Canadian Treatments for COVID-19 (CATCO) Trial Receives Approval from Health Canada to Amend Protocol to include LSALT Peptide (Metablok)
Arch Biopartners announced Health Canada's approval for the inclusion of its drug candidate LSALT Peptide in the CATCO clinical trial, aimed at treating organ inflammation in COVID-19 patients. The amendment allows LSALT to be used in a new dosing arm, with trials expected to begin after local approvals. The CATCO study involves up to 55 hospitals across Canada and targets approximately 350 patients suffering from complications due to COVID-19. LSALT's focus is on reducing organ inflammation irrespective of COVID-19 variants.
- Health Canada approved the amendment to the CATCO protocol for LSALT Peptide.
- The inclusion of LSALT in a new dosing arm could enhance its clinical trial opportunities.
- The CATCO trial is set to involve 55 hospitals, increasing patient recruitment potential.
- No immediate commercialization timeline for LSALT Peptide is provided, prolonging investor uncertainty.
LSALT Peptide (LSALT) is a novel drug candidate that targets acute organ inflammation in the lungs, liver and kidneys common in several indications, including moderate to severe cases of COVID-19, regardless of variant type
TORONTO, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch Biopartners”, “Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), a clinical stage company developing new drug candidates for treating organ damage caused by inflammation, announced today that Health Canada has approved the amendment to the CATCO protocol to include its lead drug candidate, LSALT Peptide (LSALT and “Metablok”) in a new dosing arm of the trial.
Health Canada has issued a No Objection Letter for the Clinical Trial Application – Amendment to the CATCO team as part of its approval process. Dosing of LSALT peptide is expected to begin following final local approval and clinical site preparation.
About CATCO
CATCO is a multi-centre, adaptive, randomized, open-label, controlled study being conducted in up to fifty-five hospitals across Canada to find new treatments for patients suffering from the complications caused by COVID-19. CATCO is supported by the Canadian Network of COVID-19 Clinical Trials Networks which is funded by the Canadian Institutes of Health Research.
Sunnybrook Research Institute (SRI) is the sponsor of the CATCO trial and administers the trial across all sites in Canada. SRI has entered into a collaboration agreement with Arch Biopartners to use LSALT in a new arm of the CATCO trial. The Company’s primary responsibility during the trial is the supply of LSALT drug vials to support the dosing of up to approximately 350 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.
Although vaccination has proved effective in limiting the severity of COVID-19, vaccine hesitation, limited vaccine access globally as well as the emergence of new SARS-CoV-2 variants has perpetuated the global pandemic. 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. Targeting inflammation to lessen the severity of COVID-19 is a therapeutic strategy that should not be impacted by the emergence of SARS-CoV-2 variants.
1Wong, LY., Perlman, S. Immune dysregulation and immunopathology induced by SARS-CoV-2 and related coronaviruses — are we our own worst enemy?. Nat Rev Immunol (2021). https://doi.org/10.1038/s41577-021-00656-2
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, relevant 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 62,120,292 common shares outstanding.
Other Corporate Items – Correction to Feb 8, 2022 Press release
An error was made in the Arch press release of Feb 8, 2022 in regard to the interest period that was used to calculate the interest debt for shares settlement. The press release should read: “the Company has arranged a shares for debt transaction to settle an aggregate of
For more information, please contact:
Richard Muruve
Chief Executive Officer
Arch Biopartners Inc
1 647 428 7031
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Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on Arch Biopartners’ management’s beliefs and assumptions and on information currently available to Arch Biopartners’ management. All statements, other than statements of historical fact, in this news release are considered 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. One can identify forward-looking statements by terms such as "may", "will", "should", "could", “would”, "outlook", "believe", "plan", "anticipate", "expect" and "estimate", or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, statements regarding the potential efficacy and safety of LSALT Peptide (LSALT) in patients who have inflammation of the lungs and other organs such as the liver and kidneys; the ongoing clinical development of LSALT in future human trials and other indications outside of COVID-19 patients.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: results observed in pre-clinical in-vivo studies; previous human trials including a Phase I and a Phase II trial where LSALT was dosed in human patients; the past performance of the network of hospitals involving other trials and the dosing of other treatments for COVID-19 patients; the ability of participating hospitals to enroll enough patients to complete the study of LSALT in the planned number of COVID-19 patients; and the COVID-19 pandemic worsening or lessening will not adversely affect the development of LSALT and other DPEP-1 targeting therapeutics in Arch Biopartners’ portfolio of new drugs under development.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, the risk that results (whether safety or efficacy, or both) obtained through the administration of LSALT in humans will not be similar to those obtained in pre-clinical studies or in the previously completed Phase I and Phase II trials; the risks that the hospitals participating in the CATCO trial are unable to enroll enough patients to complete the study of LSALT as a treatment for organ inflammation in COVID-19 patients; or, that serious adverse effects resulting from the administration of LSALT are discovered leading to a suspension or cancellation of any development work using LSALT; and, the risk that new organ inflammation treatments are discovered or introduced by competitors which may prove safer and/or more effective than LSALT.
We refer potential investors to the "Risk Factors" section of our annual Management and Discussion and Analysis dated January 28, 2022 available on SEDAR at www.sedar.com and on our website at at www.archbiopartners.com for additional risks regarding the conduct of Arch Biopartners’ business and enterprise in general. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent management’s expectations as of that date.
Arch Biopartners’ management undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
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
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