AnaptysBio To Discontinue Imsidolimab Development In Moderate-to-Severe Acne

AnaptysBio Inc's ANAB Phase 2 ACORN trial of imsidolimab for moderate-to-severe acne did not demonstrate efficacy over placebo on primary or secondary endpoints.

  • Imsidolimab was generally safe, well-tolerated, and no imsidolimab-related serious or severe adverse events were reported.
  • Based on the results, AnaptysBio will discontinue imsidolimab clinical development in acne.
  • The primary endpoint of facial inflammatory lesion count change from baseline at week 12 was -6.8 (-27%) for the imsidolimab high dose arm, -7.4 (-21%) for the imsidolimab low dose arm, and -9.6 (-38%) for the placebo arm. 
  • Related: AnaptysBio Reveals Updated Imsidolimab Data In Severe Form Of Psoriasis.
  • Enrollment is ongoing in the imsidolimab GEMINI-1 GPP Phase 3 trial and topline data from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa anticipated in H2 of 2022.
  • Beyond imsidolimab, enrollment is ongoing in the AZURE Phase 2 trial of rosnilimab in moderate-to-severe alopecia areata, and Phase 1 topline data for ANB032 is anticipated in Q2 of 2022.
  • AnaptysBio held a cash balance of $615 million at the end of 2021, with an anticipated 2022 net cash burn of $90 million - $100 million.
  • Price Action: ANAB shares closed 13% lower at $24.75 during after-hours trading on Monday.

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