Date: 2013-08-27
Type of information:
phase: 1-2
Announcement: results
Company: Lipidor (Sweden)
Product: Akvano®/calcipotriol spray formulation
Action mechanism:
Disease: psoriasis
Therapeutic area: Autoimmune diseases – Dermatological diseases
Country:
Trial details: The primary objective of the Phase I/IIa clinical trial was met since Akvano®/calcipotriol showed clear and significant antipsoriatic effects, measured by sonography as a reduction in infiltrate thickness, in comparison to corresponding vehicle formulations. A secondary objective was also met since the antipsoriatic effects were comparable to that of the marketed product Daivonex® solution. 24 patients (male and female) were included in the study.
Latest
news: * On August 27, 2013, Lipidor, a drug delivery company focusing on topical treatment, has 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. 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.
