Update on ConfIdeS Phase 3 trial of imlifidase in highly sensitized kidney transplant patients

Biologic License Application submission expected for 2025 

Lund, Sweden, 11 October, 2023. Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announced randomization for the US ConfIdeS trial is expected to conclude in mid-2024. The ConfIdeS trial is an open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care.¹ Hansa 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. Currently, 87 patients are enrolled in the trial at 16 activated trial sites with nine additional sites being initiated.

Søren Tulstrup, President and CEO, Hansa Biopharma said, “What we now know is that identifying and screening patients for this trial can take anywhere from one week to several months based on patient, donor and site-specific factors including overall patient health and proximity to the site. And, unlike other trials that can progress once patients meet certain criteria, this trial is largely dependent on allocation of suitable organs to consented patients. Organ allocation in the U.S. is managed by an independent third party. With this in mind, randomization is taking weeks and even months in most instances. We appreciate the ongoing commitment and dedication of participating trial centers and are committed to advancing this important clinical trial.”

The ConfIdeS trial is evaluating imlifidase as a potential desensitization therapy to enable kidney transplants in highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. The study’s primary endpoint is kidney graft function at 12 months, measured by eGFR (estimated Glomerular Filtration Rate) in highly sensitized kidney patients following an imlifidase-enabled kidney transplant. 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) disease²
•    Investigator-initiated trial in ANCA-associated vasculitis: Three of 10 targeted patients enrolled in this single-center, single arm Phase 2 trial³ 
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 imlifidase⁴
•    15-HMedIdeS-09 (Guillain-Barré 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 patients⁵ 
•    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 episodes⁶
•    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 SEK 16.5 million is product sales. September year to date (YTD) revenue is SEK 83.7 million, of which SEK 60.4 million is product sales.

 During the third quarter several new supply agreements with leading transplant centers in Europe have been secured, which is expected to translate into increased commercial sales in the fourth quarter and the periods to come, supported by new markets such as U.K., Germany, and Belgium where patient identification is ongoing as organs become available.

Total cash and equivalents stood at SEK 908 million (USD 83m) end of September 2023 which is expected to finance Hansa’s operations into 2025, as previously guided.

Hansa to publish its interim report for January-September 2023 at 8:00 CET on October 26, 2023
All interested parties are invited to participate in a telephone conference, which will include a presentation of the interim results and a business update, on the same date at 14:00 CET/8:00am EST. The event will be hosted by Hansa Biopharma’s CEO, Søren Tulstrup, CCO and US President, Matthew Shaulis and CFO, Donato Spota. The presentation will be held in English.

Slides used in the presentation will be live on the company website during the call under “Events & Presentations” and will also be made available online after the call. Link to presentation

To participate in the telephone conference, please use the dial-in details provided below:
Sweden: +46 812 410 952
United Kingdom: +44 203 769 6819
United States: +1 646 787 0157
Participant access code: 765135

The webcast will be available on https://hansabiopharma.eventcdn.net/events/q3-2023-conference-call 

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above, at 18:35 CET on October 11 2023.