Turkish Ministry of Health Approves Increase in Patient Recruitment into the Phase II Trial for LSALT Peptide

Rhea-AI Summary

Arch Biopartners Inc. (OTCQB: ACHFF) received approval from the Turkish Ministry of Health to double patient recruitment for its Phase II trial of LSALT peptide (Metablok), targeting acute lung and kidney injuries linked to severe COVID-19 cases. The trial now allows for 40 patients in Turkey, with the first 20 having completed treatment. The ongoing surge in COVID-19 cases in Turkey, exceeding 32,000 daily infections, emphasizes the trial's urgency. As of now, 46 patients have been recruited across North America and Turkey, aiming to demonstrate Metablok's efficacy in preventing organ inflammation.

Positive

• Turkish Ministry of Health approved an increase in patient recruitment from 20 to 40 for the Phase II trial of LSALT peptide.
• First 20 patients in Turkey have completed treatment, indicating progress in the trial.
• The trial's approval comes at a critical time with a surge in COVID-19 cases in Turkey, highlighting the drug's potential relevance.

Negative

• The rising number of COVID-19 infections in Turkey may indicate a worsening public health crisis, which could complicate conducting trials.
• Currently, only 46 patients have been recruited out of the targeted 60 for the Phase II trial, suggesting recruitment challenges.

TORONTO, March 30, 2021 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval from the Turkish Ministry of Health, Pharmaceuticals and Medical Devices Agency (MoH) to recruit up to twenty additional patients into the Phase II trial of its lead drug LSALT peptide (Metablok), targeting acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19.

The approval from the MoH doubles the number of patients allowed into the Turkish arm of the trial from twenty to forty. The first twenty patients in Turkey have already been recruited into the trial and have completed treatment. Patient recruitment is expected to resume this week in two hospital sites in Istanbul and Ankara.

Recent data have shown a second surge in new COVID-19 infections and hospitalizations in Turkey, with a new pandemic high of over 32,000 daily infections reported on March 29, 2021. Turkey experienced a similar surge in daily infections during December 2020. Hospitalization rates are currently at approximately 1% of infected cases, once again putting a strain on the Turkish hospital system.  

Patient recruitment in this 60-patient phase II trial continues in four clinical sites in Canada and the USA, with 46 patients recruited to date between North America and Turkey.

“We appreciate the support of the Turkish Ministry of Health and the enthusiasm of our clinical sites in Turkey to recruit more patients into our trial during this difficult pandemic,” said Richard Muruve, CEO of Arch.

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 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

FAQ

What recent approval did Arch Biopartners receive regarding its Phase II trial?

Arch Biopartners received Turkish Ministry of Health approval to increase patient recruitment for its Phase II trial of LSALT peptide from 20 to 40 patients.

How many patients have been recruited for the LSALT peptide trial so far?

As of now, a total of 46 patients have been recruited across North America and Turkey for the LSALT peptide Phase II trial.

What is the goal of the Phase II trial for LSALT peptide?

The Phase II trial aims to evaluate the LSALT peptide's effectiveness in preventing acute lung and kidney injuries caused by severe COVID-19 infections.

How has the COVID-19 situation in Turkey affected Arch Biopartners’ trial?

The recent surge in COVID-19 cases in Turkey, exceeding 32,000 daily infections, underscores the urgency and potential relevance of Arch Biopartners’ LSALT peptide trial.

What is the stock symbol for Arch Biopartners?

The stock symbol for Arch Biopartners is ACHFF, traded on the OTCQB.