Arch Biopartners Receives Health Canada Authorization to Amend Phase II Trial Protocol for LSALT Peptide
Arch Biopartners Inc. (ACHFF) has received a No Objection Letter from Health Canada regarding protocol amendments for its Phase II trial of LSALT peptide (Metablok), which targets organ inflammation in severe COVID-19 cases. Changes include lowering the minimum patient age from 45 to 18 and simplifying the treatment regimen. These modifications aim to enhance enrollment and patient care in the study. The amended protocol will be submitted to the U.S. FDA and Turkish Ministry of Health. The trial is crucial for evaluating Metablok's effectiveness against acute lung and kidney injuries in COVID-19 patients.
- Health Canada approved protocol amendments, enhancing patient eligibility and study execution.
- The trial design is now patient-friendly, potentially increasing enrollment.
- None.
TORONTO, March 16, 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 preventing organ inflammation, announced today that Health Canada has provided a No Objection Letter for the Company’s protocol amendments for 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 protocol amendments were recommended by clinical investigators and key medical advisors assisting with the study and were based on information gathered to date from the first 45 patients recruited into the Phase II trial. The changes to the protocol were designed to facilitate enrollment and execution of the sixty-patient study, improve patient care for those undergoing treatment and to broaden patient eligibility to receive Metablok.
The amendments approved by Health Canada include the lowering of the minimum age of patients admissible into the trial to 18 years from 45 and a simplified treatment regimen including the reduction in daily blood draws based on the safety profile observed in prior patients.
The amended protocol has now been distributed to the two clinical sites currently active in Calgary, Canada and will be adopted by the Canadian clinical teams following local internal review board approval. The amended protocol will also be submitted to the U.S. FDA, as well as the Turkish Ministry of Health, with adoption by the participating clinical sites in the USA and Turkey as soon as possible.
“We appreciate the rapid review and approval of the protocol amendment by Health Canada. The amended protocol will broaden the patient base and simplify our Phase II trial for Metablok. We look forward to the approval of the amendment by the respective ethic committees to make our trial more patient friendly, less labour intensive and more inclusive for a wider range of patients,” 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
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. Currently, no effective antiviral drug or specific treatment exists for SARS-CoV-2 infection. 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, the lungs and urinary tract; 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, following the exercise of 100,000 stock options by an arms-length consultant to the Company for proceeds of
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
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