(AGENPARL) – gio 07 dicembre 2023 Lund, Sweden, 7 December 2023. Hansa Biopharma, “Hansa” (Nasdaq Stockholm:
HNSA), today announced positive high-level data from the 15-HMedIdeS-09 phase 2
trial that demonstrated imlifidase was safe and well tolerated when administered
prior to standard of care, including rapid improvement in disease-related
efficacy measures. Further analysis of efficacy data will be conducted in 2024.
15-HMedIdeS-09 is an open-label, single arm, trial evaluating the safety,
tolerability and efficacy of imlifidase in GBS patients in combination with
standard of care (SoC) intravenous immunoglobulin (IVIg).
GBS is a rare, acute, paralyzing, inflammatory disease of the peripheral nervous
system caused by the immune system damaging nerve cells and structures. It
affects 1-2 in 100,000 people annually.[1] In GBS, rapid onset and progression
of muscle weakness occurs and can lead to severe paralysis of the arms and legs.
Approximately 25% of patients require mechanical ventilation for days to months
and 20% are unable to walk after six months.[2,3] Even with current standard of
care – either plasma exchange or immunoglobin therapy – GBS is fatal in 3-7% of
cases.[2,4]
Dr. Achim Kaufhold, Chief Medical Officer, Hansa Biopharma said, “The results of
15-HMedIdeS-09 are very encouraging. Imlifidase was safe and well tolerated, and
when compared to previously published data, a rapid improvement across several
efficacy outcome measures was observed in patients treated with imlifidase in
combination with standard of care. Immunoglobulin G (IgG) antibodies are thought
to play an important role in GBS disease. With its ability to rapidly cleave
IgGs, imlifidase could be a promising new option for halting this progressive
and oftentimes debilitating disease.”
Professor Shahram Attarian, Head of Department of Neuromuscular Diseases and
ALS, Hopitaux Universitaires de Marseille (APHM), and International Coordinating
Principal Investigator in the Phase 2 trial, said, “In the treatment of GBS,
reducing the long-term damage caused to the peripheral nervous system is key. In
severe patients, this damage can lead to long recovery times or even permanent
muscle weakness, pain, and fatigue. The immediate reduction of autoantibodies
could help stop the progression of the disease. I look forward to seeing the
full results of this trial to better understand how imlifidase may be able to
help more rapidly stop and revert the progression of GBS.”
Further analysis will contextualize efficacy data from the single arm 15
-HMedIdeS-09 study through a comparison to data from patients receiving standard
of care treatment in the International Guillain-Barré Syndrome Outcome Study
(IGOS) database. This analysis is expected to be completed and communicated in
2024.
More information about the trial is available at ClinicalTrials.gov under
— ENDS —
Notes to editors
About imlifidase
Imlifidase is a unique antibody-cleaving enzyme originating from Streptococcus
pyogenes that specifically targets IgG and inhibits IgG-mediated immune
response.[5] It has a rapid onset of action, cleaving IgG-antibodies and
inhibiting their activity within hours after administration. Imlifidase has
conditional marketing approval in Europe and is marketed under the trade name
Idefirix[®] for the desensitization treatment of highly sensitized adult kidney
transplant patients with a positive crossmatch against an available deceased
donor.
About 15-HMedIdes-09 Trial
15-HMedIdes-09 is an open-label, single arm, multi-center study across the UK,
France, and the Netherlands evaluating the safety, tolerability, and efficacy of
imlifidase in GBS patients in combination with standard of care (SoC)
intravenous immunoglobulin (IVIg). The administration of imlifidase prior to
standard of care in patients experiencing GBS proved to be safe, well tolerated,
and did not give rise to any safety concern. All subjects received a full dose
of imlifidase, and no serious adverse events caused by imlifidase infusion
related reactions were recorded.
About imlifidase and autoimmune diseases
Autoimmune diseases form a group of serious diseases caused by the immune system
attacking the body. In many autoimmune diseases the immune system mistakenly
recognizes the body’s own proteins as foreign and mounts an immune response,
creating antibodies to attack the body’s own cells and tissues. Pathogenic IgG
can contribute to a broad spectrum of autoimmune diseases.
Hansa is exploring how imlifidase may be able to prevent or slow the progression
of these diseases and their debilitating, life-threatening symptoms. Imlifidase
is currently being studied in the following autoimmune diseases: anti-glomerular
basement membrane (anti-GBM) disease, Guillain-Barré Syndrome, and ANCA
-associated vasculitis.
In 2018, the U.S. Food and Drug Administration granted Orphan Drug Designation
to imlifidase for the treatment of GBS.  Despite treatment with current standard
of care, GBS has a serious long-term impact on the patients’ work and private
life, even 3-6 years after the onset of illness. Recovery can be slow and take
years. Persistent disability is seen in 20%-30% of adult patients and severe
fatigue is a sequel of GBS in two thirds of adult patients.
About Hansa Biopharma
Hansa Biopharma is a commercial-stage biopharmaceutical company and pioneer in
immunoglobulin G (IgG)-cleaving enzyme technology on a mission to develop and
commercialize innovative, lifesaving and life-altering treatments for patients
with rare immunological conditions. Hansa has developed a first-in-class IgG
antibody-cleaving enzyme therapy, which has been shown to enable kidney
transplantation in highly sensitized patients. Hansa Biopharma is based in Lund,
Sweden, and has operations in Europe and the U.S. The Company is listed on
Nasdaq Stockholm under the ticker HNSA. Find out more at http://www.hansabiopharma.com.
References
1. McGrogan A, et al. Neuroepidemiology. 2009; 32(2):150-63
2. Fletcher D, et al. Neurology. 2000 27;54(12):2311-5
3. Van Doorn P. Presse Med. 2013;42(6 Pt 2):e193-201.
4. Van den Berg B, et al., Nat Rev Neurol. 2014; Aug;10(8):469-82
5. European Medicines Agency. Idefirix® summary of product characteristics.
Available at: https://www.ema.europa.eu/en/documents/product
-information/idefirix-epar-product-information_en.pdf.
Contacts for more information
Klaus Sindahl, Head of Investor Relations
Stephanie Kenney, VP Global Corporate Affairs
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Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden
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Hansa Biopharma AB, Scheelevägen 22, Lund, 22362 Sweden