Arch Biopartners, Inc., a portfolio-based biotechnology company, announces it has joined forces with Nucro-Technics in Scarborough, Ontario to complete the preclinical toxicology and pharmacology studies to support an Investigational New Drug (IND) application for Metablok, the company’s drug candidate for preventing acute kidney injury.
Metablok (renamed “LSALT peptide” in Arch communications with FDA) is a peptide drug candidate in the Arch development pipeline and a potential treatment for the following highly problematic indications: (i) inflammation, (ii) sepsis and (iii) cancer metastasis.
Specifically, Nucro-Technics will be performing the good laboratory practice (GLP) toxicology and pharmacology studies previously confirmed by the U.S. Food and Drug Administration (FDA) during the pre-IND meeting with the company.
Arch is preparing an IND application and a Phase I human trial to evaluate Metablok’s safety and pharmacokinetic profile in advance of future clinical trials to test its efficacy in treating or preventing cardiac surgery-associated acute kidney injury.
Acute kidney injury due to ischemia/reperfusion occurs in up to 30% of patients undergoing cardiovascular surgeries. Inflammation is involved in the pathogenesis of many diseases and contributes significantly to acute kidney injury.
Nucro-Technics looks forward to continuing to advance Arch Biopartners drug candidate Metablok through to clinical stages. “We are pleased to support Arch Biopartners upcoming IND application for Metablok by performing the required toxicology and pharmacology studies,” says John C. Fanaras, president of Nucro-Technics.