Arch Biopartners Receives Approval from Turkish Ministry of Health to Proceed with Phase II Trial for LSALT Peptide; Begins Screening Patients in Florida
Arch Biopartners Inc. (OTCQB: ACHFF) has received approval from Turkey's Ministry of Health to proceed with a Phase II trial for its LSALT peptide drug, targeting acute lung and kidney injuries related to COVID-19. Patient enrollment will commence in Istanbul and Ankara, amidst rising COVID-19 cases in Turkey. In the U.S., patient screening has begun at a hospital site in Florida, with plans to activate two more sites. The trial aims to assess the LSALT peptide's efficacy in preventing organ inflammation in COVID-19 patients, impacting future Phase III study designs.
- Approval for Phase II trial in Turkey enhances drug development prospects for LSALT peptide targeting COVID-19-related complications.
- Patient enrollment will begin shortly in Turkey, indicating swift progress in clinical trials.
- Initial patient screening is underway in the U.S., expanding the trial's geographic scope.
- The rising COVID-19 cases in Turkey, with over 1,500 new daily infections, may impact patient recruitment and healthcare resources.
- High hospitalization rates in Turkey could strain the trial's operational capacities.
TORONTO, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the Ministry of Health to proceed with 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 moderate to severe cases of COVID-19.
Activation of clinical sites in Istanbul and Ankara and patient enrollment into the trial will begin imminently in Turkey, where COVID-19 infection rates continue to be in the range of 1,500 new cases per day. Since early September, new COVID-19 hospitalizations continue to strain the Turkish medical system and there have been over 2,100 deaths.
In the United States, patient screening has begun at the study’s first hospital site in Florida. Arch Biopartners continues to prepare the activation of two additional U.S. sites into the Phase II trial.
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 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).
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 and kidneys.
The Phase II results will be used to design the Phase III trial, including greater patient numbers to more fully evaluate efficacy and safety in COVID patients.
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 approved vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of severe COVID-19 has been primarily supportive, relying heavily on respiratory, infectious disease 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-2.
1 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.
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 60,782,302 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
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