Arch Biopartners Completes Enrollment in Phase II Trial of Metablok (LSALT Peptide) in Hospitalized Patients with COVID-19

Rhea-AI Summary

Arch Biopartners Inc. (ACHFF) has completed enrollment for its Phase II trial of Metablok (LSALT Peptide), aimed at treating acute lung and kidney injuries caused by inflammation in severe COVID-19 cases. A total of 65 patients participated, with results expected in July 2021. The trial is designed to assess Metablok's efficacy in preventing organ inflammation that can lead to severe complications in COVID-19 patients. Positive outcomes may inform a Phase III program with a larger patient cohort.

Positive

• Completion of patient enrollment for Phase II trial of Metablok.
• Potential for Metablok to address severe inflammation in COVID-19 patients.

Negative

• Results from the Phase II trial are pending, creating uncertainty for investors.

TORONTO, May 04, 2021 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“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, today announced it has completed enrollment for its Phase II study of Metablok (LSALT Peptide), targeting acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19. The Company expects to announce results in July 2021.

A total of 65 patients were randomized into the double-blind, placebo-controlled trial and 61 of these patients received at least one treatment dose.

“We would like to thank all of the patients and their families, as well as our clinical site teams in Canada, Turkey and the USA, for helping us achieve our patient enrollment target for this Phase II 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 (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) or new variants of the virus. 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 hospitalized patients at risk to inflammation in the lungs, kidneys or liver.

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. 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-2² or the many variants that have emerged globally in recent months.

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 Metablok (LSALT peptide) and DPEP-1

Metablok (also known as LSALT peptide) is a novel therapeutic agent and the lead DPEP-1 inhibitor in the Arch development pipeline.

A scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins first described a novel mechanism of action for organ inflammation in the journal Cell in August, 2019. In the publication, the enzyme DPEP-1 was identified for the first time as a major neutrophil adhesion receptor on the lung, liver and kidney endothelium. Their findings identified DPEP-1 as a novel therapeutic target for diseases of these organs where inflammation plays a major role.

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.

Continuing under development in the Arch portfolio are: AB569, a potential new treatment for antibiotic resistant bacterial infections in wounds and the lungs; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease bacterial biofilm on various medical grade metals and plastics.

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 61,462,302 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 Arch Biopartners Inc. (ACHFF) doing in its Phase II trial?

Arch Biopartners is conducting a Phase II trial for its drug Metablok (LSALT Peptide) to treat acute lung and kidney injuries in COVID-19 patients.

When will Arch Biopartners announce results from the Phase II trial?

Results from the Phase II trial are expected to be announced in July 2021.

How many patients were enrolled in Arch Biopartners' Phase II trial?

A total of 65 patients were enrolled in the Phase II trial.

What are the primary concerns addressed in the Phase II trial of Metablok?

The trial aims to prevent organ inflammation that can lead to acute respiratory distress syndrome and acute kidney injury in COVID-19 patients.

What is the significance of Metablok in COVID-19 treatment?

Metablok may help reduce severe complications caused by inflammation in COVID-19, potentially improving patient outcomes.