Arch Biopartners to Seek Regulatory Guidance From the U.S FDA for AB569
TORONTO, June 19, 2018 (GLOBE NEWSWIRE) -- Arch Biopartners, Inc., (Arch or the Company) (TSX-V:ARCH) (OTCBB:ACHFF) a portfolio-based biotechnology company, today announced that it will seek regulatory guidance from the U.S.
Food and Drug Administration (FDA) in a pre-Investigational New Drug application meeting (pre-IND meeting) for AB569, the company’s drug candidate for treating antibiotic resistant bacterial infections in the lungs, wounds and urinary tract.
Arch began sponsoring an investigator initiated phase I study testing the safety of inhaled AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) earlier this year. “We have decided with our clinical team that this is the best time to initiate dialogue with the FDA and complete the phase I study under an open IND application. Since our ultimate goal is to obtain drug approval and treat patients who are battling antibiotic resistant bacterial infections, starting the regulatory process now will help us make the most of our resources and avoid having to repeat a phase I trial for the FDA,” said Richard Muruve, CEO of Arch Biopartners.
The investigator-initiated phase I safety trial will thus be on hold and will resume again after the IND application is opened and the FDA approves the phase I study. So far, the data accumulated from the investigator initiated study at the CVAMC are insufficient at this time to make a reliable disclosure regarding the safety of AB569.
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 AB569, a potential new treatment for antibiotic resistant bacterial infections in the lung, urinary tract or wounds; Metablok (LSALT peptide), a potential treatment for inflammation, sepsis and cancer metastasis; 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 57,905,179 common shares outstanding.
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