Arch Biopartners Granted Pre-Ind Meeting With FDA for Candidate Drug to Prevent Acute Kidney Injury
TORONTO, March 21, 2018 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (Arch or the Company) (TSX Venture:ARCH) (OTCBB:ACHFF), announced today that a Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products (DCRP) will take place on April 18, 2018 to review and confirm the key components of a planned IND application for Metablok (LSALT peptide) as a treatment to prevent acute kidney injury.
The first target indication for Metablok is the prevention of acute kidney injury that commonly occurs in patients during cardiac surgery. Currently, there are no specific treatments for the prevention of acute kidney injury.
The Pre-IND meeting will provide the Arch team with an opportunity to discuss and confirm with the FDA the planned content of an IND application for Metablok. An IND application is a request to the FDA for authorization to administer a new drug to patients in a human trial.
In advance of the Pre-IND meeting, the Arch team submitted an information package to the FDA DCRP containing questions and draft IND application content in the areas of toxicology; chemistry; manufacturing; phase I study protocol; and a pathway for future regulatory milestones.
Metablok (renamed “LSALT peptide” in Arch communications with 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.
Inflammation and Acute Kidney Injury:
Inflammation is a localized physical condition that involves the activation of the immune system in response to infection, tissue injury, or autoimmunity. Inflammation is involved in the pathogenesis of many diseases and plays a significant role in acute kidney injury. Acute kidney injury due to ischemia/reperfusion occurs in up to 30% of patients undergoing cardiovascular and other major surgeries.
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 works closely with the scientific community, universities and research institutions to advance and build the value of select preclinical technologies, develop the most promising intellectual property, and create value for its investors.
Arch has established a diverse portfolio that includes AB569, a potential new treatment for antibiotic resistant bacterial infections; Metablok, a potential treatment for inflammation, sepsis and cancer metastasis; MetaMx, which targets elusive brain tumor initiating cells; and, ‘Borg’ peptide coatings that increase corrosion resistance and decrease 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 57,799,679 common shares outstanding.
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