Dalton Pharma Services has entered a drug development and manufacturing agreement with Arch Biopartners, Inc., a Canadian biotechnology firm, to support Arch’s GMP manufacturing campaign for AB569, the company’s inhalation drug candidate for treating antibiotic-resistant bacterial infections in the lungs. Dalton will provide formulation development, cGMP powder and liquid filling, analytical method development and validation, and quality control release testing.
Dalton will be responsible for the GMP preparation and filling of AB569 into glass vials which will form part of the clinical kits required to support the Phase I safety trial for AB569 later this year.
Arch Biopartners has received orphan drug designation for AB569 from the U.S. FDA for treatment of CF patients with Pseudomonas aeruginosa infections, and an orphan medicinal product designation from the EMA for the treatment of CF patients.
“Dalton is privileged to be supporting this critical GMP campaign, and to play an important role in the development of this innovative antibiotic for the treatment of lung infections that affect millions of patients,” said Peter Pekos, chief executive officer and president, Dalton Pharma Services. “The need for a new, effective treatment is very great; some pulmonary bacterial infections are resistant to all 26 antibiotics approved in the United States.”
