Arch Biopartners Safely Completes Expanded Dosing of METABLOK in Phase I Human Trial and Begins Focus on Phase II Trial
TORONTO, March 17, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that it has safely completed dosing of the final eight healthy volunteers in its Phase I human trial of Metablok (LSALT peptide). This final group received the highest daily dose of Metablok tested to date for three consecutive days and met the primary endpoints of safety and tolerability.
Metablok is the Company’s lead drug candidate for treating inflammation in the lungs, liver and kidneys.
The completion of the Phase I trial can now be followed by Phase II studies to investigate Metablok’s efficacy at preventing inflammation in a vital organ. Arch has been considering targeting inflammation related acute kidney injury in patients undergoing cardiac surgery and/or a separate trial to target inflammation in the lungs caused by infection. However, given the urgent world need at present, Arch is exploring the possibility of accelerating the use of Metablok in a Phase II trial to target inflammation in the lungs caused by viral pneumonia and help reduce related mortality.
In the worst cases of COVID-19 infection, patients generally die because of severe lung inflammation due to viral pneumonia, and subsequent respiratory failure.
“Our Phase I trial shows the drug was well tolerated and we are ready to pursue further clinical testing in a Phase II trial. In the absence of a vaccine for all to prevent COVID-19 infection, Arch will look for opportunities to explore the possible role of Metablok as a viable treatment option for COVID-19 infected patients to help reduce lung inflammation and to increase survival rates,” said Richard Muruve, CEO of Arch.
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 was a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of Metablok.
A total of 52 healthy, normal volunteers received dosing of Metablok during the Phase I study. All participants received either a low, medium or high dose of Metablok, either as a one-time dose or a daily dose over three days. In all cases, Metablok was well tolerated during the placebo-controlled trial and no significant drug-related adverse effects were observed.
Arch is expected to close the trial over the next few weeks with a database lock in April 2020. Final results and study reports will be released from the clinical site to Arch over the next three months.
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 to produce new drug candidates that inhibit inflammation in the lungs, liver and kidneys caused via the dipeptidase-1 (DPEP-1) pathway.
Metablok is a novel peptide drug candidate and the lead DPEP-1 inhibitor in the Arch development pipeline. A scientific team led by Arch scientists Dr. Donna Senger and Dr. Stephen Robbins recently published a paper in the journal Cell describing a novel mechanism of action for organ inflammation. In the publication, DPEP-1 was identified for the first time as a major neutrophil (white blood cell) adhesion receptor on the lung, liver and kidney endothelium.
Continuing under development in the Arch portfolio are: AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung and 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 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