Statistically significant reduction in donor-specific antibodies (DSAs) observed among imlifidase patients within five days of treatment as compared to standard of care
In the trial, the primary endpoint was the maximum reduction in DSA level at any time point during the 5 days following the start of treatment. Patients treated with imlifidase demonstrated a statistically significant reduction of DSAs by 94.4% compared to a 35.6% (p-value: <0.001) reduction in patients who received standard of care (plasma exchange, or PE). DSA levels subsequently returned to approximately 70% of the initial level in both treatment arms.
The secondary endpoint investigated overall kidney function following treatment. The imlifidase arm demonstrated a 74% six-month graft survival and eGFR of 30mL/min/1.73m2. A 100% six-month graft survival and eGFR of 33mL/min/1.73m2 was observed in the PE arm. Given the heterogeneity of the patient population, the trial was not designed nor sufficiently powered to be able show a statistically significant difference in the secondary outcome measures. Imlifidase demonstrated a safety profile consistent with previous clinical trials.
Dr.
Prof.
The AMR patient population is heterogeneous, consisting of both chronic patients - those who experience slow rejection after a transplant, and which often results in irreversible damage to the organ - and acute patients who experience AMR early post-transplant. Additionally, AMR can be driven by a combination of antibodies and T-cells-mediated action (CMR - cell mediated rejection), creating additional complexity when it comes to treatment strategy. Treatment guidelines indicate reduction of DSA levels as one of the main goals of any AMR treatment.1 To date, there are no approved therapies for the treatment of AMR, and all current treatments including standard of care are used off-label.1
More information about the trial is available at ClinicalTrials.gov: NCT03897205.
This is information that
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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.2 It has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within hours after administration. Imlifidase has conditional marketing approval in
About 16-HMedIdes-12
16-HMedIdes-12 is randomized, open-label, multi-center, controlled phase 2 trial designed to evaluate safety, tolerability, and efficacy of imlifidase compared to plasma exchange (PE) in removal of DSAs in patients experiencing active and chronic active AMR episodes. The trial included 30 patients with AMR randomized to receive either imlifidase or PE in a 2:1 ratio.
About imlifidase and autoimmune diseases
Autoimmune diseases occur when the immune system mistakenly recognizes the body's own proteins, as foreign and mounts an immune response, creating antibodies against the body's own cells and tissues. Many autoimmune diseases are driven by pathological IgGs.
About
References
- Schinstock CA, et al. Transplantation. 2020 May;104(5):911-922.
- EDQM. (2020). International figures on donation and Transplantation 2019
https://news.cision.com/hansa-biopharma-ab/r/imlifidase-met-primary-endpoint-in-16-hmedides-12-phase-2-trial-in-patients-with-amr-following-kidne,c3894073
https://mb.cision.com/Main/1219/3894073/2496348.pdf
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