TORONTO, Aug. 04, 2020 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received independent Institutional Review Board (IRB) approval for the Phase II trial of its lead drug LSALT peptide (Metablok) targeting acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19.
An IRB is a U.S. Food and Drug Administration registered group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in the protocol to secure approval, or disapprove the study, typically due to safety concerns. This independent group serves an important role in the protection of the rights and welfare of human research subjects.
“The independent IRB approval will enable faster site initiation and patient recruitment for our trial in the U.S. Many of the hospital centers interested to participate in our Phase II trial accept independent IRB approval in place of their own in-house IRB committees that commonly meet every 4 to 6 weeks. We are currently evaluating 3 new hospital sites in the U.S. in addition to the first site already selected in Florida. We look forward to dosing the first patient as soon as site evaluations are complete and the LSALT peptide drug product is delivered to the sites,” said Richard Muruve, CEO of Arch Biopartners.
About the Phase II trial for LSALT Peptide
The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide 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.
The Phase II results will be used to design a Phase III trial, including higher patient numbers and optimal drug dosing. The completion of the current phase II trial will depend on the ongoing COVID-19 outbreak and number of hospitalized patients at risk of ARDS and AKI.
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 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.
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.
LSALT peptide (Metablok) 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 in pre-clinical models. 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 LSALT peptide during the recent placebo-controlled Phase I human trial. In all cases, Metablok was well tolerated during the trial and no significant drug-related adverse effects were observed.
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.
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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Arch Biopartners, Inc.