Arch Biopartners Receives Ethics Committee Approval in Turkey for Phase II Trial for LSALT Peptide
TORONTO, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the Istanbul University Ethics Committee 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.
The Ethics Committee approval of the trial will be followed by a regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-September. Once the trial is approved by the MoH, activation of clinical sites in Istanbul and Ankara will take place and patient enrollment into the trial will commence.
Recent data have shown an upswing in new COVID-19 infections and hospitalizations in Turkey, with over 1,700 new cases reported on September 8th compared with approximately 900-1000 daily new cases during July. There have been 22,000 reported new cases and over 600 related deaths since August 25th.
“We continue to work quickly with our Turkish partners to expand the LSALT peptide Phase II trial into Turkey. We look forward to a positive decision from the MoH, which will permit enrollment of Turkish COVID-19 patients into the trial. At the same time, we continue to progress on a day-to-day basis to enrol the first U.S patient into this trial,” said Richard Muruve, CEO of Arch Biopartners.
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 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.
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.
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.
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