TORONTO, Dec. 11, 2018 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH and OTCQB: ACHFF) today announced it has formed a 100% owned subsidiary in Australia, named Arch Clinical Pty Ltd, to pursue an application to perform a phase I safety trial in Australia for Metablok, the Company’s lead drug candidate for treating acute kidney injury.
The Arch team has started the human trial application process with the Alfred Health Human Research Ethics Committee (HREC). The draft application was accepted for registration on December 10, 2018 and will be followed by the full submission and review in early January 2019. A decision regarding trial approval is expected before February 2019.
The Phase I study will be a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of Metablok (LSALT Peptide) in healthy participants. A successful Phase I trial will be followed by a Phase II trial to investigate Metablok’s efficacy in the prevention of acute kidney injury in cardiac surgery patients.
About Metablok (LSALT peptide)
Metablok (renamed “LSALT peptide” in Arch 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.
Cardiac Surgery-Associated Acute Kidney Injury
Acute kidney injury (AKI) occurs in approximately 30% of patients that undergo cardiac bypass surgery with 1% of patients requiring dialysis. Currently, no specific therapies exist to prevent AKI. Worldwide, there are over one million patients per year that have cardiac surgery procedures.
AKI represents an additional challenge in patients recovering from cardiac surgery as they have higher incidences of treatment-related complications, and increased risk of cardiovascular events, infection and death. Of the patients that require dialysis because of cardiac surgery-associated AKI, many will require lifelong therapy.
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.
Recent Corporate Developments
The Company has accepted the exercise of 20,0000 common share purchase warrants resulting in the issuance of 20,000 new common shares. The warrants had an exercise price of $0.50 and were issued in August 2017. These warrants were exercised by an arm’s length party.
The Company also announced today that it settled an annual interest payment owing to the arm’s length holder of an unsecured, delayed convertible note disclosed to the market in a press release dated October 23, 2017. The interest payment of $25,000 was settled by issuance of 17,123 common shares at a share price of $1.46 per share. This shares-for-debt settlement has received conditional approval from the TSX Venture Exchange.
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 includes Metablok, a potential treatment for inflammation, sepsis and cancer metastasis; AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung, urinary tract 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 58,515,179 common shares outstanding.
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.
For more information, please contact:
Chief Executive Officer
Arch Biopartners, Inc.