Arch Biopartners Forms New Subsidiary to Pursue a Phase I Trial in Australia for Metablok (LSALT Peptide)
12 December 2018 - 12:02AM
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.
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.
For more information, please contact:
Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc.
647-428-7031
info@archbiopartners.com
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