Arch Biopartners announced 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.
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“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.