AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP)
SAN DIEGO, Oct. 13, 2020 (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 positive topline data from an interim analysis of its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe generalized pustular psoriasis (GPP), also known as the GALLOP trial. GPP is a chronic, life-threatening, rare inflammatory disease with no approved therapies.
“We are encouraged by the rapid onset, overall safety and promising efficacy profile demonstrated to date by imsidolimab for the treatment of patients suffering with GPP,” said Paul F. Lizzul, chief medical officer of AnaptysBio. “We look forward to engaging with regulatory authorities to progress imsidolimab into Phase 3, and in doing so offer a potential therapeutic intervention for these patients with high unmet medical need.”
“GPP is a life-threatening disease that seriously debilitates patient lives with no approved therapies,” said Johann Gudjonsson, Associate Professor of Dermatology, University of Michigan. “The efficacy and safety demonstrated in this trial further validates the potential for IL-36 receptor inhibition in helping GPP patients. I look forward to advancement of imsidolimab for the treatment of GPP and for other inflammatory conditions where this target and pathway may play an important role.”
Table 1. Key endpoints at Day 8 and Day 29 relative to baseline.
Imsidolimab was generally well-tolerated and most treatment-emergent adverse events were mild to moderate in severity and resolved without sequelae. No infusion or injection site reactions were observed. One patient dropped out of the trial due to a diagnosis of Staphylococcal aureus bacteremia in the first week, which was a serious adverse event deemed to be possibly drug-related. Because the patient was symptomatic prior to dosing and had a prior medical history of bacteremia, a common comorbidity of GPP, the Company does not believe this event is likely attributable to imsidolimab. Another patient dropped out of the study on Day 22 due to investigator reported inadequate efficacy. One patient contracted COVID-19 during the course of the trial, which was mild, unrelated to imsidolimab, and did not lead to study discontinuation.
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
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.