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Today, ARCH Biopartners Inc., ("ARCH" or the "Company") (TSX Venture: ARCH and OTCQB: ACHFF), a clinical stage company focused on the development of novel therapeutics targeting organ inflammation, announced that it has safely increased the maximum daily dose of LSALT peptide to 20 mg per day in healthy, normal volunteers in a recently completed human trial in Australia.
LSALT peptide is the Company's lead drug candidate for treating inflammation in the lungs, liver and kidneys and Arch intends to use the new maximum dose in designing a Phase II trial targeting cardiac surgery-associated acute kidney injury (CS-AKI). The new safety data will be included in an Investigational New Drug Application to the U.S. FDA, to be submitted in relation to the CS-AKI trial in due course.
Prior to this dose escalation trial, LSALT peptide was administered at a maximum of 5mg once daily, for up to 14 days, in hospitalized COVID-19 patients during a Phase II trial targeting inflammation in the lungs.
Dose Escalation Trial
The dose escalation human trial was performed at the Alfred Hospital in Melbourne, Australia. The trial was a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of LSALT peptide. Sixteen healthy, normal volunteers participated, receiving either LSALT peptide or a placebo, and were divided into two groups.
Six participants in each group received a daily dosing of LSALT peptide for one day followed by three consecutive days of dosing. Two people per group received a placebo with the same dosing schedule. In the first group, six people received a once daily, 10 mg intravenous (IV) dose of LSALT peptide. In the second group, six volunteers received a 10 mg IV dose of LSALT peptide twice a day, approximately every 12 hours.
In both groups, LSALT peptide met the primary endpoints of safety and tolerability.
LSALT Peptide Drug Product Manufacturing Update
During the last few months, Arch has continued to advance the production of new supply of LSALT peptide to be used in non-Covid human trials. The production of approximately 10,000 LSALT peptide drug product vials has recently been completed. The new vials are undergoing quality control and quality assurance procedures at the Company's third-party manufacturing facility in Toronto, Canada. The drug product vials contain approximately 5mg of LSALT peptide and are expected to be released to Arch in May 2023.
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 Biopartners is developing a pipeline of new drug candidates that inhibit inflammation in the lungs, kidneys and liver via the dipeptidase-1 (DPEP-1) pathway, relevant for multiple medical indications.
For more information on Arch Biopartner's science and technologies, please visit: www.archbiopartners.com/our-science
For investor information and other public documents the company has also filed on SEDAR, please visit www.archbiopartners.com/investor-hub
The Company has 62,398,825 common shares outstanding.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable Canadian securities laws regarding expectations of our future performance, liquidity and capital resources, as well as the ongoing clinical development of our drug candidates targeting the dipeptidase-1 (DPEP-1) pathway, including the outcome of our clinical trials relating to LSALT Peptide (Metablok), the successful commercialization and marketing of our drug candidates, whether we will receive, and the timing and costs of obtaining, regulatory approvals in Canada, the United States, Europe and other countries, our ability to raise capital to fund our business plans, the efficacy of our drug candidates compared to the drug candidates developed by our competitors, our ability to retain and attract key management personnel, and the breadth of, and our ability to protect, our intellectual property portfolio. These statements are based on management's current expectations and beliefs, including certain factors and assumptions, as described in our most recent annual audited financial statements and related management discussion and analysis under the heading "Business Risks and Uncertainties". As a result of these risks and uncertainties, or other unknown risks and uncertainties, our actual results may differ materially from those contained in any forward-looking statements. The words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We undertake no obligation to update forward-looking statements, except as required by law. Additional information relating to Arch Biopartners Inc., including our most recent annual audited financial statements, is available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval ("SEDAR") website at www.sedar.com .
The science and medical contents of this release have been approved by the Company's Chief Science Officer.
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
