AnaptysBio Reports Imsidolimab ACORN Phase 2 Clinical Trial Data in Moderate-to-Severe Acne

• Imsidolimab (anti-IL-36R Ab) treatment did not demonstrate improvement over placebo in top-line primary or secondary endpoints
• AnaptysBio to discontinue imsidolimab clinical development in acne
• Imsidolimab was generally safe, well tolerated and no imsidolimab-related serious or severe adverse events were reported
• Enrollment ongoing in imsidolimab GEMINI-1 GPP Phase 3 trial and top-line data from HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa anticipated in H2 2022
• Rosnilimab (anti-PD-1 agonist Ab) AZURE Phase 2 moderate-to-severe alopecia areata enrollment ongoing and ANB032 (anti-BTLA modulator Ab) Phase 1 healthy volunteer top-line data anticipated in Q2 2022
• Continue to operate in a capital-efficient manner with approximately $615 million in cash at end 2021 and anticipated 2022 net cash burn of $90 to $100 million

SAN DIEGO, March 14, 2022 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe acne, also known as the ACORN trial, did not demonstrate efficacy over placebo on primary or secondary endpoints.  

AnaptysBio continues to advance three wholly-owned pipeline programs through clinical development. While clinical development is being discontinued in acne, imsidolimab demonstrated efficacy and safety in the GALLOP Phase 2 trial in generalized pustular psoriasis (GPP) and enrollment of the GEMINI-1 GPP Phase 3 trial is ongoing and top-line data from the imsidolimab HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa is anticipated during the second half of 2022. Beyond imsidolimab, enrollment is ongoing in the AZURE Phase 2 trial of rosnilimab, a PD-1 agonist antibody, in moderate-to-severe alopecia areata and healthy volunteer Phase 1 top-line data for ANB032, a BTLA modulator antibody, is anticipated in the second quarter of 2022.

“Although the results of this ACORN trial are disappointing, I would like to thank all of the patients, investigators, staff and our employees involved in conducting this trial,” said Hamza Suria, AnaptysBio’s president and chief executive officer. “We look forward to further advancement of imsidolimab for the treatment of GPP and hidradenitis suppurativa. AnaptysBio continues to utilize its strong cash position in a capital-efficient manner to advance three wholly-owned clinical-stage programs with $90 to $100 million anticipated net cash burn in 2022.”