TORONTO, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the Phase I human trial of Metablok (LSALT peptide), the Company’s lead drug candidate for treating organ damage caused by inflammation, has met the primary endpoints of safety and tolerability in the trial’s three single ascending dose cohorts of healthy volunteers.
To date, twenty-eight of forty-four planned volunteers for the trial have received either a low, medium or high single dose and no adverse effects were observed post-dosing.
Consequently, testing Metablok in 3-day, multiple ascending dose cohorts of eight volunteers per cohort has already begun. This second part of the study, representing the expected dosing schedule for the Phase II trial, is expected to be completed by the end of November. At that time, Arch plans to provide a further update.
Metablok Phase I clinical trial
Arch has been conducting the Phase I clinical trial for Metablok with 44 healthy volunteers in Melbourne, Australia. The Phase I trial is a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of Metablok.
A successful Phase I trial is expected to be followed by a Phase II trial to investigate Metablok’s efficacy in a 3-day treatment regime aimed at preventing inflammation-related acute kidney injury in cardiac surgery patients.
Cardiac Surgery-Associated Acute Kidney Injury
Acute kidney injury (AKI) represents an additional challenge for patients recovering from cardiac surgery. AKI occurs in approximately 30% of patients that undergo cardiac bypass surgery with approximately 5-7% of patients requiring dialysis. For patients who recover from the need for dialysis or mild AKI, there is a greater likelihood of developing chronic kidney disease in future than those who did not have AKI.
Currently, no specific therapies exist to prevent AKI. Worldwide, there are over one million patients per year that have cardiac surgery procedures.
Inflammation is known to contribute to AKI related to ischemia-reperfusion and other insults to the kidney that may occur in the course of cardiac surgery.
Metablok is a novel therapeutic agent that may protect the kidneys and prevent AKI in patients undergoing cardiac surgery.
About Metablok
Metablok (referred to as “LSALT peptide” in science publication and communications with the U.S. FDA) is a novel peptide drug candidate in the Arch development pipeline and a potential treatment for the following highly problematic indications: (i) inflammation, (ii) sepsis and (iii) cancer metastasis.
Other Corporate Developments
The Company also announced today that a total of 40,000 warrants to buy common shares at $0.50 and held by non-insiders were recently exercised for net proceeds of $20,000. As a result of this warrant exercise, there currently are no outstanding warrants to purchase common shares of Arch.
The Company also announced today that certain directors of the Company and a non-insider consultant recently exercised a total of 150,000 stock options to buy 150,000 common shares of the Company for proceeds of $45,000.
About Arch Biopartners
Arch Biopartners Inc. is focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch has established a diverse portfolio that is led by Metablok, a potential treatment for inflammation, sepsis and cancer metastasis.
Continuing under development in the Arch portfolio is AB569, a potential new treatment for antibiotic resistant bacterial infections in the lungs or wounds, 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 59,112,302 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.
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.