• LSALT is the first novel therapeutic to join the Canadian Treatments for COVID-19 trial, a multi-centre adaptive, randomized, open-label, controlled clinical trial involving sixty-five hospitals across Canada.
  • CATCO is being conducted in conjunction with the World Health Organization’s SOLIDARITY trial, in collaboration with countries around the world and with support from the CIHR-funded Canadian Network of COVID-19 Clinical Trials Networks.
The Science Explained:
Animal Studies:

“Using biochemical, genetic, and confocal intravital imaging approaches, we identified dipeptidase-1 (DPEP1) as the target and established its role as a physical adhesion receptor for neutrophil sequestration independent of its enzymatic activity. Importantly, genetic ablation or functional peptide blocking of DPEP1 significantly reduced neutrophil recruitment to the lungs and liver and provided improved survival in models of endotoxemia.”

Phase I Human Clincal Trial:
 
  • Trial Completed March 31, 2020
  • NCI Common Terminology Criteria for Adverse Events 
  • ClinicalTrials.Gov
  • Trial Expansion to better prepare for potential Phase II needs
Phase II Human Clinical Trial:
 
  • Trial Completed May 6, 2021
  • Funded in part by Innovation Science and Economic Development (ISED) Canada’s Strategic Innovation Fund (SIF) 
  • Six clinical sites located in Canada, United States, and Turkey participated in the Phase II trial.
  • ClinicalTrial,Gov
Sixty-one patients were enrolled in the study and randomized 1:1 to receive LSALT or placebo. Despite having older patients and having greater co-morbidities in the LSALT group, the unadjusted analysis of all patients in the trial demonstrated 22.8 ventilation-free days for the LSALT group compared to 20.9 days in the placebo group during the 28-day evaluation period. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT group vs. placebo.

Phase II results provide a first-ever signal towards validating Dipeptidase-1’s role in the mechanism of action of organ inflammation in humans
Phase III/Covid Trial Human Clinical Trial:
 
  • a multi-centre adaptive, randomized, open-label, controlled study being conducted in sixty-five hospitals across Canada
  • being conducted in conjunction with the World Health Organization’s SOLIDARITY trial
  •  support from the Canadian Institutes of Health Research (CIHR)-funded Canadian Network 
  •  Based on the promising clinical signal observed in the patients who received LSALT in the Phase II trial, 320 patients are scheduled to be dosed in the CATCO trial in order to detect a statistically significant difference.
Patent Position:
Market Potential:
 
  • COVID19 - Organ Inflammation
  • acute respiratory distress syndrome (ARDS)
  • acute kidney injury (AKI)
    • Currently, no specific therapies exist to prevent AKI in the world today. Management of AKI is supportive and includes life-sustaining therapy with dialysis. Patients that experience AKI are at high risk of developing chronic kidney disease, adverse cardiovascular outcomes and death.The worldwide market for AKI is estimated to be over $20 billion USD per year. ($325.4 dollars a share)
    • Acute Kidney Injury
Share Structure:
 
  • The Company had 47,360,179 Common Shares outstanding as of May 7, 2010. As of the date hereinabove, the Company has 61,862,302 common shares outstanding.
  • No warrants outstanding
Previous Financing:

  • Dec 23, 2020 (One Placee)
announced it has closed the non-brokered private placement the Company disclosed in a press release December 23, 2020 (The “Offering”). Pursuant to the Offering, Arch issued 430,000 common shares priced at CAD $1.50 per common share (the “Common Shares”) for net proceeds of $500,000 USD (approximately $645,000 CAD) (the “Offering”).
  • June 30, 2020 (Two Placee)
The Company announced it closed a non-brokered private placement offering of 900,000 common shares priced at $1.50 per common share (the “Common Shares”) for gross and net proceeds of up to $1,350,000 (the “Offering”).
 
  • Feb 2, 2018 (One Placee)
The Company announced it arranged a non-brokered private placement offering of up to 2,500,000 common shares priced at $0.50 per common share (the “Common Shares”) for gross proceeds of up to $1,250,000 (the “Offering”).

Government Support:
  • “Our support for Arch Biopartners’ development of their COVID-19 treatment is an important part of our plan to rebuild Canada’s bio-manufacturing and life sciences sector. Today’s announcement highlights how Canadian innovation can contribute to the global race to find treatments for COVID-19 and will help build Canada’s capacity to address future health emergencies.”

– The Honourable Franois-Philippe Champagne, Minister of Innovation, Science and Industry
 

  • “As the world works toward an effective COVID-19 vaccine, we cannot lose sight of the importance of developing treatments to keep those stricken with the virus alive. Today’s contribution will support Arch Biopartners in taking its promising treatment through clinical trials and subsequent approvals. Once approved, this drug has the potential to be an important tool to save lives, improve long-term health and reduce the strain on Canada’s medical system. Investments like these help not only protect and support Canadians through this pandemic but also lay the foundation for a better-prepared, healthier and more prosperous future.”

 – The Honourable Navdeep Bains, Minister of Innovation, Science and Industry
 

Quote from CEO:
 

  • “Organ inflammation represents an unmet need in the medical world and is also a predictor of critical illness and mortality in COVID-19. A new medical treatment to block acute organ inflammation is urgently needed to improve patient outcomes. We look forward to working with Sunnybrook Research Institute and participating in the CATCO study to help improve outcomes for hospitalized patients who have organ inflammation.”

    – Mr. Richard Muruve, Chief Executive Officer, Arch Biopartners