutic equivalence of the calcipotriol spray with a marketed calcipotriol ointment.
The study is implemented in collaboration with Cerbios-Pharma SA, specialized in the development and manufacturing of chemical and biological APIs, and Cadila Pharmaceuticals Ltd of India, which is responsible for the study. Cadila Pharma is carrying out the clinical phase III trial at 14 centers in India and has recruited 277 patients having mild to moderate psoriasis.
“As we conclude this clinical study in India, we are close to our goal of coming up with a novel solution for patients suffering from Psoriasis ensuring high efficacy and more convenience, through our partnership with Lipidor.” says Cadila Pharma’s CMD, Dr. Rajiv Modi. “This ties into our vision of providing innovative and affordable solutions to our patients.”
Psoriasis is a chronic disease in which the immune system plays a central part. The disease affects between 2 and 3 percent of the world’s population.
This information above was provided by Lipidor according to EU Market Abuse Regulations. The information was provided, through the below contact person, for publication on 9 September 2019 at 13.45 (CET).
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