Arch Biopartners Expands the Primary Endpoint of its Phase II Trial to Include Prevention of Multiple Organ Injuries in Patients with COVID-19
TORONTO, May 19, 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 expanded the primary endpoint of the Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation and injury experienced by patients with COVID-19.
The expansion of the primary endpoint reflects recent global data from COVID-19 patients that shows the SARS-CoV-2 virus results in damage to organs besides the lungs and Metablok’s potential to prevent inflammation injury in multiple organs.In addition to acute respiratory distress syndrome (ARDS), the primary endpoint of the Phase II trial now includes acute kidney injury (AKI), cardiomyopathy, acute liver injury, coagulopathy and all-cause mortality as components of a composite endpoint in hospitalized COVID-19 patients. Studies have shown that COVID-19 results in 35% mortality with AKI1 and 40% mortality with cardiomyopathy2. Further, acute liver injury3 and thrombotic disease4 have resulted in poor outcomes in COVID-19 patients.The Phase II trial, which was recently cleared by Health Canada to proceed, will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide. The trial is expected to commence in the summer of 2020.Arch has recently made progress and 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.1Hirsch, Kidney Int. 2020
2Akhmerov, Circ Res. 2020
3Lee, J Chin Med Assoc. 2020
4Llitjos, J Thromb Haemost 2020About COVID-19COVID-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 approved vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of severe 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 AKI experienced by patients infected with SARS-CoV-2.About Arch BiopartnersArch 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.comThe Company has 59,882,302 common shares outstanding.For more information, please contact:Forward-Looking StatementsAll 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