Arch Biopartners Inc. announced that the investigator-led Phase II trial titled "Prevention OfephroToxin Induced Acute Kidney Injury with Cilastatin" (PONTIAK) has commenced patient recruitment at its primary clinical sites in Alberta, Canada. The Phase II PONTIAK study aims to evaluate the efficacy of cilastatin in preventing AKI associated with neephrotoxic pharmaceuticals, which include commonly used drugs such as antibiotics, chemotherapy agents, and imaging dyes, some of which are known to cause kidney damage as a side effect. The trial plans to enrol approximately 698 patients in five hospital sites in Alberta.
The PONTIAK clinical team, based at the Universities of Calgary and Alberta, secured $1.5 million in funding for the Phase II trial from the Canadian Institutes of Health Research (CIHR), along with $400,000 under the Accelerating Clinical Trials (ACT) initiative aimed at evaluating Canadian biotechnologies using randomized controlled trials. Arch Biopartners recently manufactured the first-ever, stand-alone cilastatin drug product and has provided the drug supply for the trial. While the trial is investigator-led and independently funded, the Company is also evaluating opportunities to support a complementary arm of the study in another jurisdiction, such as the United States under an application to the U.S. Food and Drug Administration.
AKI reflects a broad spectrum of clinical presentations, ranging from mild injury to severe injury that may result in permanent and complete loss of renal function. Clinically, the causes of AKI include sepsis,ischemia-reperfusion injury, and various endogenous as well as exogenous (drug) toxins. Cilastatin was approved for use as a fixed combination with imipenem to treat different types of bacterial infections.
This fixed combination, approved by the FDA in 1985, is currently marketed under different names, including Primaxin®? (USA, UK, Australia, Italy), Tienam®? (Spain, Belgium), or Zienam®?
(Germany). Composition of matter patents for imipenem and cilastatin have expired, and the combination drug is currently in a generic phase. Arch Biopartners owns and has exclusively licensed method-of-use patents to repurpose cilastatin as a new treatment targeting AKI.
