Aclaris Therapeutics Provides R&D Update

Aclaris Therapeutics

WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS) has provided an update on the status of certain of its clinical programs and on its research and development (R&D) operations.

Clinical Program Update:

  • Zunsemetinib, an Investigational Oral MK2 Inhibitor
    • Aclaris initiated study activities and began activating sites in December 2021 in the following two studies:
      • ATI-450-RA-202: Phase 2b clinical trial of zunsemetinib in subjects with moderate to severe rheumatoid arthritis (RA). This is Aclaris’ second Phase 2 clinical trial of zunsemetinib in subjects with moderate to severe RA, and is primarily designed to assess the efficacy of multiple doses of zunsemetinib to aid in the selection of an optimal dose to progress in future development.
      • ATI-450-HS-201: Phase 2a clinical trial of zunsemetinib in subjects with moderate to severe hidradenitis suppurative (HS).
  • ATI-2138-PKPD-101: Aclaris completed dosing of the first cohort of subjects in its Phase 1 single ascending dose clinical trial of ATI-2138, its investigational oral ITK/TXK/JAK3 inhibitor, in healthy subjects, in December 2021. This is Aclaris’ first-in-human trial of ATI-2138, and is designed to assess the safety and tolerability of ATI-2138 in healthy subjects and provide dosing guidance for future clinical trials.
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R&D Operations Update:

  • David Gordon, Aclaris’ Chief Medical Officer, left the Company effective January 7, 2022.
  • Aclaris has bolstered its R&D group, including in the areas of clinical, preclinical and discovery, quality, pharmacology, and regulatory.
  • As Aclaris continues to grow and evolve, the Company plans to hire several key leadership positions over the coming months to support the operational plans and strategic direction of the Company.

“We are very excited to start the new year with the commencement of three clinical trials,” said Dr. Neal Walker, President and CEO of Aclaris. “Our clinical data to date demonstrate the potential for zunsemetinib to be a new oral approach for the treatment of RA, and we hope to further this finding in the Phase 2 trials, including in additional indications, and support our hypothesis that MK2 inhibition is an important novel target for the treatment of immuno-inflammatory diseases. The commencement of our first-in-human trial of ATI-2138 is also an important first step in the clinical development of ATI-2138. In addition, as we expand and develop our pipeline, we have and continue to strengthen the breadth and expertise of our R&D group to meet our needs. Lastly, we would like to thank Dave for his contributions to Aclaris and we wish him the best in his future endeavors.”

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