07:11:29 EDT Sat 18 May 2024
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Arch Biopartners Inc
Symbol ARCH
Shares Issued 62,755,633
Close 2024-01-02 C$ 1.45
Market Cap C$ 90,995,668
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Arch receives Turkish MoH OK for phase II LSALT trial

2024-01-03 10:32 ET - News Release

Mr. Richard Muruve reports

ARCH BIOPARTNERS RECEIVES APPROVAL FROM THE TURKISH MINISTRY OF HEALTH TO PROCEED WITH PHASE II TRIAL FOR LSALT PEPTIDE TARGETING CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY

Arch Biopartners Inc. has received approval in Turkey from the Ministry of Health to proceed with a phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.

With the Ministry of Health (MoH) approval for the trial, Arch can now proceed to contract and activate clinical sites in Turkey. Patient enrolment is planned to start in February, 2024.

Quote from Richard Muruve, chief executive officer of Arch Biopartners:

"Following the approval from the MoH, we look forward to starting patient enrolment in Turkey while we wait for approval from Health Canada to do the same in Canada."

Cardiac surgery-associated acute kidney injury (CS-AKI) and LSALT peptide

CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI.

LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown to prevent IRI to the kidneys in preclinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial.

Details of the phase II trial, entitled "Phase 2 Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of LSALT peptide for the Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery," can be viewed on the ClinicalTrials website.

The Science Advances publication, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury" by Lau et al., can be found at the journal's website.

Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the company in March, 2023, will significantly offset the costs of the CS-AKI phase II trial.

Incidence of cardiac surgery-associated acute kidney injury (CS-AKI)

Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30 per cent and is independently associated with an increase in morbidity and mortality.

About Arch Biopartners Inc.

Arch Biopartners is a late-stage clinical trial company focused on preventing inflammation and acute organ injury. The company is developing new drug candidates that inhibit inflammation in the lungs, kidneys and liver via the dipeptidase-1 (DPEP-1) pathway and are relevant for common injuries and diseases where organ inflammation is an unmet problem.

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