Arch Biopartners Announces FDA Acknowledgement of its Investigational New Drug Application for Metablok (LSALT peptide)
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 SARS-CoV-2 (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 in Canada, additional filings made and planned globally
Phase 1 study in 52 healthy male and female subjects is complete with LSALT peptide meeting primary endpoint of safety and tolerability
TORONTO, June 15, 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 received and acknowledged the Investigational New Drug (IND) Application for its lead drug Metablok (LSALT peptide), enabling Arch to initiate a Phase II trial in the U.S. to prevent acute lung and kidney organ injury experienced by patients with COVID-19.
The submission of the IND application to the FDA was recently made by Arch. The Company expects to begin the Phase II trial before the end of the summer, 2020.
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 as prevention of acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in sixty patients infected with SARS-CoV-2 (COVID-19).
Following guidance and discussion with the FDA during the review of the protocol, the primary endpoint of the Phase II trial was expanded to a composite that includes prevention of ARDS and AKI. The composite reflects severe effects often experienced by hospitalized COVID-19 patients and deemed appropriate for Metablok’s novel mechanism of action in blocking consequential inflammation in these organs.
“Due to the current pandemic, the Phase II trial for Metablok has been quickly accelerated by both the FDA and Health Canada. We look forward to beginning the trial later this summer and continuing our collaboration with the health agencies, as we try to increase survival rates in patients at risk of lung and kidney inflammation,” said Richard Muruve, CEO of Arch.
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.
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.
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 science and medical contents of this release have been approved by the Company’s Chief Science Officer
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