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30 Jul 2017

Arch Biopartners' GMP manufacturing of AB569 on schedule

Dalton Pharma Services 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 CVAMC later this year.

Arch Biopartners has 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.

Arch has received orphan drug designation in the US for AB569 in the treatment of CF patients with P. aeruginosa lung infections, and 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 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, who 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.

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