Arch Biopartners Announces FDA Acknowledgement of its IND Application

Arch Biopartners Inc. recently announced the US FDA has received and acknowledged the Investigational New Drug (IND) Application for its lead drug Metablok (LSALT peptide), enabling Arch to initiate a Phase 2 trial in the US 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 2 trial before the end of the summer, 2020.

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 as prevention of acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in 60 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 2 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.

“Due to the current pandemic, the Phase 2 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.

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 leukocyte (white blood cell) adhesion receptor on the lung, liver and kidney endothelium. LSALT differs from typical anti-inflammatory drugs by targeting this novel adhesion receptor rather than targeting individual cytokines, of which there are over 30 currently known.

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.