Aclaris hammered as hair loss drug flops in PhII, days after FDA took issue with Eskata ads
The topical treatment for alopecia areata that Aclaris Therapeutics licensed from Rigel Pharma has failed a mid-stage study for alopecia areata, leaving the company with a drug that seems to have caused no harm but no benefit either.
While execs vowed to find a possible way forward with subgroup analysis, the results didn’t leave much room for hope. Neither the 0.46% or 0.12% concentrations of ATI-502 proved superior to placebo in improving scalp hair coverage — at least not in a statistically significant way. In fact, an unexpectedly effective vehicle outperformed the lower dose on several endpoints, which were alternative measurements of hair loss severity.
“We are surprised and extremely disappointed by the results of this Phase 2 trial,” president and CEO Neal Walker said in a statement.
So were investors. Aclaris’ stock $ACRS has tumbled 32.58% since the announcement Wednesday at market close and now sits at $3.00.
It continues a downward trajectory triggered by the FDA’s request for Aclaris to pull a promotional video on a different treatment several days ago, stating that the ad “makes false or misleading claims” regarding their hydrogen peroxide topical solution, Eskata, for raised seborrheic keratoses.
Aclaris is now pinning its hopes on the upcoming Phase II readout of ATI-501, an oral JAK1/JAK3 inhibitor that goes after the same disease. The basic mechanism remains the same — stopping T cells from launching an attack on follicle cells — but the hope is it will work for more severe patients.
Both ATI-501 and ATI-502 were subjects of a 2017 license agreement, where Aclaris paid Rigel $8 million upfront for worldwide rights.
“From a hair loss perspective we still remain focused on the category broadly and look forward to the results of the oral work later this year,” a subdued Walker told an analyst on a conference call.
While the biotech also counts a “soft topical” JAK in its arsenal — obtained from a $20 million buyout of St. Louis-based Confluence Life Sciences — Walker said they are more interested in deploying it for other types of hair loss as well as atopic dermatitis.
Aclaris is also testing ATI-502 for vitiligo, androgenetic alopecia and atopic dermatitis while awaiting Phase III results for A-101, a topical therapy for common warts.
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