Patrys Limited announced its Contract Development Manufacturing Organization (CDMO) has successfully completed specification testing of PAT-DX1 drug substance produced in the recently-completed engineering run. As anticipated, the GMP material produced has passed all specification requirements and can now be used to complete remaining pre- clinical toxicology studies in preparation for a phase 1 clinical trial of PAT-DX1 that is planned to commence in H2 CY2023. Specification, or batch release, testing is a necessary requirement to ensure high quality pharmaceuticals are used in GMP and clinical studies.

A wide range of analytical tests are conducted to analyse the physical characteristics of the drug substance and to ensure that the activity and purity of the drug material fall within pre-defined tolerance levels. The PAT-DX1 drug material has also undergone microbiological and chemical testing to verify the absence of contaminants. This GMP PAT-DX1 drug material will be used to complete the two remaining animal toxicology studies that are required before first-in-man studies can be initiated.

Patrys has already successfully completed animal toxicology studies using non-GLP PAT-DX1 drug material and these showed that it is safe and well-tolerated. No mortalities or antibody-related changes in body weight, hematology or clinical chemistry were observed in these studies which were conducted in two different animal species (rodents and primates). These data have been used to inform the design of GLP toxicology studies for PAT-DX1 which are scheduled to commence in Fourth Quarter CY2022.