Rapid clearance of generalized pustular psoriasis achieved with single imsidolimab dose
Click Here to Manage Email Alerts
Key takeaways:
- 53.3% of 750 mg IV imsidolimab-treated patients achieved the primary endpoint vs. 13.3% of placebo.
- Imsidolimab was well tolerated with no serious adverse events.
The phase 3 GEMINI-1 trial evaluating the safety and efficacy of imsidolimab for the treatment of patients with generalized pustular psoriasis flares met its primary endpoint, AnaptysBio announced in a press release.
“The success of the GEMINI-1 trial highlights Anaptys’ commitment to patients and our ability to internally discover and develop differentiated antibodies,” Daniel Faga, MBA, AnaptysBio president and CEO, said in the release.
Imsidolimab, an IgG4 antibody and interleukin-36 inhibitor, was evaluated in GEMINI-1, a 4-week, double-blind, placebo-controlled, randomized phase 3 trial, for the treatment of generalized pustular psoriasis (GPP) flares.
In the study, 45 patients were randomly assigned to receive a single infusion of 750 mg IV imsidolimab, 300 mg IV imsidolimab or placebo at day 0. The primary endpoint was a proportion of patients achieving GPP-PGA clear or almost clear (0/1) at week 4.
Results showed that 53.3% of the 750 mg group achieved the primary endpoint compared with 13.3% of placebo group (P = .0131). Also, 66.7% of placebo-treated patients left the trial early to enter GEMINI-2 in order to receive a single dose of 750 mg IV imsidolimab as a rescue therapy.
According to the release, imsidolimab was well tolerated with all adverse events being mild or moderate and evenly distributed among treatment arms. There were no infusion reactions, serious adverse events or severe adverse events reported among imsidolimab-treated patients.
Of 30 patients, only one exhibited detectable anti-drug antibodies, which were non-neutralizing.
According to the press release, comprehensive data from GEMINI-1 and GEMINI-2 will be presented at a medical meeting in the second half of 2024. The company also plans to file a biologics license application with the FDA by the third quarter of 2024.
Read more about
Click Here to Manage Email Alerts