Aclaris Therapeutics Announces Positive Phase 1b Proof-of-Concept Primary Analysis Results for its Anti-TSLP/IL-4Rα Bispecific ATI-052 in Atopic Dermatitis (AD) and Asthma

Neal Walker, Chief Executive Officer of Aclaris

“These strong results convey ‘the art of the possible’ with this bispecific mechanism in heterogeneous diseases across diverse patient populations and support that this is a potent, broadly acting compound with potential best-in-class activity”

Neal Walker, Chief Executive Officer of Aclaris

“Across heterogeneous patient populations, we observed breadth and depth of response, normalization of the immune proteome, encouraging early durability, evidence of potential synergy of targets, and a favorable safety profile associated with ATI-052 – all of which clarify its potential across indications. Consistent with our development strategy, we intend to prioritize initiating a Phase 2b trial in EoE early next year and provide an update on plans for a potential additional indication in the near term.”

Michael Cameron, M.D., FAAD, CEO of Equity Medical and Assistant Clinical Professor, Department of Dermatology at Mount Sinai in New York, and investigator in the trial

“These ATI-052 data in AD are very noteworthy, not only in strength of response at day 57 but also in rapidity and durability of response”

Michael Cameron, M.D., FAAD, CEO of Equity Medical and Assistant Clinical Professor, Department of Dermatology at Mount Sinai in New York, and investigator in the trial

“Given the mechanism of ATI-052, one would expect reductions in EASI and itch from baseline to be rapid and sustained due to blockade of IL-4 and IL-13 via their shared receptor IL-4Rα, and durable through blockade of the TSLP alarmin. This is consistent with my experience during the trial. For example, one of my longstanding refractory patients responded quickly to ATI-052 and had a durable response that lasted months beyond their last dose. This bodes well for the mechanism in future clinical trials.”

Emma Guttman, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City

“These ATI-052 pharmacodynamic biomarker results in patients with AD are clear, and significantly correlated to the efficacy results.”

Emma Guttman, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City

“Among the most important findings were the overall improvements to the immune proteome in patients receiving ATI-052; key immune proteins were significantly downregulated by ATI-052 compared to placebo, potentially highlighting the contribution of added benefit of blocking TSLP in this indication, with the proteomic phenotype of lesional skin closely resembling that of non-lesional skin already at week 8. These results, including ATI-052’s ability to modulate all three T helper cell related markers, are suggestive of early potent anti-inflammatory clinical activity.”

Chris Brightling, Clinical Professor in Respiratory Medicine at the University of Leicester and Deputy Director and Respiratory and Infection Theme Lead, NIHR Biomedical Research Centre: Leicester

“In such a Phase 1b trial, the goals are to ensure safety and to develop some encouraging signals; in this case, the results are significantly better than encouraging”

Chris Brightling, Clinical Professor in Respiratory Medicine at the University of Leicester and Deputy Director and Respiratory and Infection Theme Lead, NIHR Biomedical Research Centre: Leicester

“Of particular interest are the rapid improvements in the breath biomarker FeNO, both in the overall population and when stratified by baseline eosinophils, and the lung function test FEV1, with maximum effects that are at least as good if not improving on those seen by comparator compounds.”