Arch Biopartners Submits IND Application to the FDA for Metablok (LSALT Peptide)

Arch Biopartners Inc. recently announced it has submitted an Investigational New Drug (IND) Application to the US FDA for its lead drug Metablok (LSALT peptide) to conduct a Phase 2 trial to prevent acute organ inflammation and injury experienced by patients with COVID-19.

The submission of the IND application was made by Arch following several weeks of review of the company’s Phase 2 plans by the FDA under the Coronavirus Treatment Acceleration Program.

The Phase 2 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 in COVID-19. The trial is expected to commence in the summer of 2020.

The primary endpoint of the Phase 2 trial is a composite that includes prevention of acute respiratory distress syndrome (ARDS), acute kidney injury (AKI), and acute liver injury. The composite reflects severe effects often experienced by hospitalized COVID-19 patients and Metablok’s novel mechanism of action in blocking consequential inflammation in these organs.

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 on respiratory, infectious diseases, and critical care medicine.

Survival rates and healthcare 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 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 neutrophil (white blood cell) adhesion receptor on the lung, liver and kidney endothelium.

A total of 40 out of 52 healthy, normal volunteers received Metablok during the recent placebo-controlled Phase 1 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, visit www.archbiopartners.com.