Arch Biopartners Announces Metablok Achieves Primary Endpoints of Safety and Tolerability in Phase I Trial
TORONTO, Dec. 18, 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) has completed dosing of all scheduled volunteers and Metablok has met the primary endpoints of safety and tolerability. Metablok is the Company’s lead drug candidate for treating organ damage caused by inflammation.
Metablok was well tolerated during the placebo-controlled trial and no drug-related adverse effects were observed in any of the forty-four volunteers, split into five groups. Three of the groups received either a low, medium or high single dose of Metablok and the remaining two groups received a low or medium single daily dose over three days.
Arch is expected to close the trial over the next week with a database lock in early 2020. Final results and study reports will be released over the next 3 months.
During this time, Arch management will begin preparations to engage the U.S. FDA in discussion regarding a New Drug Application and Phase II trial for Metablok.
Metablok Phase I clinical trial
Arch has been conducting the Phase I clinical trial for Metablok with 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.
The successful Phase I trial is expected to be followed by a Phase II trial to investigate Metablok’s efficacy at preventing inflammation related acute kidney injury in patients undergoing cardiac surgery.
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 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 drug library, led by Metablok, to produce new drug candidates that inhibit organ inflammation caused via the DPEP-1 pathway.
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 59,462,302 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: Richard Muruve Chief Executive Officer Arch Biopartners, Inc. 647-428-7031 firstname.lastname@example.org