Imsidolimab Development for HS Discontinued

AnaptysBio will refocus R&D efforts on its immune cell modulator pipeline.

AnaptysBio Inc discontinued the clinical development of imsidolimab for the treatment of moderate-to-severe hidradenitis suppurativa (HS).1 The anti-IL-36 receptor antagonist was safe and well-tolerated, but it did not show improvement over the placebo in the primary and key secondary endpoints of the HARP phase 2 trial. No significant adverse events were reported.

Previously, imsidolimab indicated positive efficacy and safety results in the GALLOP phase 2 trial for generalized pustular psoriasis (GPP), a life-threatening inflammatory disease in which imsidolimab has been granted Orphan Disease Designation. According to AnaptysBio, enrollment of the GEMINI-1 GPP phase 3 registrational trial is ongoing and top-line data is expected in Q4 2023. AnaptysBio plans to out-license investigational imsidolimab before the potential FDA approval for the treatment of GPP.

The double-blind, placebo-controlled HARP phase 2 trial enrolled 149 patients with moderate-to-severe hidradenitis suppurativa across North America and Europe. Key inclusion criteria included patients aged 18 to 75 years old, clinically confirmed ongoing moderate-to-severe HS with at least 5 inflammatory nodule and abscess (AN) lesion count, less than 20 draining fistulas, and at least Hurley stage 2. The primary endpoint was mean change in AN lesion count from baseline at week 16.

AnaptysBio will continue its development of 2 immune cell modulators targeting PD-1 and BTLA for autoimmune and inflammatory diseases.2 Top-line data from AZURE phase 2 trial of rosnilimab, a PD-1 agonist antibody, for moderate-to-severe alopecia areata is expected in Q1 2022.

References:

  1. AnaptysBio reports HARP phase 2 top-line data of imsidolimab in moderate-to-severe hidradenitis suppurativa. AnaptysBio. Published August 3,1 2022. Accessed September 1, 2022. https://ir.anaptysbio.com/news-releases/news-release-details/anaptysbio-reports-harp-phase-2-top-line-data-imsidolimab
  2. Pipeline. AnaptysBio. Accessed September 1, 2022. https://www.anaptysbio.com/pipeline/overview/