Pipeline
With our clinical and preclinical research programs we evaluate imlifidase and HNSA-5487 across a spectrum of both potential disease areas and indications.
Imlifidase
EU: Kidney transplantation in highly sensitized patients
Commercialization ongoing based on approval
Post approval study running in parallel with commercial launch.
EU: Kidney transplantation in highly sensitized patients
Next anticipated milestones
EU: Additional agreements around reimbursement / Post Approval Efficacy and Safety (PAES) study to be completed in 2026.
Notes
- Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7)
- Lorant et al, American Journal of Transplantation and 03+04 studies (Jordan et al New England Journal of Medicine)
- The EU Commission has granted conditional approval for imlifidase in highly sensitized kidney transplant patients. As part of the conditional approval Hansa has committed to do a post-approval study
U.S. “ConfIdeS”: Kidney transplantation in highly sensitized patients
Clinical Phase 3 ongoing
U.S. “ConfIdeS”: Kidney transplantation in highly sensitized patients
Next anticipated milestones
Data readout in 2H 2025
For more information: NCT04935177
Notes
- Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7)
- Lorant et al, American Journal of Transplantation and 03+04 studies (Jordan et al New England Journal of Medicine)
GOOD-IDES-02: Anti-GBM antibody disease
Clinical Phase 3 ongoing
GOOD-IDES-02: Anti-GBM antibody disease
Next anticipated milestones
Data readout in 2025
For more information: NCT05679401
16-HMedIdes-12: Active Antibody Mediated Rejection (AMR)
Clinical Phase 2 completed
16-HMedIdes-12: Active Antibody Mediated Rejection (AMR)
Next anticipated milestones
-
For more information: NCT03897205
15-HMedIdeS-09: Guillain-Barré Syndrome (GBS)
Clinical Phase 2 completed
15-HMedIdeS-09: Guillain-Barré Syndrome (GBS)
Next anticipated milestones
Publication in peer-reviewed journal
Preparation of Phase 3 trial
For more informations: NCT03943589
Investigator initiated trial in ANCA-associated vasculitis
Clinical Phase 2 ongoing
Investigator initiated trial in ANCA-associated vasculitis
Next anticipated milestones
Complete enrollment (10 patients)
Notes
- Investigator sponsored trial (IST) by Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charité Universitätsmedizin, Berlin, Germany
SRP-9001-104: Pre-treatment ahead of gene therapy in Duchenne Muscular Dystrophy (DMD)
Partnered with Sarepta Therapeutics
Clinical phase 1b ongoing
SRP-9001-104: Pre-treatment ahead of gene therapy in Duchenne Muscular Dystrophy (DMD)
Next anticipated milestones
Complete enrollment
Pre-treatment ahead of gene therapy in Crigler-Najjar syndrome
Partnered with Genethon
Clinical Phase 2 ongoing
Pre-treatment ahead of gene therapy in Crigler-Najjar syndrome
Next anticipated milestones
Complete enrollment
HNSA-5487
NICE-01: HNSA-5487 – Lead candidate from the NiceR program
Clinical Phase 1 completed
NICE-01: HNSA-5487 – Lead candidate from the NiceR program
Next anticipated milestones
Preparation of clinical trial design in myasthenia gravis following alignment with BfArM.
Sponsored research
We believe it is important to support ethical independent clinical research conducted by qualified third-party investigators (investigator sponsored trials or ISTs). Investigators are encouraged to submit study concepts to Hansa Biopharma.
Investigators can reach out to one of our medical science liaisons (MSL) or alternatively email the Company’s Investigator Sponsored Trial Review Committee at [email protected].
Interested in being part of a clinical trial?
If you are a patient and interested in participating in one of Hansa’s clinical trials or studies, please talk to your physician.
Compassionate use
Hansa is committed to leveraging our unique immunomodulating technology platform to develop innovative, lifesaving, and life-altering treatments for patients with rare immunologic conditions. As we take our commitment to patients very seriously, Hansa shares your urgency as we strive to develop new treatments and complete the rigorous scientific and regulatory requirements. We firmly believe that conducting thorough clinical trials to evaluate safety and efficacy, and securing regulatory approval, is paramount to ensuring that our treatments reach as many patients as possible.
As a result, we are unable to offer a compassionate use program at this time without jeopardizing our ability to conduct the trials needed to gain timely regulatory approval and provide patients broad, equitable, and sustainable access. We believe the most appropriate way to access our investigational therapies is to participate in clinical trials assessed by regulatory entities across the globe. Completing our current and future clinical trials, with diligence and efficiency, remains the best path to potential regulatory approval and ensuring widespread access to our therapies.
Hansa will continue to evaluate the possibility of compassionate use and will update our policy if our position changes. Physicians seeking more information can contact [email protected]. We anticipate acknowledging receipt of requests within 5 business days. For information regarding Hansa clinical trials, please visit: