Arch Biopartners Receives Health Canada Approval to Conduct COVID-19 Phase II Human Trial
The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide.
TORONTO, May 08, 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 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.
The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide. The primary endpoint is to prevent the development of life threatening acute respiratory distress syndrome (ARDS) in patients early in the course of COVID-19.
A secondary endpoint of the Phase II trial is to prevent kidney inflammation and injury, which also contributes to mortality and occurs in up to 30% of patients with severe COVID-19.
The trial will begin with the enrolment of 60 hospitalized patients who will receive either LSALT peptide or drug-free saline daily for up to 14 days. There will be an option to expand the study to include a larger number of subjects.
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.
About COVID-19
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. Currently, no vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of COVID-19 has been primarily supportive, relying on critical care physicians.
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 acute kidney injury 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 library to produce new drug candidates that inhibit inflammation in the lungs, liver and kidneys caused via the dipeptidase-1 (DPEP-1) pathway.
Metablok 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 neutrophil (white blood cell) adhesion receptor on the lung, liver and kidney endothelium.
A total of 40 out of 52 healthy, normal volunteers received Metablok during the recent Phase I human trial. In all cases, Metablok was well tolerated during this placebo-controlled trial and no significant drug-related adverse effects were observed.
Continuing under development in the Arch portfolio are: AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung and wounds; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease bacterial biofilm on various medical grade metals and plastics.
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.
Forward-Looking Statements
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.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release
For more information, please contact: Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 [email protected]
