Arch Biopartners’ Lead Drug LSALT Peptide to Enter the Canadian Treatments for COVID-19 (CATCO) Trial

• LSALT Peptide (LSALT) is a novel drug candidate that targets acute organ inflammation in the lungs, liver and kidneys which is common in moderate to severe cases of COVID-19, regardless of variant type.
• LSALT is the first novel therapeutic to join the Canadian Treatments for COVID-19 trial, a multi-centre adaptive, randomized, open-label, controlled clinical trial involving sixty-five hospitals across Canada.
• CATCO is being conducted in conjunction with the World Health Organization’s SOLIDARITY trial, in collaboration with countries around the world and with support from the CIHR-funded Canadian Network of COVID-19 Clinical Trials Networks.
• LSALT will be evaluated in the Canadian trial on the basis of results of its Phase II trial demonstrating that the LSALT group had less ventilation days than the placebo group. The CATCO trial will include a 320 patient arm to confirm LSALT’s safety and efficacy as a treatment for acute lung inflammation for hospitalized COVID-19 patients.
• Phase II findings provide a first-ever signal that the dipeptidase-1 enzyme (DPEP-1) is a potentially significant therapeutic target for acute lung inflammation in COVID-19 patients.
• CATCO trial is sponsored by the Sunnybrook Research Institute (SRI). SRI and CATCO leadership to obtain ethics committee and Health Canada approvals before administering LSALT to COVID-19 patients.

TORONTO, Dec. 01, 2021 (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 its lead drug candidate, LSALT Peptide (LSALT and “Metablok”) will enter the Canadian Treatments for COVID-19 (CATCO) human trial, a multi-centre adaptive, randomized, open-label, controlled study being conducted in sixty-five hospitals across Canada, in conjunction with the World Health Organization’s (WHO) SOLIDARITY trial, in collaboration with countries around the world and with support from the Canadian Institutes of Health Research (CIHR)-funded Canadian Network of COVID-19 Clinical Trials Networks. LSALT will be evaluated in the Canadian trial.

Based on results of the Phase II study completed earlier this year, the primary endpoint of the confirmatory clinical trial will be the difference in the number of respiratory support free days between study groups during the 28-day study period. The control group will receive standard of care and the drug group will receive standard of care plus LSALT. Based on the Phase II results, a total of 320 patients will be required in each study group to detect an unadjusted treatment difference of 3.35 days requiring ventilation with 90% power.

Secondary endpoints include mortality, differences in outcomes involving other organs affected by COVID-19, such as kidney, liver, and heart function, time of hospitalization and intensive care stay, healthcare resource utilization, and late follow-up at 12 months post hospitalization.

Sunnybrook Research Institute (SRI) is the sponsor of the CATCO trial. SRI has entered into a collaboration agreement with Arch Biopartners to use LSALT in a new arm of the CATCO trial. SRI and CATCO leadership will now seek ethics committee and Health Canada approvals before commencing the dosing of LSALT in the CATCO trial.

The Company’s responsibilities during the trial include supplying LSALT drug vials to support the trial until completion. Arch completed the manufacturing of a new supply of vials during the summer and autumn of this year and has enough drug supply on hand for the 320 patients scheduled to be dosed in the CATCO trial.

Overview of Phase II results; Details pending peer reviewed publication

LSALT is entering the CATCO trial on the basis of a positive clinical effect observed in a Phase II trial completed earlier this year and funded in part by Innovation Science and Economic Development (ISED) Canada’s Strategic Innovation Fund (SIF) which is part of the Canadian Government’s Plan to Mobilize Science to Fight COVID-19.

The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2 (COVID-19). Six clinical sites located in Canada, United States, and Turkey participated in the Phase II trial.

Sixty-one patients were enrolled in the study and randomized 1:1 to receive LSALT or placebo. Despite having older patients and having greater co-morbidities in the LSALT group, the unadjusted analysis of all patients in the trial demonstrated 22.8 ventilation-free days for the LSALT group compared to 20.9 days in the placebo group during the 28-day evaluation period. “Ventilation” was defined as a need for high flow oxygen therapy (≥ 6L/min), non-invasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Adjusting for age, body mass index (BMI), and PaO2/FiO2 ratio (a measure of lung disease severity), the difference in ventilation-free days was 6.7 days favoring the LSALT group vs. placebo.

There were no unexpected differences in adverse events between LSALT and placebo treated patients. LSALT was well tolerated with no safety issues related to the drug. The exploratory study was designed to detect a clinical signal of efficacy and was not powered for statistical significance. Based on the promising clinical signal observed in the patients who received LSALT in the Phase II trial, 320 patients are scheduled to be dosed in the CATCO trial in order to detect a statistically significant difference.

Full details of the Phase II study are currently under consideration at a peer-reviewed scientific journal and will be released as soon as they are published.

Phase II results provide a first-ever signal towards validating Dipeptidase-1’s role in the mechanism of action of organ inflammation in humans

These Phase II results provide key human data which, in conjunction with extensive preclinical studies, further support DPEP-1 as a relevant therapeutic target for diseases of the lung, liver and kidney where inflammation plays a major role. In addition to evaluating LSALT as a treatment of inflammation complications experienced by hospitalized COVID-19 patients, Arch Biopartners intends to pursue its strategy to develop new DPEP-1 targeting drugs and clinical indications outside of COVID-19.

Quotes

“Our support for Arch Biopartners’ development of their COVID-19 treatment is an important part of our plan to rebuild Canada’s bio-manufacturing and life sciences sector. Today’s announcement highlights how Canadian innovation can contribute to the global race to find treatments for COVID-19 and will help build Canada’s capacity to address future health emergencies.”

– The Honourable François-Philippe Champagne, Minister of Innovation, Science and Industry

“Testing treatments for COVID-19 that have the potential to help Canadians remains a critically important task. Having the ability to test treatments developed in Canada, in a Canadian trial funded by the Canadian Institutes of Health Research, is a critical element of the national COVID-19 response.”

– Drs. Rob Fowler, Srinivas Murthy, Principal Investigators of the Canadian Treatments for COVID-19 Trial

“Organ inflammation represents an unmet need in the medical world and is also a predictor of critical illness and mortality in COVID-19. A new medical treatment to block acute organ inflammation is urgently needed to improve patient outcomes. We look forward to working with Sunnybrook Research Institute and participating in the CATCO study to help improve outcomes for hospitalized patients who have organ inflammation.”

– Mr. Richard Muruve, Chief Executive Officer, Arch Biopartners

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 61,962,302 common shares outstanding.

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, 2021 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

CONTACT: For more information, please contact:

Richard Muruve
Chief Executive Officer
Arch Biopartners Inc
1 647 428 7031

Please send a message or subscribe for email alerts at the company website using the link here www.archbiopartners.com/contact-us

Media contact:
Megan Stangl
647-801-0120
megan@talkshopmedia.com