First Patient Dosed in Phase 2 Trial to Treat Complications in COVID-19

Arch Biopartners Inc. recently announced it has dosed the first patient in the Phase 2 trial of its lead drug LSALT peptide, targeting prevention of acute lung injury, acute kidney injury, and other complications caused by inflammation in hospitalized patients with moderate to severe cases of COVID-19.

The first patient dosed was at the Broward Health Medical Center in Florida where patient recruitment into the trial continues. Arch will begin screening and recruiting patients next week at clinical sites in Louisiana and in Turkey.

The Phase 2 trial is an international, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study of LSALT peptide (Metablok) 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).

The composite primary endpoint of the Phase 2 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 2 results will be used to design the Phase 3 trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID patients.

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 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.

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 pipeline of new drug candidates that inhibit inflammation in the lungs, liver, and kidneys via the dipeptidase-1 (DPEP-1) pathway for multiple medical indications. For more information on Arch Biopartners, its technologies, and other public documents Arch has filed on SEDAR, visit www.archbiopartners.com.