Arch Biopartners initiates manufacturing process for Metablok

In pre-clinical studies, Metablok has shown it has the ability to prevent acute kidney injury by blocking the inflammatory response triggered by kidney ischemia/reperfusion.

Arch is planning a Phase I human trial to evaluate Metablok's safety and pharmacokinetic profile. The phase I study will be followed by Phase II clinical trials to evaluate the efficacy of Metablok in preventing cardiac surgery-associated acute kidney injury.

In pre-clinical studies, Arch scientists have demonstrated Metablok's ability to prevent acute kidney injury by blocking the inflammatory response triggered by kidney ischemia/reperfusion. Currently, there are no specific or effective treatments to prevent acute kidney injury.

An investigational new drug (IND) application to the FDA is currently being prepared by the Metablok team for submission in 2018.

"Acute kidney injury following cardiac surgery is a serious complication that is associated with an increased risk of death and other adverse effects. Advancing the pre-clinical development to prepare Metablok for a human trial is an exciting development for our drug that we believe will have a major clinical impact in patients at risk of acute kidney injury," said Dr Daniel Muruve, Chief Science Officer of Arch, Professor of Medicine and Chief of Nephrology at the University of Calgary.

CSBio is currently producing Metablok under good laboratory practice standards to enable toxicology and pharmacology studies needed to support a pre-IND submission meeting and subsequent IND application with the FDA.