TORONTO, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the Veterans Affairs San Diego Healthcare System (VASDHS) has started recruiting patients for the Phase II trial of its lead drug LSALT peptide, 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.
“Acute lung injury and acute kidney injury are among the most serious consequences of COVID-19, and novel medications focused on preventing these organ failures have the potential to be life-saving. We are excited to be part of this research, and to give our Veterans the opportunity to participate in this trial,” said Dr. Mark Hepokoski, M.D. a pulmonary and critical care physician at the VASDHS and site principal investigator for the LSALT Phase II trial.
The VASDHS is the fifth hospital to be activated into the trial, joining sites in Florida and Louisiana, as well as two hospital sites in Turkey. Arch is currently exploring opportunities to add Canadian clinical sites into the trial as the number of hospitalized COVID-19 patients has grown significantly in Alberta and Ontario in recent weeks.
Hospitalizations of COVID-19 patients have been on the increase as infection rates have surged throughout the world. In the last month, California has experienced a spike in COVID-19 infection rates, with daily cases growing from approximately 3,000 cases in early October to over 25,000 daily cases. Infection rates in the U.S. are now at the highest level of the year, with over 200,000 daily cases reported this past week. COVID-19 infection rates in Turkey have similarly spiked to 30,000 daily cases, more than ten times the average daily numbers reported there in July.
About the Phase II trial for LSALT Peptide
The Phase II 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 II 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.
Additional information about the Phase II trial can be found at:
https://clinicaltrials.gov/ct2/show/NCT04402957
The Phase II results will be used to design the Phase III trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 patients.
About COVID-19
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 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.
1 J. S. Ayres, Sci. Adv 10.1126/sciadv.abc1518 (2020)
About Arch Biopartners
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, please visit www.archbiopartners.com
The Company has 60,782,302 common shares outstanding.
Forward-Looking Statements
All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.
The science and medical contents of this release have been approved by the Company’s Chief Science Officer
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain Covid-19 (or SARS-2 Coronavirus) at this time
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