University of Calgary Joins the Phase 2 Trial of LSALT Peptide for the Treatment of Complications in Hospitalized COVID-19 Patients

Arch Biopartners Inc. RECENTLY announced the University of Calgary Cumming School of Medicine has joined the Phase 2 trial of its lead drug LSALT peptide (Metablok), targeting the 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.

“We are particularly excited in launching this study in Calgary given that this treatment has its roots in basic science work performed here at the University. This novel treatment adds to our local investigational therapeutic options for patients admitted to hospital with COVID-19 disease and has great potential to reduce complications from this and other severe diseases that frequently result in lung and kidney injury,” said Alain Tremblay MDCM, Professor at the Cumming School of Medicine, Respirologist and site principal investigator for the LSALT Phase 2 trial.

The addition of the Canadian site increases the number of countries participating in the Phase 2 trial to three, joining sites in the US and in Turkey. Arch is currently exploring opportunities to add additional clinical sites in all three countries where the number of hospitalized COVID-19 patients has grown significantly.

Hospitalizations of COVID-19 patients have been on the increase as infection rates have surged throughout the world. In the last 2 weeks of December, Canada has had over 90,000 new infections and over 14,000 of these have been in Alberta.

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). ARDS is the leading cause of death in COVID-infected patients. AKI has been observed in approximately 35% of patients admitted to hospital with COVID-19 and is also a leading cause of mortality.

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, kidneys, and other organs. Additional information about the Phase 2 trial can be found at: https://clinicaltrials.gov/ct2/show/NCT04402957

The Phase 2 results will be used to design the Phase 3 program, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 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 care¹. Patients with severe COVID-19 also experience multiple organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure, and blood abnormalities. Currently, no effective antiviral drug or specific treatment exists for SARS-CoV-2 infection. Treatment of severe COVID-19 has been primarily supportive, relying heavily on respiratory, infectious diseases, 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.