Hansa Biopharma AB (publ) announced randomization for the US confideS trials expected to conclude in mid 2023. Company plans to submit a Biologics License Application (BLA) under the accelerated approval pathway to the U.S. Food and Drug Administration (FDA) in 2025. To accelerate randomization, Hansa has increased overall site activation up to 25 sites, continued enrollment beyond the targeted 64 patients, and amended the trial protocol to potentially facilitate a broader set of donors for organ allocation.

With this in mind, randomization is taking weeks and even months in most instances. The ConfIdeS trial is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor through the U.S. kidney allocation system. The trial design requires randomization of 64 highly sensitized kidney transplant patients with a cPRA of 99.9%, representing a subset of very highly sensitized patients.

Clinical pipeline update Hansa has made good progress on patient enrollment in two key trials in autoimmune diseases. GOOD-IDES-02: Nine of 50 targeted patients enrolled in this global pivotal phase 3 trial in anti-glomerular basement membrane (anti-GBM) disease. Investigator-initiated trial in ANCA-associated vasculitis: Three of 10 targeted patients enrolled in this single-center, single arm Phase 2 trial 3 Hansa also expects to achieve several milestones by the end of 2023, as previously guided.

17-HMedIdeS-14 (Long-term follow-up study in kidney transplantation) 5-year data read-out: An extended pooled analysis from the 17-HMedIdeS -14 study, a long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase 4; 15-HMedIdeS-09 (Guillain-Barre Syndrome - GBS) results: A phase 2 open-label, single arm, multi-centre, study investigating safety, tolerability, efficacy, pharmacodynamics and pharmacokinetics of imlifidase in patients with GBS, in comparison with matched control patients; 16-HMedIdes-12 (Antibody-Mediated Rejected - AMR) results: A phase 2 randomized, open-label, multi-center, controlled study evaluating safety, tolerability, and efficacy of imlifidase compared to plasma exchange (PE) in removal of donor-specific antibodies (DSAs) in patients experiencing active and chronic active antibody mediated rejection episodes; Sarepta Duchenne Muscular Dystrophy (DMD) pre-treatment Phase 1b: Commencement of a clinical trial evaluating imlifidase as pre-treatment in patients with pre-existing IgG antibodies to delandistrogene moxeparvovec, Sarepta's AAV-based gene therapy for the treatment of DMD Commercial update Total revenue in third quarter (Q3) is SEK 22.8 million, of which is SEK 22.8 billion, of which is SEK 23.8 million, of which was SEK 22.8 million.