- Arch Biopartners (TSXV:ARCH) has submitted applications to the Ministry of Health and Ethics Committee in Turkey for a Phase II trial
- The trial will be for the company’s LSALT peptide targeting prevention and treatment of cardiac surgery-associated acute kidney injury
- LSALT peptide is Arch Biopartners’ lead drug candidate to prevent and treat inflammation injury in the kidneys, lungs and liver
- Shares of Arch Biopartners are down 6.21 per cent to C$1.36 as of 11:50 a.m. ET.
Arch Biopartners (TSXV:ARCH) is gearing up for a Phase II trial in Turkey for its lead drug candidate LSALT peptide to target prevention and treatment of cardiac surgery-associated acute kidney injury (AKI).
In a news release, the Toronto-based company said it has submitted applications to the Ministry of Health as well as the Ethics Committee in Turkey so it can proceed with the trial.
The trial plans to enlist up to 240 patients and will be a double-blind, placebo-controlled study conducted in hospital sites in the United States, Turkey and Canada.
Out of the 240 patients, roughly 150 patients will be recruited in Turkey.
The trial is expected to begin in Q4 2023 with initial patient recruitment in Turkey followed by onboarding in the U.S. and Canada.
“We are very happy to be returning to Turkey to begin a Phase II human trial targeting CS-AKI, which is a large unmet medical problem,” Richard Muruve, CEO of Arch Biopartners, said in a statement. “As a result, Arch is on schedule to dose the first patient in the fourth quarter of 2023.”
The application follows Arch Biopartners’ submission to the U.S. Food and Drug Administration (FDA) of an investigational new drug application, which was granted by the FDA to the company in June.
LSALT peptide intends to prevent and treat inflammation injury in the kidneys, lungs and liver.
Cardiac surgery-associated AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) in the kidney, causing kidney cell damage.
The company’s drug candidate has indicated it can prevent ischemia-reperfusion injury to the kidneys in pre-clinical models.
Arch Biopartners Inc. is a late-stage clinical trial company focused on preventing inflammation and acute organ injury.
Shares of Arch Biopartners are down 6.21 per cent to C$1.36 as of 11:50 am ET.
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