AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP) - Seite 3

An end-of-Phase 2 meeting, based upon data available from the 8 patients enrolled in the GALLOP trial, is anticipated in Q4 2020. In July 2020, the FDA granted orphan drug designation to imsidolimab for the treatment of GPP based upon GALLOP clinical data.

The Company plans to report full data from the GALLOP trial at a medical conference in 2021.

GALLOP Phase 2 Trial Design
Upon review of Day 29 data from the 8 patients enrolled in the GALLOP trial, the Company decided to curtail further enrollment and proceed with preparations for an end-of-Phase 2 meeting with the FDA. Of these 8 patients, which include 3 patients reported in September 2019, 2 patients have completed the 16-week dosing period, 4 patients are anticipated to complete the 16 week dosing period in Q4 2020 and 2 patients have dropped out to date.

Patients were screened among 12 sites located in the United States and Europe. Patients were washed out of prior therapy and no concomitant therapy was permitted during the trial. Rescue therapy was not required by any patients while enrolled in the trial.   Key inclusion criteria include active ongoing GPP disease with a minimum mJDA-SI score of 7 and at least 10% body surface area covered by active pustules and erythema, while key exclusion criteria included concomitant dermatological conditions or infection. Patients were treated with a 750mg intravenous induction dose of imsidolimab at Day 1, followed by monthly 100mg subcutaneous doses on Days 29, 57 and 85. The primary endpoint of this trial was clinical response on the CGI scale on Day 29 and Day 113 without rescue therapy.   Baseline clinical assessments were conducted for each patient on Day 1 prior to imsidolimab dosing. Missing mJDA-SI data points were imputed using last-observation-carry forward (LOCF) methodology.   

In addition to GPP, the Company plans to advance development of imsidolimab in multiple inflammatory indications associated with IL-36 pathway dysregulation. Enrollment has been completed in POPLAR, a randomized, placebo-controlled 50-patient Phase 2 trial of imsidolimab in PPP, and top-line data is anticipated in Q1 2021. The Company also plans, in Q1 2021, to initiate a worldwide patient registry, called RADIANCE, of patients diagnosed with GPP and PPP, which is anticipated to improve understanding of the patient journey and support future clinical trial enrollment. In addition, clinical development of imsidolimab is being expanded into two additional indications, EGFR-mediated skin toxicity and ichthyosis, where Phase 2 trials are expected to be initiated in Q4 2020.