Hansa provides update on Pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease

Lund, Sweden, 16 December 2025. Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA), today announced that GOOD-IDES-02, a global pivotal Phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease, did not meet its primary endpoint. The endpoint was renal function at 6 months, evaluated by estimated glomerular filtration rate (eGFR).

Approximately 60% of patients treated with imlifidase followed by the standard of care (SoC) protocol defined in the trial did not require dialysis at 6 months, which represented a substantial improvement and clinical benefit compared to what has been observed in historical control cohorts. Outcomes generally observed in these patients reflect only 20-25% who do not require dialysis at 6 months, which also was the basis for powering the trial.  However, the treatment response was similar in patients in the control arm treated with the defined SoC alone.

In the trial, SoC was defined as immediate and intense plasma exchange (PLEX) together with cyclophosphamide (CYC) and glucocorticoids. 

The administration of imlifidase in combination with SoC proved to be well tolerated with an acceptable safety profile, in keeping with what has been observed in other imlifidase clinical trials.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said “We are disappointed not to be able to provide a new treatment option for this patient group, who to date have experienced poor outcomes. Despite the deep and rapid reduction of anti-GBM antibodies following imlifidase treatment, it did not result in a statistically significant outcome in this setting. We are, however, delighted to see the overall very strong results where approximately 60% of patients did not require dialysis at 6 months, which is almost three-fold that of typically reported outcomes for this disease. I want to thank the patients, investigators and care givers who participated in the trial.”  She added: “We remain very excited by imlifidase’ consistent effect, potential in the gene therapy area and that we are on track to file our BLA with the FDA, related to desensitization of highly sensitized patients on the waitlist for kidney transplant, before the year end.”

Professor Mårten Segelmark, International Coordinating Investigator in GOOD-IDES-02 said ”Although the trial did not meet the primary endpoint, the overall outcome, in terms of avoiding dialysis dependency, is encouraging as it shows that anti-GBM patients clearly benefit from receiving a more aggressive treatment compared to what has previously been achieved in clinical practice.”

A total of 50 adult patients were enrolled in the trial, with 25 randomized to receive imlifidase in combination with SoC and 25 receiving SoC treatment only.

GOOD-IDES-02 (Trial ID: 21-HMedIdeS-24) is an open label, multi-centre Phase 3 trial involving over 50 sites in 14 countries in the EU, US and the UK. The primary objective of the study was to assess the effect on kidney function of imlifidase in combination with SoC versus SoC alone in the treatment of patients with severe anti-GBM disease. The primary and key secondary endpoints were assessed at 6 months through the evaluation of renal function as measured by estimated glomerular filtration rate (eGFR) and need for dialysis. Other outcomes include effects of treatment on anti-GBM antibody and ANCA levels, other measures of kidney function, health-related quality of life and safety. Patients continue to be followed up until 24 months after randomisation; long-term outcomes will be reported separately.

More information about the trial is available at ClinicalTrials.gov under NCT05679401.

This is information that Hansa Biopharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 23:07 CET on December 16, 2026.