Hansa Biopharma is advancing its clinical pipeline with promising developments for imlifidase, a first-in-class IgG cleaving enzyme. Recent announcements highlight positive results in Guillain-Barré Syndrome (GBS) and the completion of enrollment in a pivotal Phase 3 trial for anti-glomerular basement membrane (anti-GBM) disease.
Positive Phase 2 Results in Guillain-Barré Syndrome
Full results from the 15-HMedIdeS-09 Phase 2 study of imlifidase in GBS demonstrate rapid overall improvement in functional status. Specifically, 37% of patients treated with imlifidase plus IVIg returned to walking independently at one week. An indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) showed patients experienced significantly faster improvement, returning to walking independently six weeks sooner than the IVIg-comparator group.
Phase 3 Enrollment Complete in Anti-GBM Disease
Hansa Biopharma has completed enrollment in the GOOD-IDES-02 trial, a global pivotal Phase 3 trial of imlifidase in anti-GBM disease. Anti-GBM is a rare, severe autoimmune condition affecting approximately 1.6 people per million annually. Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency (EMA).
Imlifidase as Pre-Treatment in Crigler-Najjar Syndrome
In collaboration with Genethon, Hansa Biopharma has initiated a Phase 2 trial of imlifidase as a pre-treatment to GNT-0003 in severe Crigler-Najjar syndrome. This collaboration aims to make gene therapy more effective and accessible to a broader range of patients.
ConfIdeS Trial and BLA Submission
Hansa Biopharma completed recruitment and randomization in its US ConfIdeS trial, a pivotal Phase 3 open-label, randomized, controlled trial of imlifidase in kidney transplantation. Data from the trial is expected to support a Biologic License Application (BLA) submission under the accelerated approval pathway to the US Food and Drug Administration (FDA) in the second half of 2025.
Additional Pipeline Updates
The company also shared positive results from a 12-month follow-up analysis from the NICE-01 trial of HNSA-5487, assessing IgG recovery, immunogenicity and redosing potential. In the analysis, HNSA-5487 reduced IgG levels by more than 95% in a few hours and achieved lower peak anti-drug antibody (ADA) responses confirming its redosing potential. In the first half of 2025, the Company plans to meet with regulatory agencies to establish a clinical pathway focused on neuro-autoimmune disease.
