We at Telara Pharma are thrilled to see our partner Arch Biopartners Inc (ARCH:TSXV) (ACHFF:OTCQB) announce the start of patient recruitment in the Phase II PONTIAK trial, evaluating cilastatin for the prevention of acute kidney injury (AKI) caused by drug toxins.
This marks a major step forward in validating cilastatin’s potential as a first-in-class therapy to protect patients from kidney damage associated with commonly used medications — including antibiotics, chemotherapy agents, and imaging dyes.
💡 The PONTIAK trial, led by top clinical teams in Canada is a testament to the growing recognition of cilastatin’s multi-organ protective potential.
The Phase II PONTIAK study aims to evaluate the efficacy of cilastatin in preventing AKI associated with nephrotoxic 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.