Celdara Medical announces the publication of new translational research in the American Journal of Transplantation indicating that a novel polymer therapeutic candidate, APP-103TM, is able to preserve kidney function in preclinical models of kidney ischemia reperfusion injury, including transplantation. The results of the study, led by experts at Brigham and Women’s Hosptal and Beth Israel Deaconess Medical Center, provides a potential opportunity for expanded criteria kidney donation and much-needed hope for the roughly 750,000 Americans suffering from End-Stage Renal Disease (ESRD) who are awaiting a life-saving transplant.
End-Stage Renal Disease is the final stage of progressive and chronic loss of kidney function due to genetic and lifestyle factors. The best current treatment is a kidney transplant, but unfortunately, there is a shortage of donor organs leaving more than 100,000 ESRD patients on the US transplant waiting list each year. The majority of these patients will perish before receiving a kidney transplant. Currently, the only alternative to transplantation is dialysis, which consumes an estimated 7% of the medicare budget and costs approximately eight times more than kidney transplant.
The research team analyzed a novel polymer therapeutic, APP-103 TM, and showed that its use preserves kidney function through reduction of oxidative stress caused by ischemic reperfusion injury (IRI) in preclinical models. APP-103 TM is currently being developed by Celdara Medical to treat delayed graft function (DGF) in expanded criteria kidney donors. This will enable additional organs to be utilized for kidney transplantation. “APP-103 offers a unique and novel treatment targeting site-specific consequences of ischemia-reperfusion injury,” states Dr. Stefan Tullius, co-senior study author and Chief of Transplant Surgery at Brigham and Women’s Hospital in Boston.
IRI is the result of a required surgical process in kidney transplantation and has been shown to generate a high degree of oxidative stress and subsequent organ injury. APP-103 TM is a site-specific anti-oxidant and anti-inflammatory preclinical drug product that reduces organ damage following the IRI insult. The team has successfully demonstrated efficacy and safety throughout preclinical development. “Our data demonstrates that APP-103, which was developed with supports from the National Institutes of Health, is a novel, nontoxic, and site-activating therapeutic approach that effectively ameliorates the consequences of IRI in solid organ transplantation,” says co-senior study author and inventor of APP-103, Dr. Peter M. Kang, MD, Cardiologist and Director of the Cardiovascular Physiology Core at Beth Israel Deaconess Medical Center, also in Boston.
Brandy Houser, Ph.D., Site Head in NYC and the development lead for the APP-103 team at Celdara Medical, commented, “Having worked with Stefan and Peter and their respective teams for more than five years, we’re very happy to see these important results published. Our parallel translational initiative at Celdara Medical, has gone a long way to validating the clinical application and potential of this strategy, while significantly improving manufacturing, form, and formulation. It has also led to the discovery of improved compositions of matter. We are continuing to advance this therapy toward the clinic and are in discussions with strategic and financial partners who have the resources to increase both development speed and probability of success. Our goal remains clear: to help patients gain access to life saving kidneys.”
This work was supported by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health under award number DK103389.
Disclosure: Dr. Peter Kang is the Scientific Founder of the Anti-Inflammatory Therapeutics project at Celdara Medical, the company that is advancing APP-103 for clinical application.There’s a licensing agreement between BIDMC and Celdara for technology that Dr. Peter Kang invented.
For the full Journal article, visit: doi.org/10.1111/ajt.15794
About Celdara Medical, LLC
Celdara Medical gives hope and health to patients by transforming academic innovations into medicines with the potential to cure the world’s most challenging diseases. Celdara Medical is a recognized leader with a rich stable of discoveries, developed in concert with premiere research institutions in the US, EU, and beyond. We secure lasting partnerships with inventors and their institutions, and provide the developmental, financial, and business acumen to bridge the gaps between discovery and clinical impact. With robust funding options, operations in greater Boston, NYC, and Washington, DC, growing affiliates in Seattle and Indianapolis, a wealth of opportunities in our pipeline, and partnerships with industry leaders worldwide, Celdara Medical navigates the path from science to medicine, accelerating innovation to improve human health.