Warts for the win: Aclaris' lead drug clears pivotal study
Aclaris Therapeutics has found a way to get rid of the warts and all.
The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.
The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study. Each secondary endpoint also emerged in favor of A-101, the company said.
Shares of the Wayne, Pennsylvania-based company $ACRS soared about 65.5% to $1.82 in premarket trading on Friday.
Another late-stage trial in common warts is ongoing, and data are expected in the fourth quarter.
“Given no FDA approved treatments for common warts, which impacts 22M Americans each year, it seems that there would be a relatively ‘low bar’ for A-101 45% to receive approval, assuming the confirmatory Ph3 THWART-1 data also reads out positively,” Jefferies analysts wrote in a note.
“With only topline information, it is difficult to compare to the prior A-101 Ph2 datasets as well as VRCA’s recently reported Ph2 data for VP-102 in treating common warts.”
Verrica Pharmaceuticals $VRCA earlier this year disclosed positive data from an open-label mid-stage study testing its drug, VP-102, in patients with up to six warts. Data skewed in favor of VP-102 on the primary endpoint of complete clearance of all treatable warts at day 84, as well as the secondary goal of the percentage reduction of warts. The topical therapy comprises a solution of 0.7% cantharidin — a blister-inducing agent secreted by certain beetles — which was historically used as an aphrodisiac. Topical cantharidin has been used on warts and molluscum since the 1950s, although the chemical lost FDA approval in 1962 after manufacturers failed to furnish adequate evidence supporting its efficacy.
Weeks ago, Aclaris concluded a strategic review of its business — resolving to focus its resources on its immuno-inflammatory pipeline (encompassing ATI-450, ATI-1777 and other preclinical drug candidates). It is now looking for partners on its commercial business: Rosacea treatment Rhophade and seborrheic keratoses therapy Eskata. In addition, the company is also seeking partners for a trifecta of therapies in development — experimental warts drug A-101, as well as the investigational alopecia treatments ATI-501 (oral) and ATI-502 (topical).
As a result, the company announced 86 layoffs. The restructuring is expected to keep the lights on until the third quarter of 2021.
“While we hold the mgt team in high regard as thought leaders in dermatology, the company has executed poorly over the past year (e.g., botched Eskata launch, mixed clinical data for the JAK alopecia programs)…” Jefferies analysts said in a note dated September 6.
In June, the company suffered a setback after a mid-stage study testing ATI-502 failed to improve scalp hair coverage, which crushed its stock. Aclaris paid Rigel Pharma $8 million upfront in 2017 for global licenses to both ATI-501 and ATI-502.
The disclosure came days after the FDA reprimanded the company for making “false or misleading claims” in a promotional video for Eskata.
“That said, we see value in the current capitalization. Looking ahead, with a sub $40M market value (trading at ~0.45x net cash), ACRS shares could rebound if mgt can execute on its revamped strategy,” the analysts added.
