Aclaris Therapeutics (NASDAQ:ACRS) executives outlined a busy clinical calendar for the biotechnology company during a fireside chat at the Jefferies 2026 Global Healthcare Conference, highlighting upcoming readouts across its immunology pipeline and a planned Phase 2 asthma study for its lead bispecific antibody.
Neal Walker, Aclaris’ chief executive officer, said the company is focused on both large- and small-molecule therapeutics and currently has three clinical-stage assets, with another expected to move toward an investigational new drug application in the second half of the year.
ATI-052 Seen as Key Near-Term Focus
Much of the discussion centered on ATI-052, which Walker described as targeting IL-4R and TSLP, the same three inflammatory mediators implicated by Pfizer’s trispecific approach in atopic dermatitis: IL-4, IL-13 and TSLP. Walker said Pfizer’s data were the most relevant read-through for Aclaris because IL-4R inhibition blocks both IL-4 and IL-13 signaling.
“We think it makes sense to continue to pursue that in AD, and we’re looking forward to reporting out on our Phase 1b data,” Walker said.
Hugh Davis, Aclaris’ president, said prior healthy volunteer single- and multiple-ascending-dose data showed favorable pharmacokinetics, including duration that could support dosing as infrequently as every three months. He said the company observed complete inhibition of either TSLP- or IL-4-activated TARC secretion in its pharmacodynamic assays.
Davis also said the company saw “very low incidence and very low titer” of anti-drug antibodies in healthy volunteers, with no impact on clearance. He added that ATI-052’s half-life was “greater than three times that of Dupixent.”
Roland Kolbeck, Aclaris’ chief scientific officer, said the company’s pharmacodynamic assay used cytokine concentrations far above those typically seen in disease, adding that Aclaris feels “really, really comfortable” with the results generated.
Phase 2 Asthma Study Planned for Fourth Quarter
Walker said Aclaris has already decided to move ATI-052 into a Phase 2 asthma study, with the trial expected to start in the fourth quarter. He said the decision is based on internal data and the existing validation of both Dupixent and Tezepelumab in asthma.
“All we’re simply saying is we’ve got the ability to target both molecules within the same construct,” Walker said. “From our perspective, that doesn’t take a lot of thinking about.”
The planned Phase 2 asthma study will follow the company’s Phase 1b readouts, which Walker said are expected in the early part of the second half of the year.
Kolbeck said the asthma Phase 1b study is a 16-patient, single-dose trial in moderate asthmatics with high type 2 inflammatory markers, including FeNO above 35 parts per billion and circulating eosinophils above 150. The company will assess FeNO reduction, eosinophil reduction and FEV1 improvement, with an expectation of seeing effects similar to or better than Dupixent within the study’s short time frame.
Atopic Dermatitis Readout to Guide Next Steps
Walker said the atopic dermatitis Phase 1b study is placebo-controlled and designed to look for signs of additive or synergistic benefit. He said the company would like to see directionality showing ATI-052 performs better than Dupixent, with a 5% improvement across efficacy measures representing added upside and a 10% improvement representing a “home run scenario.”
If the company sees even its base-case result, Walker said Aclaris would move forward in atopic dermatitis. Davis said a future study would likely include three active dose arms and placebo, with the Phase 1b data helping determine dose and dosing interval.
TSLP Monoclonal Antibody Could Be Partnering Candidate
Aclaris is also studying a TSLP monoclonal antibody in atopic dermatitis, with data expected after the ATI-052 Phase 1b readouts. Walker said the company would want to see statistically significant results and efficacy on par with Dupixent to justify further development.
However, he said ATI-052 could “necessarily cannibalize” the TSLP monoclonal antibody if it continues to produce the expected data, and Aclaris expects to “over-index” spending on the bispecific going forward. Walker suggested the TSLP monoclonal antibody could be better advanced in a partner’s hands if the data are strong.
Walker also referenced Aclaris’ China partner, which is conducting Phase 3 studies in asthma and chronic rhinosinusitis with nasal polyps, as well as a Phase 2 COPD study. He said those studies may read out in late 2027 or 2028, and that everything Aclaris has seen to date has been “quite encouraging.”
Small-Molecule Franchise Remains Part of Strategy
Walker described ATI-2138 as a broad inhibitor hitting ITK, TXK and JAK3, calling it “a pretty large hammer.” Aclaris used atopic dermatitis as a proof-of-concept indication but now plans to study the drug in lichen planus, where Walker said the mechanism is a strong fit because of the disease’s antigenic stimulation through the T-cell receptor.
Walker said lichen planus includes mucosal, cutaneous and hair follicle-related phenotypes, with no approved therapies. He said Aclaris is in discussions with regulators on the appropriate path and expects there may be ways to expedite development.
Looking ahead, Walker said the company views ATI-052 and its next-generation ITK inhibitor as the two “game-changer” molecules in its portfolio. He said Aclaris had $191 million on its balance sheet and is fully funded through the end of 2028, including the planned Phase 2 asthma study for ATI-052.
About Aclaris Therapeutics (NASDAQ:ACRS)
Aclaris Therapeutics, Inc (NASDAQ:ACRS) is a clinical‐stage biopharmaceutical company focused on discovering, developing and commercializing novel small‐molecule therapies for dermatologic diseases and related rare disorders. The company’s pipeline includes several product candidates designed to address chronic inflammatory skin conditions and non‐melanoma skin lesions. Lead programs include ATI‐50002, a topical agent in late‐stage development for molluscum contagiosum removal; ATI‐50003 for common wart resolution; ATI‐1501, an oral JAK1/2 inhibitor targeting pruritic disorders; and ATI‐450, an oral MK2 inhibitor for inflammatory indications.
Founded in 2016 and headquartered in Malvern, Pennsylvania, Aclaris leverages proprietary chemistry platforms and translational research capabilities to advance multiple clinical and preclinical candidates.
