Micro-cap biotech Aclaris Therapeutics Inc ACRS's market cap was growing by more than 50% Tuesday morning.
What Happened
Aclaris, a biopharma company focusing on immune-inflammatory and dermatological diseases, announced positive results from a Phase 3 THWART-2 study that is evaluating the A-101 45% topical solution as an investigational new drug for the treatment of common warts.
A-101 met the primary endpoint and all secondary endpoints, achieving clinically and statistically significant clearance of common warts, the company said.
A-101 is a proprietary high-concentration hydrogen peroxide topical solution.
The THWART-2 trial studied 502 subjects with one to six warts at the baseline who were randomized and self-administered either A-101 or a placebo twice a week over eight weeks.
The study met the primary endpoint, with a higher proportion of the subjects in the treatment arm having all their identified warts reported as clear at day 60.
No treatment-related serious adverse events, or SAEs, occurred that were related to A-101 administration, Aclaris said.
Investigators did report SAEs of intestinal obstruction and staghorn renal calculus, which the company dismissed as unrelated.
Why It's Important
No FDA-approved prescription treatments exist for common warts.
Common warts, caused by a virus infecting the top layer of the skin, affect an estimated 22 million Americans each year, with children more prone to the condition than adults.
"This treatment is self-administered twice a week for eight weeks (a total of 16 applications) and we believe these results will be of interest to partners seeking to commercialize A-101 45% topical solution," Aclaris CEO Neal Walker said in a statement.
THWART-2 is one of the two pivotal Phase 3 trials being conducted by the company that are evaluating the safety and efficacy of A-101, which would support an NDA filing.
The company said it expects to report the results of the second pivotal Phase 3 study in the fourth quarter of 2019.
In early September, Aclaris announced new strategic direction following a review, with the company deciding to actively explore strategic alternatives for commercial assets, alopecia and wart development assets.
Aclaris shares were trading higher by 57.72% at $1.73 at the time of publication on about 12 times their average volume.
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