07:47:46 EDT Sat 04 May 2024
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Arch Biopartners Inc
Symbol ARCH
Shares Issued 62,755,633
Close 2024-04-15 C$ 2.38
Market Cap C$ 149,358,407
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Arch adds St. Michael's Hospital to LSALT trial

2024-04-16 11:51 ET - News Release

Mr. Richard Muruve reports

ST. MICHAEL'S HOSPITAL JOINS THE PHASE II TRIAL OF LSALT PEPTIDE TARGETING CARDIAC SURGERY ASSOCIATED-ACUTE KIDNEY INJURY

A research team from St. Michael's Hospital, a site of Unity Health Toronto, has joined Arch Biopartners Inc.'s 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.

"Our research team is excited to be participating in this trial. Organ injury and repair is a Unity Health Toronto Research Pillar, and we are committed to investigating key mechanisms underlying tissue injury and healing, and to developing therapies to reduce injury and enhance regeneration," said Dr. David Mazer, translational researcher, anesthesiologist, and intensivist at St. Michael's Hospital.

The St. Michael's Hospital clinical team is awaiting ethics approval prior to beginning enrolment in the trial.

The addition of St. Michael's as the third Canadian clinical site increases the number of trial sites to nine, with six hospitals in Turkey currently recruiting patients.

The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria.

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 at clinicaltrials.gov. 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. There is no therapeutic treatment available in the market today that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances , titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury" by Lau et. al. and can be found along with previous peer-reviewed publications about DPEP-1 and LSALT peptide at the company'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% and is independently associated with an increase in morbidity and mortality.

About Arch Biopartners

Arch Biopartners Inc. 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.

For more information on Arch Biopartners' science and technologies, please visit: www.archbiopartners.com/our-science For investor information and other public documents the company has also filed on SEDAR+, please visit www.archbiopartners.com/investor-hub

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