![]() Approximately 0.6% to 5% of patients undergoing cardiac surgery will require immediate postoperative dialysis or RRT, and these patients have a very high early mortality rate up to 25% compared with 1% to 2% in patients who do not require immediate postoperative dialysis (Chertow et al, 1998 1, Conlon et al, 1999 2, Zakeri et al, 2005 3, Ivert et al, 2014 4, Harky et al, 2020 5).Ībout LSALT Peptide and Dipeptidase-1 (DPEP-1) Mediated Organ Inflammation The reported prevalence of cardiac surgery-associated acute kidney injury (CS-AKI) is up to 30% and is independently associated with an increase in morbidity and mortality.Ĭardiopulmonary bypass (CPB) surgery occurs in nearly 1 million patients per year. The new vials completed quality control and quality assurance procedures at the Company’s third-party manufacturing facility and have been moved to storage, pending delivery to clinical sites.Īcute 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 production of approximately 10,000 LSALT peptide drug product vials were recently completed and have been released for human use to support human trials. LSALT Peptide Drug Product Manufacturing Updateĭuring the last year, Arch advanced the production of a new supply of LSALT peptide to be used in new human trials. We look forward to taking LSALT peptide to trial patients who are at risk to CS-AKI, as there are currently no treatments available to prevent or treat AKI.”ĭetails 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. “The FDA’s decision to grant a Study May Proceed letter is the culmination of 18 months of work by the Arch team to scale up LSALT manufacturing, perform dose escalation studies for LSALT peptide and complete significant planning and preparation for the CS-AKI trial. Quote from Richard Muruve, CEO of Arch Biopartners Inc: Recent funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the Company in March 2023, will significantly help cover the costs of this Phase II trial. The Science Advances publication, titled “ Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. LSALT peptide has been shown to prevent ischemia reperfusion injury (IRI) to the kidneys in pre-clinical models, providing the scientific rationale for using LSALT peptide in this CS-AKI trial. 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. ![]() Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. This study is designed to produce a signal of efficacy that would justify a larger Phase III trial.Ĭardiac 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. There will be an independent Data Safety Monitoring Board which will monitor the safety of the patients enrolled in the trial. Patient recruitment is expected to begin in the fall of 2023, pending approvals from local health authorities, ethics committees and internal review boards. The CS-AKI trial has plans to recruit up to 240 patients and will be a double-blind, placebo-controlled study conducted in hospital sites in the U.S., Turkey, and Canada. The IND application included preclinical data, Phase I and Phase II clinical data to date, manufacturing processes, and the protocol design for the CS-AKI Phase II trial. This decision follows the FDA’s review of the Company’s investigational new drug (IND) application submitted to the FDA’s Division of Cardiology and Nephrology on May 26, 2023. LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the lungs, liver and kidneys. Food and Drug Administration (FDA) for a Phase II human trial for LSALT peptide targeting cardiac surgery-associated acute kidney injury (CS-AKI). ![]() TORONTO, J(GLOBE NEWSWIRE) - Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received a “Study May Proceed” letter from the U.S.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |