Malmö, October 11th, 2022 – iCoat Medical AB (publ.) (“iCoat”), a clinical-stage pharmaceutical company developing novel therapeutics targeting the innate immune system, today announces that more than 50% of the intended patients in the ongoing First-in-Human trial with the novel drug TUM012 have been treated without complications linked to the IMP. The trial is expected to be completed during H1 2023.
- More than 50% of the intended patients have been included into iCoat Medical’s First-in-Human trial ATMIRe without any serious or significant adverse events linked to the Investigational Medicinal Product (IMP)
- 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 a 3-month follow-up period and is performed at the Skåne University Hospital in Malmö, Sweden.
“Having successfully treated more than 50% of the patients in the ATMIRe trial, we can confirm that TUM012 continues to indicate its feasibility and a good safety profile. This is another important milestone for iCoat Medical’s development program for introduction of new global standards in kidney transplantation and we look forward to report topline data when ATMIRe is concluded in 2023” says Peder Waern, CEO of iCoat.
For further information, please contact:
Peder Waern, CEO – iCoat Medical AB