Aclaris therapeutics’ announces a-101 45% topical solution meets primary and all secondary efficacy endpoints in second successful pivotal phase 3 clinical trial for the treatment of common warts (thwart-1)
Aclaris therapeutics, inc. announced positive results from its second phase 3 clinical trial, thwart-1 (wart-301), of a-101 45% topical solution (a-101 45%), an investigational new drug, for the potential treatment of common warts (verruca vulgaris). a-101 45% met the primary and all secondary efficacy endpoints, achieving clinically meaningful and statistically significant clearance of common warts. a-101 45% is a proprietary high-concentration hydrogen peroxide topical solution being developed as a potential prescription treatment for common warts. thwart-1 is the second of two phase 3 pivotal trials: thwart-1 and thwart-2 (wart-301 and wart-302, respectively) conducted by aclaris. the two randomized, double-blind, vehicle-controlled trials were designed to evaluate the efficacy and safety of a-101 45% as compared to placebo (vehicle) for the treatment of common warts when applied by subjects (or the parents/guardians of subjects < 18 years). the thwart-1 trial randomized 503 subjects who self-administered either a-101 45% or vehicle twice a week over 8 weeks, for a total of 16 treatments. each subject had one to six common warts at baseline. the trial achieved its primary endpoint with a high degree of statistical significance (p=0.0003), i.e. a higher proportion of subjects treated with a-101 45% versus vehicle had all their identified common warts reported as clear at day 60. warts were assessed using the physician wart assessment™ scale which is a validated four-point scale of the investigators’ assessment of the severity of all treated common warts (pwa=0 means clear). all secondary efficacy endpoints also achieved statistical significance in favor of a-101 45% versus vehicle. in the thwart-1 trial, the two other secondary efficacy endpoints also achieved statistical significance in favor of a-101 45% topical solution versus vehicle and are described as follows: proportion of subjects with a single common wart whose wart is clear at day 60 (p=0.0009); and time for subjects to achieve clearance of all treated common warts (p<0.0001). in thwart-1, there were no treatment-related serious adverse events (saes) in subjects treated with a-101 45%; however, 2 non-related treatment emergent saes were reported (an animal bite in the a-101 45% group and a suicide attempt in the vehicle group). the most common adverse events (aes) occurring in more than 5% of subjects in the a-101 45% group were application site pain, scabbing, erythema, pruritus and erosion. treatment-related aes were reported in 52.8% (34.6% mild, 17.3% moderate and 0.8% severe) and 6% of the subjects in the a-101 45% and vehicle groups, respectively. no subjects withdrew because of aes, but one subject in the a-101 45% group discontinued treatment due to application site erythema and vesicles.
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