Successful phase III trial of A 101 45% topical solution to treat common warts.- Aclaris Therapeutics
Aclaris Therapeutics, Inc. announced positive results from its Phase III clinical trial, THWART-2 (WART-302), of A-101 45% Topical Solution (A-101 45% Topical Solution), an investigational new drug for the treatment of common warts (verruca vulgaris).
A-101 45% Topical Solution met the primary and all secondary efficacy endpoints, achieving clinically and statistically significant clearance of common warts. A-101 45% Topical Solution is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts. THWART-2 is one of two randomized double-blind vehicle-controlled Phase III pivotal trials conducted by Aclaris to evaluate A-101 45% Topical Solution as a potential treatment for common warts. Aclaris expects to report data from THWART-1 (WART-301), the second Phase III trial during the fourth quarter of 2019.
Both trials evaluated the efficacy and safety of A-101 45% Topical Solution as compared to placebo (vehicle). The two randomized, double-blind, vehicle-controlled trials were designed to demonstrate the efficacy and safety of A-101 45% Topical Solution for the potential treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years).In the THWART-2 trial 502 subjects who had one to six warts at baseline were randomized and self-administered either A-101 45% Topical Solution or vehicle twice a week over 8 weeks, for a total of 16 treatments. The trial achieved its primary endpoint with a high degree of statistical significance (p<0.0001), i.e. a higher proportion of subjects treated in the a-101 45% topical solution arm versus vehicle had all their identified common warts reported as clear at day 60. warts were assessed using the physician wart assessment scale (pwa="0)" which is a validated four-point scale of the investigators� assessment of the severity of all treated warts.>0.0001),>
In the trial, all secondary efficacy endpoints achieved statistical significance in favor of A-101 45% Topical Solution versus vehicle and are described as follows:Complete clearance of all warts at Day 137 (12 weeks after last treatment) (p=0.0001).Mean per subject percent of treated warts cleared at Day 137 (p<0.0001). clearance in subjects with a single baseline wart at day 60 (p="0.0006)" time to complete clearance of all warts (p><0.0001). there were no treatment-related serious adverse events (saes) in subjects treated with a-101 45% topical solution; however, saes of intestinal obstruction (in the a-101 45% topical solution group) and staghorn renal calculus (vehicle group) were assessed by the investigators as unrelated. treatment-related application site adverse events (aes) were reported in 53.4% and 8.4% of the a-101 45% topical solution and vehicle groups respectively. in the active arm 2% (5 subjects) of application site events were severe (1 pain, and 4 site pallor). the most common aes (occurring in more than 5% of subjects) were application site pain, pallor, erythema, pruritus, scabbing and erosion. no subjects withdrew because of aes.>0.0001).>0.0001).>
Comment: There are no FDA approved prescription treatments for common warts. This treatment is self-administered twice a week for 8 weeks (a total of 16 applications).