Arch Biopartners Announces Completion of GMP Manufacturing of AB569 and Start Date of Phase I Trial
- Category: Small Molecules
- Published on Wednesday, 06 December 2017 16:59
- Hits: 808
TORONTO, Canada I December 06, 2017 I Arch Biopartners Inc., (Arch or the Company) (TSX Venture:ARCH) (OTCBB:ACHFF) today announced that the good manufacturing practice (GMP) production campaign for AB569 has been completed by Dalton Pharma Services. AB569 is the Company’s inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) patients as well as many other indications.
Clinical kits containing three different dose concentrations of AB569 will be delivered to the Cincinnati Veterans Affairs Medical Center (CVAMC) later this month. The investigator initiated Phase I trial to evaluate the safety and pharmacokinetic profile of AB569 is scheduled to start in early January 2018.
AB569 is a potential stand alone or complementary treatment to existing and emerging standard of care therapies for CF and COPD patients that have reduced lung function due to multi-drug resistant bacterial infections.
AB569 is composed of two compounds: ethylenediaminetetraacetic acid (EDTA) and sodium nitrite, which are already approved by the U.S. Food and Drug Administration (FDA) for use in humans in other medical applications.
Upcoming Phase I Investigator Initiated Trial
CVAMC will conduct an investigator initiated Phase I human trial in twenty-five healthy volunteers to evaluate the safety and pharmacokinetic profile of AB569.
Dr. Ralph Panos, Chief of Medicine at CVAMC and world-renowned COPD expert, is the lead investigator of the trial. Arch is funding the study, contributing the AB569 inhalation clinical drug kits and other materials to support the trial.
Dr. Panos’s clinical team will evaluate single administration of nebulized AB569 in normal participants. The Phase I trial has been designed to determine the pharmacokinetic profile of plasma nitrite and nitrate metabolites, exhaled nitric oxide and circulating hemoglobin after a single inhalation of AB569. In addition, the trial also aims to determine the tolerance of nebulized AB569 in three escalating doses of acidified sodium nitrite and EDTA.
Following the successful completion of the Phase I study, the clinical team at CVAMC in association with the University of Cincinnati College of Medicine will transition the AB569 program into a Phase II trial to test the drug treatment’s efficacy in treating chronic Pseudomonas aeruginosa (P. aeruginosa) infections in COPD patients.
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, other public documents Arch has filed on SEDAR and its technologies including, please visit www.archbiopartners.com
SOURCE: Arch Biopartners