TORONTO, Oct. 29, 2018 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH and OTCQB: ACHFF) today provided an update on the general results from toxicology and pharmacology studies evaluating Metablok, the Company’s lead drug candidate for treating acute kidney injury.
In seven day studies involving rodents and another larger animal species, there were no significant drug-related side effects in the toxicology assessments.
These studies provide the primary safety data to support the Phase I human safety trial for Metablok expected to begin in early 2019. This will be followed by a Phase II trial to test Metablok’s efficacy in the prevention of acute kidney injury in cardiac surgery patients.
The pharmacokinetic results from each toxicology study demonstrated that intravenous administration of Metablok resulted in minimal to no side effects after the infusion period. In addition, the bioavailability and pharmacokinetics observed in both species are expected to support future intravenous (I.V.) administration in patients at multiple dose levels once or twice daily for up to seven days.
Nucro-Technics is currently completing the 14-day toxicology and pharmacology studies in both species and results so far indicate there continues to be no significant side effects.
“As we finish our pre-clinical toxicology and pharmacology studies, the positive results indicate that our initial clinical trial design of multiple I.V. doses of Metablok over a period of a few days is both feasible and appropriate and can be assessed in a single Phase I human trial,” said Dr. Daniel Muruve, Chief Science Officer of Arch and Chief of Nephrology in southern Alberta.
Arch management continues to prepare for the phase I trial for Metablok and will make further disclosures in coming weeks regarding a confirmed clinical site and start date.
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 mortality, complications in treatment course, and higher risk of complications such as cardiovascular events and infection. Of the patients that require dialysis because of cardiac surgery-associated AKI, many will require lifelong dialysis which increases overall morbidity and mortality.
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 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 now has 58,495,179 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.
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