Today Lipidor announced positive results from a Phase I/IIa study investigating the efficacy and tolerability of its AKVANO®/calcipotriol spray formulation for the treatment of psoriasis vulgaris, the most common form of psoriasis. Karolinska Development (STO:KDEV) owns 50% of Lipidor.
"The positive study results represents an important milestone for Lipidor in its efforts to develop a product with equivalent clinical efficacy compared to market leading calcipotriol-only topical treatments, and with superior cosmetic qualities and greater ease of use, thereby, improving compliance rates and patient quality of life", concludes Anders Carlsson, CEO of Lipidor.
Various kinds of ointments, creams and lotions are commonly prescribed treatments for psoriasis, but they also show low compliance rates. This is largely due to their greasiness and inability to absorb into the skin and therefore be present on the skin for a long time after application. This causes personal discomfort as well as staining of clothes.
Lipidor is developing AKVANO®/calcipotriol, a water-free spray formulation containing calcipotriol, a vitamin D derivative that is one of the cornerstones in the treatment of mild to moderate psoriasis vulgaris. The AKVANO® technology enables efficient delivery of the pharmaceutical ingredient. After application the carrier compounds evaporates quickly, leaving a pleasant feeling on the skin and a cosmetically appealing result.
Data from the recently concluded Phase I/IIa clinical study in 24 psoriasis vulgaris patients revealed that the AKVANO®/calcipotriol spray formulation had clear and significant antipsoriatic effects compared to placebo, comparable to a marketed formulation of calcipotriol. This means that the primary objective of the trial was met. In the study, the patients received 10 topical treatments over 12 days. No safety issues were noted in the study.
Approximately 125 million patients suffer from psoriasis worldwide. While the disease varies in its manifestation, psoriasis vulgaris that affects 80-90% of the patients typically causes plaques of rapid skin accumulation at certain areas of the skin. One of the measures of disease severity is the body surface area covered by affected skin plaques or lesions, from distinctly localized to widespread. Psoriasis can cause itching and pain, scaling of skin and bleeding lesions. Quality of life aspects, including self-consciousness and social withdrawal are important factors in the management of the disease including treatment compliance.
Novel molecular signaling pathway found to play a crucial role in maintaining the skin barrier