Aclaris chops workforce and shifts lead drug’s focus to cancer indications

By cutting programs and 46% of staff, Aclaris becomes the latest company to implement restructuring measures in a bid to free capital.

Justine Ra December 20 2023

Aclaris Therapeutics has made 46% of its workforce redundant to streamline development and retain capital.

The reshuffle, effective immediately, will be “substantially complete” by June 30, 2024. In addition to a reduction in staff, the company will discontinue the development of zunsemetinib (ATI-450) for all immunoinflammatory indications.

Earlier in November, zunsemetinib, an oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor candidate, failed to meet its primary and secondary endpoints in the Phase IIb study (NCT05279417) for moderate to severe rheumatoid arthritis (RA). As a result of this failure, the company decided to cease enrollment for the Phase IIa study for psoriatic arthritis.

This was not the first time the drug failed to meet clinical expectations, as Aclaris reported in March that the drug did not demonstrate significant changes from baseline in nodule and abscess count in the Phase IIa study (NCT05216224) for moderate to severe hidradenitis suppurativa (HS). The study also failed to achieve its secondary endpoint of a 50% reduction on the Hidradenitis Suppurativa Clinical Response (HiSCR-50) scale.

The clinical-stage biopharmaceutical company will continue to evaluate zunsemetinib as a treatment for pancreatic and metastatic breast cancer. As per the press release, zunsemetinib’s more advanced clinical development package makes it a stronger candidate than the company’s other MK2 inhibitor, ATI-2231.

Pipeline updates

Back in October, Aclaris completed enrollment for its Phase IIb (NCT05432596) of ATI-1777, its topical Janus kinase (JAK) 1/3 inhibitor candidate, for the treatment of mild to severe atopic dermatitis (AD). The company anticipates releasing topline results in January 2024. As per CEO Douglas Manion, Aclaris will seek a commercialization partner for ATI-1777, pending positive Phase IIb results.

The company also announced positive Phase I data in September for its oral covalent ITK/JAK3 inhibitor, ATI-2138, and shared additional plans to conduct a Phase IIa proof of concept (POC) study in ulcerative colitis for the drug early in 2024. Plans for a second POC study for another T cell-mediated autoimmune disease were in the books, but the latest press release indicates that the company is now determining the future developmental trajectory for ATI-2138 and will “provide further guidance” in early 2024.

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