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HNSA   ( ,  %) SEK
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With our clinical and preclinical research programs we evaluate imlifidase across a wide spectrum of both potential disease areas and indications.

Preclinical Phase 1 Phase 2 Phase 3 Marketing
authorization
Marketed

Imlifidase

EU: Kidney transplantation in highly sensitized patients

EU: Kidney transplantation in highly sensitized patients

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Next anticipated milestones
EU: Additional agreements around reimbursement / Post approval study to be completed by end of 2025

Status
Commercialization ongoing based on approval.

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

US: Kidney transplantation in highly sensitized patients

US: Kidney transplantation in highly sensitized patients

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Next anticipated milestones
Data readout in 2H 2025

For more information: NCT04935177

Status
Clinical Phase 3 ongoing.

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)

Anti-GBM disease

Anti-GBM disease

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Next anticipated milestones
Complete enrollment (50 patients)

For more information: NCT05679401

Status
Clinical Phase 3 ongoing.

Antibody mediated kidney transplant rejection (AMR)

Antibody mediated kidney transplant rejection (AMR)

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Next anticipated milestones
Publication in peer-reviewed journal

For more information: NCT03897205

Status
Clinical Phase 2 ongoing.

Guillain-Barré syndrome (GBS)

Guillain-Barré syndrome (GBS)

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Next anticipated milestones
Comparative efficacy analysis 2024

For more informations: NCT03943589

Status
Clinical Phase 2 ongoing.

Investigator initiated trial in ANCA-associated vasculitis

ANCA-associated vasculitis

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Next anticipated milestones
Complete enrollment (10 patients)

Notes

  • Phase 2, first patient enrolled
  • Investigator sponsored trial (IST) by Dr. Adrian Schreiber and Dr. Philipp Enghard, at Charité Universitätsmedizin, Berlin, Germany

Pre-treatment ahead of gene therapy in Duchenne Muscular Dystrophy (Partnered with Sarepta)

Pre-treatment ahead of gene therapy in Duchenne Muscular Dystrophy (Partnered with Sarepta)

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Next anticipated milestones
Completion of enrollment

Status
Clinical phase 1b ongoing.

Pre-treatment ahead of gene therapy in Limb-Girdle Muscular Dystrophy (Partnered with Sarepta)

Pre-treatment ahead of gene therapy in Limb-Girdle Muscular Dystrophy (Partnered with Sarepta)

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Status
Preclinical research.

Pre-treatment ahead of gene therapy in Pompe disease (Partnered with AskBio)

Pre-treatment ahead of gene therapy in Pompe disease (Partnered with AskBio)

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Status
Preclinical research.

Pre-treatment ahead of gene therapy in Crigler-Najjar syndrome (Partnered with Genethon)

Pre-treatment ahead of gene therapy in Crigler-Nailar syndrome (Partnered with Genethon)

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Status
Commence clinical study

HNSA-5487

Lead molecule from second-generation lgG antibody cleaving enzymes (NiceR)

Lead molecule from second-generation lgG antibody cleaving enzymes (NiceR)

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Next anticipated milestone
Further analysis around endpoints from Phase 1 to be completed in 2024 and clinical development path.

Status
Clinical phase 1 ongoing.

Ongoing
Completed
Planned
Post approval study running in parallel with commercial launch

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 IST-review@hansabiopharma.com.

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 medinfo@hansabiopharma.com. We anticipate acknowledging receipt of requests within 5 business days.  For information regarding Hansa clinical trials, please visit:

clinicaltrials.gov