Delpharm will manufacture AzurRx’s MS1819 cGMP batch that will be used in the Phase 2b OPTION 2 Clinical Trial for the treatment of EPI in patients with Cystic Fibrosis (CF). As preparation for the cGMP batch, the drug product manufacturing process was transferred to Delpharm and they have successfully produced a non-GMP batch. This marks the first time in which MS1819 has been manufactured with enteric capsules, which will be used in the OPTION 2 Trial to deliver MS1819 drug product during the duodenal phase of digestion.
“We are very pleased to have Delpharm continue to be our MS1819 manufacturing partner as we prepare for the launch of our OPTION 2 Clinical Trial,” said James Sapirstein, chief executive officer, AzurRx BioPharma. “We greatly appreciate Delpharm’s commitment to continue working through the COVID-19 pandemic to produce our clinical study drug product, which will enable us to meet our planned timelines and initiate the study in Q2 2020, as expected.”
Sébastien Aguettant, chief executive officer, Delpharm, said, “Delpharm is very proud to play a role in supporting AzurRx’s clinical trial and helping cystic fibrosis patients gain access to this promising new treatment.”