Aclaris Therapeutics to reduce workforce by 46%, provides corporate updates

Aclaris Therapeutics announced several corporate updates. First, Aclaris announced the publication of the Phase 2a trial results of ATI-1777 in moderate to severe atopic dermatitis, or AD, in the peer-reviewed journal JID Innovations on November 27. ATI-1777 is Aclaris’ investigational topical “soft” JAK 1/3 inhibitor being developed as a potential treatment for mild to severe AD that was generated from its proprietary KINect drug discovery platform. The article, entitled “ATI-1777 a topical JAK 1/3 inhibitor may benefit atopic dermatitis without systemic drug exposure, results from preclinical development and Phase 2a randomized-controlled study ATI-1777-AD-201,” presents the results from both preclinical development studies and the Phase 2a study of ATI-1777 in moderate to severe AD, and is available here. In the Phase 2a study, ATI-1777 demonstrated meaningful improvement in the modified Eczema Area and Severity Index, or EASI, over 4 weeks of treatment and minimal measurable systemic exposure with a 2% formulation applied twice daily. Based on these results, Aclaris progressed ATI-1777 into a Phase 2b trial in patients with mild to severe AD. The Phase 2b vehicle-controlled trial is designed to further explore the concentration range of ATI-1777, as well as a once-daily regimen using the 2% formulation. The trial enrolled 250 patients, including adults and children as young as 12 years old, across 34 clinical trial sites in the United States. The primary efficacy endpoint is the percent change in EASI over a period of 4 weeks. Secondary measures of efficacy, as well as safety and pharmacokinetics, will also be assessed. Aclaris now expects to report top-line results from this trial in January 2024. Aclaris also announced the following corporate updates: Aclaris now plans to explore the use of zunsemetinib, its investigational lead oral small molecule MK2 inhibitor, as a potential treatment for pancreatic cancer and metastatic breast cancer as well as in preventing bone loss in patients with metastatic breast cancer. Aclaris plans to use ATI-450 instead of ATI-2231, its second MK2 inhibitor, due to ATI-450’s more advanced clinical development package. Aclaris plans to continue the development in collaboration with Washington University. Aclaris is reassessing the most effective pathway for ATI-2138, its investigational oral covalent ITK/JAK3 inhibitor, including the indication selection due to the evolving competitive landscape within ulcerative colitis. Aclaris plans to provide further guidance in early 2024. Aclaris intends to accelerate the advancement of several of its discovery programs emerging from the KINect drug discovery platform, with the goal of generating investigational new drug applications from these programs in the near term. In addition, Aclaris has approved a plan to reduce its workforce by approximately 46%. Aclaris anticipates this reduction will begin immediately and will be substantially complete by June 30, 2024.