- Approval from FDA to initiate Phase II trial with LSALT peptide to target cardiac surgery-associated acute kidney injury (CS-AKI)
- LSALT peptide targets dipeptidase-1 (DPEP-1), an enzyme known to mediate organ inflammation in the lungs, liver and kidneys
- There are currently no treatments available to prevent or treat AKI
This decision follows the FDA’s review of the Company’s investigational new drug (IND) application submitted to the FDA’s
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
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. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. In the worst cases of AKI, kidneys fail leading to kidney dialysis or kidney transplant. 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.
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.
Recent funding contribution from the
Quote from
“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. 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.”
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.
LSALT Peptide Drug Product Manufacturing Update
During the last year, Arch advanced the production of a new supply of LSALT peptide to be used in new human trials. 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. 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.
About Cardiac Surgery-Associated 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 cardiac surgery-associated acute kidney injury (CS-AKI) is up to 30% and is independently associated with an increase in morbidity and mortality.
Cardiopulmonary bypass (CPB) surgery occurs in nearly 1 million patients per year. 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, 19981, Conlon et al, 19992, Zakeri et al, 20053, Ivert et al, 20144, Harky et al, 20205).
About LSALT Peptide and Dipeptidase-1 (DPEP-1) Mediated Organ Inflammation
LSALT peptide is a novel peptide drug candidate and DPEP-1 inhibitor. In
The Cell publication, titled “Dipeptidase-1 is an adhesion receptor for neutrophil recruitment in lungs and liver” by Choudhry et. al. can be found at the journal’s website.
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The Company has 62,398,825 common shares outstanding.
References:
1. Conlon PJ, Stafford-Smith M, White WD, et al. Acute renal failure following cardiac surgery. Nephrol Dial Transplant. 1999;14:1158–62
2. Chertow GM, Burdick E, Hoinour M, Bonventre JV, Bates DW. Acute kidney injury, mortality, length of stay, and costs in hospitalized patients. J Am Soc Nephrol. 2005;16:3365-70
3. Zakeri R, Freemantle N, Barnett V, et al. Relation between mild renal dysfunction and outcomes after coronary artery bypass grafting. Circulation. 2005;112(suppl):I270–5
4. Ivert T, Holzmann MJ, Sartipy U. Survival in patients with acute kidney injury requiring dialysis after coronary artery bypass grafting. Eur J Cardiothoracic Surg. 2014;45:312–7
5. Harky A, Joshi M, Gupta S, et al. Acute kidney injury associated with cardiac surgery: a comprehensive literature review. Braz. J. Cardiovasc. Surg. 2020;35(2).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT peptide (Metablok), the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in
The science and medical contents of this release have been approved by the Company’s Chief Science Officer
Neither
For more information, please contact:Richard Muruve Chief Executive OfficerArch Biopartners, Inc. 647-428-7031 info@archbiopartners.com
Source:
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