TORONTO, ONTARIO–(Marketwired – July 27, 2017) – Arch Biopartners, Inc., (Arch or the Company) (TSX VENTURE:ARCH)(OTCBB:ACHFF) today provided an update on the progress of the good manufacturing practice (GMP) production campaign for AB569, 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.
AB569 is a potential stand alone or complementary treatment to existing and emerging standard of care for COPD and CF patients that have reduced lung function due to Pseudomonas aeruginosa (P. aeruginosa) and other multi-drug resistant bacterial infections in the lung.
P. aeruginosa affects the majority of adult CF patients and often infects patients from childhood onward. Arch has received orphan drug designation in the U.S. for AB569 in the treatment of CF patients with P. aeruginosa lung infections, Arch has also received orphan medicinal product designation in Europe for AB569 for the treatment of CF.
Manufacturing of AB569 on schedule
AB569 is mainly composed of two compounds: Ethylenediaminetetraacetic acid (EDTA) and Sodium Nitrite (NaNO2), which are already approved by the U.S. Food and Drug Administration (FDA) for use in humans in other medical applications.
The GMP manufacturing process and the terminal sterilized glass vial filling campaign for AB569 is being led by Dalton Pharma Services (Dalton) Dalton is preparing glass vials in three varying dose formulations for the clinical kits needed to support the phase I safety trial for AB569 at the Cincinnati Veterans Affairs Medical Center (CVAMC) later this year.
To date, Dalton is on schedule on all aspects of the GMP campaign for AB569. Dalton has successfully completed fill volume studies and tested R&D formulation trials for three bulk batches of EDTA-citrate solution at three different concentrations.
In addition, Dalton has successfully demonstrated the ability to powder fill, using a 100% weight check Mettler-Quantos powder dosing system on three different amounts of sodium nitrite into the required vial container closure system. Terminal sterilization studies on a portion of the EDTA and sodium nitrite vials from the bulk batches are currently ongoing.
Next major manufacturing milestones include an engineering batch for the high concentration EDTA-citrate solution with GMP production batches scheduled by the end of autumn. Additional supporting tasks to be completed in preparation of the vials include analytical method qualifications and sterility validation.
As the GMP campaign nears completion, Arch management intends to provide updates regarding the expected delivery time of the drug product to CVAMC to enable the start of the phase I safety trial.
Upcoming Phase I investigator Initiated Trial
CVAMC will conduct an investigator initiated Phase I human trial 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 AB569 inhalation kits produced by Dalton and other materials to support the trial.
Dr. Pano’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 will transition the AB569 program into a Phase II trial to test the drug treatment’s efficacy in treating chronic P. aeruginosa infections in COPD patients.
Background to AB569 for antibiotic resistant airway infections
AB569 was invented by Dr. Daniel Hassett, Professor at the University of Cincinnati College of Medicine, to treat antibiotic resistant bacterial lung infections, which is a significant problem for patients with either CF or COPD. AB569 is also a candidate treatment for antibiotic resistant urinary tract infections and skin infections. The University of Cincinnati has exclusively licensed AB569 to Arch.
AB569 is a bactericidal compound; and constitutes an innovative potential treatment for dealing with pulmonary bacterial infections, some of which are resistant to all 26 approved antibiotics in the United State alone. In pre-clinical studies, AB569 has demonstrated significant ability to kill many types of Gram-negative and Gram-positive bacteria.
Arch has received orphan drug designation for AB569 from the FDA for the treatment of CF patients with P. aeruginosa infections. Arch has also received an orphan medicinal product designation from the European Medicines Agency for the general treatment of CF patients.
CF patients are predisposed to bacterial lung infections due to abnormal mucus production in the lungs and airways. In particular, Pseudomonas aeruginosa infects 40% of CF patients between the ages of 6 and 10 years of age. By the age of 17, the frequency of infection increases to 60% and reaches approximately 70% of all CF patients between the ages of 25 and 34.
The mucoid form of P. aeruginosa is a very challenging infection to treat due to its high resistance to both antibiotics and phagocyte-mediated killing. Once patients present with the mucoid form of P. aeruginosa, their overall lung function precipitously declines, resulting in a poor overall clinical prognosis.
Likewise, people with COPD have compromised innate immune systems and respiratory conditions that are vulnerable to chronic bacterial infections that are often refractory to conventional antibiotic regimens.
COPD is a major health problem worldwide and its prevalence is increasing (over 325,000,000 patients world-wide), ranked by the World Health Organization as the third leading cause of death. COPD is a general term to describe progressive lung diseases which includes chronic bronchitis, emphysema, and non-reversible asthma. Most cases are caused by inhaling pollutants, predominantly from smoking or exposure to lung pollutants in highly polluted cities around the world as well as the workplace.
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. Dalton brings 30 years of experience to their client’s projects and emphasize quality, speed and flexibility.
Dalton can accelerate a drug development program by integrating process development, cGMP API manufacturing and sterile or solid finished dose manufacturing all at a single location. For Dalton’s full range of in-house services including cGMP sterile fill/finish services please visit www.dalton.com.
CMO 2016 and 2017 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflects Dalton’s ongoing commitment to their clients, peers and the business community. In 2016 Dalton was certified as “A Great Place to Work.”
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
The Company has 54,849,679 common shares outstanding.
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