"It is encouraging that the final study results confirm our previous promising observations, providing us a clear path forward for the dosing of RMC-035 in kidney transplantation. We are now looking forward to the results of our ongoing Phase 2 study in cardiac surgery as a decision-making basis for the next development step of RMC-035," said Tobias Agervald, CEO of
All eight patients in the study received treatment with RMC-035. The open-label study without a control arm aimed to evaluate the pharmacokinetics and safety of RMC-035 in the context of kidney transplantation. RMC-035 was administered once daily for five days, with a total of five doses, within the dosage range of 0.3 to 0.6 mg/kg. The first dose was administered during the surgical procedure, i.e., the kidney transplantation itself.
In parallel, a global Phase 2 study (AKITA) is underway to evaluate the kidney-protective effect of RMC-035 in patients undergoing open-heart surgery. Top-line results from the AKITA study are expected to be available during the autumn in 2023 and will form the basis for the continued clinical development of RMC-035 in both heart surgery and kidney transplantation.
About RMC-035
RMC-035 represents a completely new class of drugs (first-in-class) and consists of a recombinant and modified variant of the endogenous protein alpha-1-microglobulin. The investigational drug has the ability to protect cells and their mitochondria from damage caused by oxygen deprivation and elevated levels of the oxygen-binding and toxic protein heme. Promising treatment effects of RMC-035 have been observed in various preclinical disease models. RMC-035 has a natural affinity for the kidneys and is primarily being developed as an intravenous kidney-protective treatment for patients at high risk of developing acute kidney injury (AKI).
RMC-035 has received an Investigational New Drug (IND) approval from the
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