AnaptysBio Announces British Journal of Dermatology Publication of Imsidolimab (IL-36R) Previously Reported Phase 2 GALLOP Data in Generalized Pustular Psoriasis (GPP) - Seite 2

Imsidolimab was generally well-tolerated. Most treatment-emergent adverse events (TEAEs) were mild to moderate in severity. No patients discontinued the study due to a non-serious TEAE. Two patients experienced serious adverse events (SAEs) that recovered without sequelae. Through Week 16, anti-drug antibodies were detected in one patient, which occurred at Week 12 and did not impact imsidolimab pharmacokinetics, safety or efficacy.

Initial top-line Phase 2 study results were presented at European Academy of Dermatology and Venerology (EADV) Congress in October 2021.

GEMINI Phase 3 Studies

AnaptysBio is conducting two GPP Phase 3 trials for imsidolimab. The first, called GEMINI-1, will enroll approximately 45 moderate-to-severe GPP patients, each experiencing an active flare at baseline, who will be randomized equally to receive either a single dose of 750mg IV imsidolimab, 300mg IV imsidolimab or placebo. The primary endpoint of the Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a GPPPGA score of zero or one at Week 4. Top-line data from an interim analysis of GEMINI-1 is anticipated in the fourth quarter of 2023.

Patients completing the GEMINI-1 trial can subsequently roll over into GEMINI-2, the second Phase 3 trial for imsidolimab in GPP, and will receive monthly doses of 200mg subcutaneous imsidolimab or placebo. The objective of GEMINI-2 is to assess the efficacy, durability of effect, recurrence of flare, and safety of imsidolimab during up to three years of monthly dosing.

The U.S. Food and Drug Administration granted Orphan Drug Designation to imsidolimab for the treatment of GPP in July 2020.

AnaptysBio announced in August 2022 that it intends to complete execution of the GEMINI Phase 3 GPP program and out license imsidolimab prior to potential FDA approval.

About AnaptysBio

AnaptysBio is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics. It is developing immune cell modulators, including two checkpoint agonists in clinical-stage development, for autoimmune and inflammatory disease: rosnilimab, its PD-1 agonist, in a planned Phase 2b trial for the treatment of moderate-to-severe rheumatoid arthritis; and ANB032, its BTLA agonist, in a planned Phase 2b trial for the treatment of moderate-to-severe atopic dermatitis. Its preclinical immune cell modulator portfolio includes ANB033, an anti-CD122 antagonist antibody for the treatment of autoimmune and inflammatory diseases. In addition, AnaptysBio has developed two cytokine antagonists available for out-licensing: imsidolimab, an anti-IL-36R antagonist, in Phase 3 for the treatment of generalized pustular psoriasis, or GPP, and etokimab, an anti-IL-33 antagonist for the treatment of respiratory disorders that is Phase 2/3 ready. AnaptysBio has also discovered multiple therapeutic antibodies licensed to GSK in a financial collaboration for immune-oncology, including an anti-PD-1 antagonist antibody (Jemperli (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) and an anti-LAG-3 antagonist antibody (GSK4074386).