Metablok (LSALT peptide) Definition
Metablok is a novel peptide drug candidate and the lead DPEP-1 inhibitor for treating inflammation in the lungs, liver, and kidneys. Metablok is a new drug candidate for treating organ damage caused by inflammation and was originally invented to prevent organ inflammation related to sepsis.
The Company announced it has received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19.
DPEP-1 is identified as a major neutrophil (white blood cell) adhesion receptor on the lung, liver, and kidney endothelium.
On August 22, 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describes a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified for the first time as a major neutrophil (white blood cell) adhesion receptor on the lung, liver, and kidney endothelium.
In March 2020, Arch announced that we had successfully met the primary endpoints of safety and tolerability at the conclusion of a Phase I Human Trial conducted in Australia.
Arch Biopartners is now focused on beginning a Phase II Trial to investigate Metablok’s efficacy in treating inflammation-related lung injury in COVID-19 infected patients. In the worst cases of COVID-19 infection, fatalities are often linked to severe lung inflammation due to viral pneumonia, and subsequent respiratory failure.
Arch is a clinical-stage company developing new drug candidates for treating organ damage caused by inflammation.
Metablok (LSALT peptide) Indication
COVID-19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Patients with severe COVID-19 develop progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care. Patients with severe COVID-19 also experience multi-organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure, and blood abnormalities.
Dipeptidase 1 (DPEP1) serves as a vascular adhesion molecule in the lungs and liver. DPEP1 acts as a physical adhesion receptor independent of its dipeptidase activity. Targeting DPEP1 reduces mortality in murine models of sepsis
Metablok (LSALT peptide) Dosage
Experimental: Single Ascending Dose - Low Dose - LSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days.
Experimental: Multiple Ascending Dose LSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on the results of SAD arm. The LSALT will be administered intravenously once or twice daily for 3 days.
Metablok (LSALT peptide) News
May 8, 2020 - Arch Biopartners Inc., announced it has received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19. As a result of clinical interest to support the Phase II trial in the United States, Arch continues to be in dialogue with the U.S. Food and Drug Administration to obtain permission to recruit patients at American clinical sites into the trial.
April 23, 2020 - Arch Biopartners Inc. announced it has submitted a Clinical Trial Application to Health Canada for a Phase II human trial for its lead drug Metablok (LSALT peptide) to prevent lung and kidney inflammation in patients with COVID19.
December 18, 2019 - Arch Biopartners Inc. announced that the Phase I human trial of Metablok (LSALT peptide) has completed dosing of all scheduled volunteers and Metablok has met the primary endpoints of safety and tolerability.
August 22, 22019 - Dipeptidase-1 Is an Adhesion Receptor for Neutrophil Recruitment in Lungs and Liver.
Metablok Clinical Trials
Clinical Trial NCT03772678 - A phase I double-blind, placebo-controlled, randomized, single, and multiple ascending dose-finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants.
In March 2020, Arch announced the completion of our Phase I Trial conducted in Australia, designed to evaluate Metablok’s safety and pharmacokinetic profile. The Phase I trial was then extended to include an additional eight healthy volunteers. This final group received the highest daily dose of Metablok tested to date, for three consecutive days and met the primary endpoints of safety and tolerability.