Anaptys Announces Positive Top-Line GEMINI-2 Phase 3 Clinical Trial Results of Imsidolimab (IL-36R) in Generalized Pustular Psoriasis (GPP) - Seite 2

“The success of the GEMINI-1 and GEMINI-2 Phase 3 trials highlights Anaptys’ ability to internally discover and develop differentiated antibodies that deliver meaningful outcomes for patients,” said Daniel Faga, president and chief executive officer of Anaptys. “The results of these modestly sized studies reinforce that only one single IV dose of imsidolimab was required to achieve rapid clearance of GPP through four weeks and maintained in patients receiving a monthly SC maintenance dose. We remain intent on out-licensing imsidolimab to bring this therapy to patients living with this highly morbid condition.”

Imsidolimab Well Tolerated Through End of Study

Data from both trials demonstrate a consistent, favorable safety and tolerability profile with no treatment-related serious adverse events (SAEs) or SAEs leading to discontinuation reported in imsidolimab-treated patients.

Additionally, the data show:

• Low incidence and no elevation of infections versus placebo
• No cases reported of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or Guillain-Barre syndrome (GBS)
• No infusion reactions reported
• Overall incidence of anti-drug antibodies (ADA) was low and, when detected, determined to be non-neutralizing

Next Steps with GEMINI-1 and GEMINI-2 Trials

Anaptys plans to submit a comprehensive data abstract for GEMINI-1 and GEMINI-2 results to a H2 2024 medical meeting.

With all patients having passed 24 weeks and the furthest patient being treated through 92 weeks, the company is concluding the GEMINI-2 trial. The company plans to out-license imsidolimab in 2024, and a potential future filing of a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) will be contingent on an out-licensing transaction.

“We’re immensely grateful to all the study investigators, study staff and trial participants who helped evaluate this potential new treatment option for GPP,” said Paul Lizzul, M.D., Ph.D., chief medical officer of Anaptys. “We’re pleased that we have generated clinically meaningful data to support a potential future regulatory submission.”

GEMINI-1 and GEMINI-2 Trial Designs

Anaptys’ first Phase 3 GEMINI-1 clinical trial was a four week, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of imsidolimab in patients with GPP, irrespective of mutational status. A total of 45 patients, 15 patients per arm, were enrolled across diverse global regions ranging from the U.S., EU, MENA, and Asia. Patients were randomized 1:1:1 to receive a single infusion of 750mg IV imsidolimab, 300mg IV imsidolimab or placebo at Day 0.