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Peter Lougheed Centre Joins the Phase II Trial of LSALT Peptide for the Treatment of Complications in Hospitalized COVID-19 Patients

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Arch Biopartners Inc. announced that the Peter Lougheed Center in Calgary has joined its Phase II trial for the LSALT peptide (Metablok), aimed at preventing acute lung and kidney injuries in COVID-19 patients. This center is the second in Calgary to participate, following the University of Calgary's Foothills Medical Centre. Patient enrollment is ongoing in the U.S., while Turkish sites await health ministry approval for expansion. The trial aims to evaluate LSALT peptide's efficacy and safety in reducing organ inflammation associated with severe COVID-19 outcomes.

Positive
  • Peter Lougheed Center joins Phase II trial, expanding enrollment capabilities.
  • Ongoing patient enrollment in multiple countries, including the U.S.
  • Potential for LSALT peptide to address significant health challenges related to COVID-19.
Negative
  • Turkish sites awaiting health ministry approval may delay patient enrollment.
  • No effective antiviral drug currently exists for treating severe COVID-19.

TORONTO, Feb. 26, 2021 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that the Peter Lougheed Center (PLC) in Calgary, Alberta has joined the Phase II trial of its lead drug LSALT peptide (Metablok), 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.

PLC is the second hospital in Calgary to participate in the trial, joining University of Calgary Cumming School of Medicine at the Foothills Medical Centre that started enrolling patients last month. PLC enrolled its first patient into the study earlier this week.

Patient enrollment is ongoing in the United States. Sites in Turkey continue to wait for permission from the Turkish Ministry of Health to expand enrollment there.

“We welcome Peter Lougheed Centre into the study and expect to finish dosing in the trial in the coming weeks,” 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 (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). ARDS is the leading cause of death in COVID-infected patients. AKI has been observed in approximately 35% of patients admitted to hospital with COVID-19 and is also a leading cause of mortality.1

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, kidneys, and other organs.

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 program, 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 diseases, 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-2.2

1 Hirsch JS et al. Acute kidney injury in patients hospitalized with COVID-19. Kidney Int. 2020 doi: https://doi.org/10.1016/j.kint.2020.05.006.
2 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 61,362,302 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

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release


FAQ

What is the significance of the Peter Lougheed Center joining the Phase II trial for LSALT peptide (ACHFF)?

The Peter Lougheed Center's participation expands the trial's enrollment capacity, potentially accelerating data collection and results.

How many hospitals are participating in the Phase II trial for LSALT peptide (ACHFF)?

Currently, two hospitals in Calgary are participating in the trial, including the Peter Lougheed Center and the University of Calgary's Foothills Medical Centre.

What are the main goals of the Phase II trial for LSALT peptide (ACHFF)?

The trial aims to evaluate the effectiveness of LSALT peptide in preventing acute lung and kidney injuries in hospitalized COVID-19 patients.

What complications does the LSALT peptide (ACHFF) target in COVID-19 patients?

The LSALT peptide targets organ inflammation that can lead to acute respiratory distress syndrome and acute kidney injury.

When will the Phase II trial results for LSALT peptide (ACHFF) be used for further development?

The results from the Phase II trial will inform the design of the Phase III program, which will involve larger patient populations.

ARCH BIOPARTNERS INC ORD

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