FDA Grants Arch Biopartners Permission to Proceed with Phase II trial to Evaluate Metablok (LSALT peptide) for the Treatment of COVID-19 patients
International, multi-center, randomized, double-blind, placebo-controlled clinical study targeting the prevention of Acute Respiratory Distress Syndrome (ARDS) and Acute Kidney Injury (AKI) in patients infected with COVID-19
Novel Mechanism of Action - a selective dipeptidase-1 antagonist that prevents leukocyte adhesion to endothelial cells reducing inflammation and subsequent organ damage
Study also recently approved by Health Canada
TORONTO, June 16, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc.
(“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), a clinical stage company developing new drug candidates for treating organ damage caused by inflammation, today announced that the U.S. Food and Drug Administration (FDA) has granted permission to the Company to proceed with a Phase II trial in the U.S. for its lead drug Metablok (LSALT peptide) to prevent acute lung and kidney injury experienced by patients with COVID-19.
The decision by the FDA to authorize the initiation of the Phase II trial came following the Company’s submission of an Investigational New Drug application to the FDA late last week.
The Phase II trial, which was cleared recently by Health Canada to proceed, will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in sixty patients infected with SARS-CoV-2 (COVID-19). The Company expects to begin the Phase II trial before the end of the summer, 2020.
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 multiple organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure, and blood abnormalities. Currently, no approved vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of severe COVID-19 has been primarily supportive, relying heavily on respiratory, infectious disease and critical care medicine.
Survival rates and health care system capacity could both be improved with new treatments that prevent the severe manifestations of COVID-19, such as worsening lung inflammation (ARDS) and AKI experienced by patients infected with SARS-CoV-2.
About Arch Biopartners
Arch Biopartners Inc. is a clinical stage company focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch is developing a drug pipeline to produce new drug candidates that inhibit inflammation in the lungs, liver and kidneys caused via the dipeptidase-1 (DPEP-1) pathway.
Metablok (LSALT peptide) is a novel peptide drug candidate and the lead DPEP-1 inhibitor in the Arch development pipeline. In August 2019, a scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins published a paper in the journal Cell describing a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified for the first time as a major leukocyte (white blood cell) adhesion receptor on the lung, liver and kidney endothelium. LSALT differs from typical anti-inflammatory drugs by targeting this novel adhesion receptor rather than targeting individual cytokines, of which there are over 30 currently known.
A total of 40 out of 52 healthy, normal volunteers received Metablok during the recent placebo-controlled Phase I human trial. In all cases, Metablok was well tolerated during the trial and no significant drug-related adverse effects were observed.
For more information on Arch Biopartners, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.com
The Company has 59,882,302 common shares outstanding.
All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time. The science and medical contents of this release have been approved by the Company’s Chief Science Officer.
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