- Data readout demonstrates a significantly superior capacity of
imlifidase to rapidly reduce levels of donor-specific antibodies
(DSAs) compared to plasma exchange (standard of care) in the five
days following the start of the treatment.
- A total of 30 patients have been randomized 2:1 to either
imlifidase or plasma exchange with a six-month follow up
period.1
- These first results are an important milestone in executing on
Hansa's strategy to expand the reach of its IgG antibody cleaving
technology platform to address significant unmet medical needs in a
wide spectrum of disease areas and indications.
LUND,
Sweden, Nov. 28, 2022 /PRNewswire/ -- Hansa
Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme
technology for rare immunological conditions, today announces
positive topline data from its phase 2 study evaluating safety,
tolerability, and efficacy of imlifidase in reducing donor specific
antibodies (DSAs) in patients with active and chronic active
antibody mediated rejection (AMR) episodes. This data readout
follows the completion of randomization and subsequent treatment of
all enrolled patients and is in line with previously indicated
timelines.
The topline data associated with the primary endpoint shows that
imlifidase has significantly superior efficacy compared to plasma
exchange in reducing DSAs during the five days following the start
of treatment. Imlifidase effectively reduced the majority of DSAs
in the patient population, achieving these results more rapidly and
with significantly higher reduction levels compared to plasma
exchange, which required multiple sessions to obtain adequate DSAs
reduction. With regard to safety, imlifidase was well tolerated,
and no safety signals were encountered during the study. Hansa
plans to publish the full dataset from the study in 2023.
AMR is one of the most challenging adverse events after kidney
transplantation and it constitutes a main cause for graft
dysfunction and loss, with acute AMR episodes occurring in 5-7% of
kidney transplants.2 There are currently no approved
therapies for the treatment of AMR, with the most commonly used
treatments being intravenous immune globulin (IVIg) and therapeutic
plasma exchange (PLEX).
"Acute AMR episodes post-transplantation and chronic AMR remain
significant problems which can cause damage and loss of the organ,
and force patients to revert to dialysis. The performance and
rapidity of imlifidase which we have observed in this study is very
promising and could open up new opportunities for improving the
therapies for post-transplant AMR" says Prof. Stanley Jordan MD, Principal Investigator,
Director of Division of Pediatric and Adult Nephrology at Cedars
Sinai Medical Center, Los
Angeles.
"What we are seeing from the first readout of our AMR phase 2
trial is very encouraging and provides further evidence of the
potential imlifidase may have for management of transplant
rejection", says Christian Kjellman,
Chief Scientific Officer, Hansa
Biopharma. "Current protocols can take up to several weeks
to reach the desired effect, and in some cases the outcome remains
incomplete or ineffective. There is a clear need to provide
patients experiencing post-transplant AMR with a more rapid and
effective therapy that can quickly diminish DSAs, thereby
minimizing the risk of damage to the kidney. Every organ
successfully transplanted with longer graft-survival is a
life-changing opportunity for patients and a benefit to society at
large".
Hansa's AMR phase 2 program is a randomized, open-label,
multi-center, controlled study, with a total of 30 randomized AMR
patients across centers in France,
Germany, Austria, Australia, and the
United States. The primary objective of the study is to
investigate the efficacy and safety of imlifidase compared to
plasma exchange (PE) in removal of DSAs in patients who are
experiencing an active or chronic active AMR episode after kidney
transplantation. A total of 20 individuals have been randomized to
receive imlifidase treatment comprised of one intravenous dose of
0.25mg/kg, while 10 individuals in the active control arm received
5-10 sessions of plasma exchange. Efficacy and safety are monitored
over a six- month period post treatment.
More information about the trial is available at
ClinicalTrials.gov under NCT03897205 (2019).
References
- ClinicalTrials.gov. NCT03897205 (2019). Available at:
https://clinicaltrials.gov/ct2/show/NCT03897205
- Puttarajappa C, et al. J. Transplant. 2012; 2012:193724
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 below, at 18:00 CET on
November 28 2022.
CONTACT:
For further information, please contact:
Klaus Sindahl, Head of Investor
Relations
Hansa Biopharma
Mobile: +46 (0) 709-298 269
E-mail: klaus.sindahl@hansabiopharma.com
The following files are available for download:
https://mb.cision.com/Main/1219/3674141/1699894.pdf
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20221128 HNSA AMR
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