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 it has chosen its first U.S. clinical site for the Phase II trial of its lead drug LSALT peptide (Metablok). Broward Health Medical Center (BHMC) in Florida has agreed to participate in the trial and begin enrolling patients following internal review board approval, which is expected during the month of August 2020.
The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of organ inflammation known to trigger acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2 (COVID-19). BHMC will be among other hospitals in the United States, and elsewhere, that will enroll a total of sixty patients into the trial.
The composite primary endpoint of the phase II trial reflects the severe effects often experienced by hospitalized COVID-19 patients and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in the lungs and kidneys.
The Phase II results will be used to design a larger Phase III trial, including patient numbers and optimal drug dosing. The completion of the current phase II trial will depend on the ongoing COVID-19 outbreak and number of hospitalized patients at risk of ARDS and AKI.
COVID-19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Severe complications from COVID-19 are in large part due to excessive host immune responses to the virus that result in progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care1. 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.
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