iCoat Medical, a clinical stage pharmaceutical company focusing on reducing and preventing ischemia reperfusion injuries (IRI) during organ transplantation, today announced it has established a Scientific Advisory Board to strengthen iCoat Medical’s research and development programs. Three leading international experts in the field have signed up and been added to the Scientific Advisory Board: Dr. Gabriel Oniscu, Dr. Stefan Schneeberger and Dr. Stefan Tullius.
“Establishing a Scientific Advisory Board is an important step for iCoat and our goal of improving the outcomes of organ transplantations. I am very pleased and proud that we have been able to attract some of the leading global transplant experts in the field,” said Peder Waern, CEO at iCoat Medical.
“Their long, combined experience in research and treatment is invaluable for us as we continue to progress the clinical development of our leading drug candidate iCM012 in the upcoming Phase 2b study EMPIRe to demonstrate efficacy,” he continues.
The EMPIRe study is iCoat’s next step in clinical development of iCM012 in deceased-donor kidney transplantation and is judged by iCoat to be regarded as the logical next step by regulatory bodies to advance the successful Phase 1/2a study ATMIRe.
The upcoming study, which is planned to start in 2024, will include approximately 100 patients and be performed at selected high-quality sites in Europe and the U.S. The potential for conditional approval, given sufficiently convincing data generated by the Phase 2b study, will later be discussed with the regulatory authorities.
New members of the Scientific Advisory Board:
Dr. Gabriel Oniscu
Dr. Gabriel Oniscu is transplant surgeon with a clinical focus on multi-organ transplantation and kidney donation and has a Doctor of Medicine from the University of Edinburgh. He is currently Professor of Transplantation Surgery at Karolinska Institute in Stockholm, and prior was the Director of the Edinburgh Transplant Centre, lead clinician for novel organ perfusion and preservation technologies and Transplant Advisor to the Chief Medical Officer in Scotland. Dr Gabriel Oniscu also holds the presidency of European Society of Organ Transplantation (ESOT).
Dr. Stefan Schneeberger
Dr. Stefan Schneeberger is a Professor and Director, Department of Visceral, Transplant and Thoracic Surgery at the Medical University of Innsbruck. He has a clinical focus in transplantation and hepatobiliary surgery, and a great interest in research concerning transplantation and ischemia/reperfusion injury. Previous experience includes Adjunct Associate Professor of Surgery, Department of Plastic Surgery, Johns Hopkins Medical University in Baltimore, MD, USA, and former President of the European Society of Organ Transplantation (ESOT).
Dr. Stefan Tullius
Dr. Stefan Tullius is the Chief of Transplant Surgery at Brigham and Women’s Hospital and Professor of Surgery, Harvard Medical School. His research career in transplantation immunology spans more than 15 years. His work on chronic graft rejection has contributed greatly to an improved understanding of the pathophysiology of long-term graft failure. His more recent research interests include individualized immunosuppression and the investigation of basic mechanisms of clinically relevant aspects in organ transplantation, focusing on novel routes for the improvement of organ quality.
Already, iCoat Medical has two leading Key Opinion Leaders associated to the company, Professor Stephen Sacks, Director of the MRC Centre for Transplantation and Head of Department of Nephrology & Transplantation at King’s College London, and Professor Raja Kandaswamy, Director of Pancreas and Intestinal Transplant Program and Vice Chief, Division of Transplantation at University of Minnesota.
For more information, please contact:
Peder Waern, CEO – iCoat Medical AB
E-mail: peder.waern@icoatmedical.com
Mattias Springare, CFO and Head of Investor Relations – iCoat Medical AB
E-mail: mattias.springare@icoatmedical.com
About iCoat Medical
iCoat Medical is a clinical stage, pharmaceutical company focusing on reducing and preventing ischemia reperfusion injuries by developing novel pharmaceutical products. The company is one of the world’s leading R&D-centered organizations within innate immunology and is systematically expanding its pipeline using its proprietary coating-technology platform. iCoat Medical’s lead candidate iCM012 is developed to improve the outcome of organ transplantations. The company’s unique ex-vivo coating of the grafts has the ambition of being an integral part in the transplant procedures of tomorrow. iCoat Medical has operations in Uppsala, Lund and Malmö, and is headquartered in Stockholm.
For more information, please visit https://www.icoatmedical.com/sv/
About iCM012
iCM012 is an innovative pharmaceutical compound designed for ex vivo allograft treatment aiming to mitigate IRI and safeguard organ functionality post transplantation. iCM012 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and by European Commission.
About IRI and the kidney transplant market
IRI is a serious complication that arises during organ transplantation resulting in detrimental short-and long-term graft outcomes. In kidney transplantation, IRI contributes to DGF which occurs in about 20-40% of deceased donor kidney transplantations.
Total number of kidney transplants in 2021 amounted to 36,000 in Europe and the US. Kidney transplants have increased over time with most kidneys originating from deceased donors. iCM012 can provide value for all transplanted kidney recipients but the population with higher risk of IRI, such as recipients of kidneys with high KDPI scores, will benefit the most.
The total annual market potential for iCM012 in the initial target population amounts to up to $850M-1.2B in Europe and the US, using a price estimated based on possible cost savings incurred from reducing short- and long-term effects of IRI and DGF.