Arch Biopartners Provides Update on Phase II Trial for LSALT Peptide

Rhea-AI Summary

Arch Biopartners has announced ongoing analysis of its Phase II trial results for the LSALT peptide (Metablok), aimed at preventing organ inflammation due to COVID-19. The trial involved multiple clinical sites and evaluated the drug's effectiveness against ARDS and AKI. Recruitment was completed in May, with data reconciliation finalized in June, allowing analysis to start in July. The company plans to disclose results after peer review and aims to use the findings to inform a future Phase III program.

Arch's pipeline includes LSALT peptide as a DPEP-1 inhibitor, with patent protection for cilastatin to prevent acute kidney injury.

Positive

• Ongoing analysis of Phase II trial for LSALT peptide may lead to valuable insights for future trials.
• Successful recruitment and data collection from multiple clinical sites indicates strong operational execution.
• Potential to address significant medical needs related to COVID-19 complications.

Negative

• No specific results or data disclosed at this time, leaving uncertainty about the drug's efficacy.
• Dependence on peer review process before public results can be shared could delay next steps.

TORONTO, Aug. 05, 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 provided an update that the analysis of the results of the Phase II trial of its lead drug LSALT peptide (Metablok) is ongoing and will be disclosed to the public following third-party, scientific peer review.

After the recruitment of the last patient into the trial in early May, the Company’s Phase II data team reconciled the patient data collected from the seven clinical sites that participated in the trial. The database containing the trial data was then locked at the end of June, which enabled the start of data analysis in late July. All of the Phase II clinical sites in Canada, the U.S. and Turkey have been officially closed.

About LSALT Peptide and Organ Inflammation

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.

LSALT peptide (also known as Metablok) is a novel therapeutic agent and the lead DPEP-1 inhibitor in the Arch peptide drug pipeline. Arch also has patent protection to re-purpose the small molecule cilastatin, a known DPEP-1 inhibitor, for the prevention of acute kidney injury caused by inflammation in several different indications.

About the Phase II trial for LSALT Peptide

The Phase II trial was 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). ARDS is the leading cause of death in COVID-infected patients.

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 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 the status of Arch Biopartners' LSALT peptide Phase II trial results?

Arch Biopartners is currently analyzing Phase II trial results for the LSALT peptide, with findings to be disclosed after peer review.

When did the Phase II trial for LSALT peptide complete patient recruitment?

The Phase II trial completed patient recruitment in early May.

What is the significance of the LSALT peptide in treating COVID-19?

LSALT peptide is designed to prevent organ inflammation associated with COVID-19 complications like ARDS and acute kidney injury.

How will the results of the Phase II trial impact future trials for LSALT peptide?

The results will inform the design of a larger Phase III trial to evaluate efficacy and safety in COVID-19 patients.

What are the potential risks associated with Arch Biopartners' Phase II trial for LSALT peptide?

There is a risk of no significant efficacy being demonstrated in the trial, which could affect future funding and development plans.