Arch Biopartners Expands Dosing in Phase I Trial for Metablok to Increase Dose Range for Future Phase II Studies
TORONTO, March 04, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that it is expanding the dose range of Metablok (LSALT peptide) for future Phase II trials targeting inflammation in the lung, the kidney and/or the liver by adding a cohort of eight healthy volunteers to receive the highest daily dose tested to date for three consecutive days.
Metablok is the Company’s lead drug candidate for treating organ damage caused by inflammation.
The three-day dosing of the additional eight volunteers will provide Arch supplemental dosing data, for review by the U.S. FDA, for its future Phase II trials. The expanded trial will allow an option of a higher dose of Metablok to potentially prevent or treat organ inflammation.
Dosing of the eight additional volunteers has begun and dosing is expected to end during March 2020.
The additional cohort of eight people has been added based on the successful dosing and safety of Metablok in the first 44 volunteers. To date, participants have received up to a high single dose of Metablok, or a low or medium daily dose over three days. In all cases, Metablok was well tolerated during the placebo-controlled trial and no drug-related adverse effects were observed.
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.
Metablok is an inflammation targeting drug and a potential therapeutic agent to prevent organ injury caused by sepsis and ischemia reperfusion injury. Metablok targets a novel neutrophil (white blood cell) adhesion molecule discovered by Arch scientists and reported in the journal Cell in September 2019.
A successful Phase I trial is expected to be followed by a Phase II trial to investigate Metablok’s efficacy at preventing inflammation in a vital organ. Arch is considering targeting inflammation related acute kidney injury in patients undergoing cardiac surgery as a first Phase II indication and/or a separate trial to target inflammation in the lungs caused by infection.
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 59,882,302 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 MuruveChief Executive OfficerArch Biopartners, Inc. 647-428-7031