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Arch Biopartners Receives Approval to Perform Phase I Clincial Trial for Metablok in Australia
Mar. 19, 2019 08:40AM PST
Biotech InvestingArch Biopartners (TSXV:ARCH,OTCQB:ACHFF) has announced it has been granted approval by the Alfred Hospital Ethics Committee to perform a Phase I clinical trial for Metablok, the company’s lead drug candidate for acute kidney injury and other organ damage caused by inflammation. As quoted in the press release: The Phase I study will be a double-blind, …
Arch Biopartners (TSXV:ARCH,OTCQB:ACHFF) has announced it has been granted approval by the Alfred Hospital Ethics Committee to perform a Phase I clinical trial for Metablok, the company’s lead drug candidate for acute kidney injury and other organ damage caused by inflammation.
As quoted in the press release:
The Phase I study will be a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of Metablok in healthy participants. A successful Phase I trial will be followed by a Phase II trial to investigate Metablok’s efficacy in the prevention of acute kidney injury in cardiac surgery patients.
Results from the Phase I trial are expected later this year and Arch will provide updates as the trial gets underway near-term at the Alfred Hospital in Melbourne, Australia.
About Metablok (LSALT peptide)
Metablok (renamed “LSALT peptide” in Arch communications with the U.S. FDA) is a novel 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.
Cardiac Surgery-Associated Acute Kidney Injury
Acute kidney injury (AKI) represents an additional challenge for patients recovering from cardiac surgery. AKI occurs in approximately 30% of patients that undergo cardiac bypass surgery with 2-5% of patients requiring dialysis. For patients who recover from the need for dialysis or mild AKI, there is a greater likelihood they will develop chronic kidney disease in future than those who did not have AKI.
Currently, no specific therapies exist to prevent AKI. Worldwide, there are over one million patients per year that have cardiac surgery procedures.
Inflammation is known to contribute to AKI related to ischemia-reperfusion and other insults to the kidney that may occur in the course of cardiac surgery. Metablok is a novel therapeutic agent that may protect the kidneys and prevent AKI in patients undergoing cardiac surgery.