Malmö, August 10th, 2022 – iCoat Medical AB (publ.), a clinical-stage pharmaceutical company developing novel therapeutics targeting the innate immune system, today announces that the first four patients included in a sentinel fashion into the ongoing First-in-Human trial ATMIRe, with the novel drug TUM012, have been treated without complications. The trial is expected to be completed during H1 2023.
- The first four patients included in a sentinel fashion into our First-in-Human trial ATMIRe, have been dosed, 2 patients with TUM012 and 2 patients with placebo without any serious or significant adverse effects
- TUM012 is the first drug being developed for kidney transplantations based upon iCoat Medical’s patented coating technology platform
- Topline data from ATMIRe is expected H1 2023
Ischemia reperfusion (IR) injury is an inevitable and harmful event during the process of organ transplantation that can trigger an injurious early inflammation deteriorating both the short and the long-term transplant outcomes. This initial inflammation occurs because of a direct interaction between injured cells of the kidney allograft and the recipient´s immune system. TUM012 is a promising drug candidate designed to effectively prevent the IR-induced inflammation by creation of a non-toxic barrier shielding off injured renal cells from recipient´s immune system.
This First-in-Human trial ATMIRe is a double-blind, placebo-controlled, randomized, single center trial to evaluate the safety, tolerability and pharmacokinetics of ex vivo kidney allograft treatment with TUM012. The trial will include 18 patients with 3-months follow-ups and is performed at the Skåne University Hospital in Malmö, Sweden.
“Initial Data from the first four patients in our ATMIRe trial, that have been reported and reviewed by an independent Data Monitoring Committee, confirm the feasibility and the good safety profile of TUM012 treatment. This is an important milestone for iCoat Medical´s development program for introduction of new global standards in kidney transplantations,” says Peder Waern, CEO of iCoat Medical.
For further information, please contact:
Peder Waern, CEO – iCoat Medical AB