Patrys Ltd (ASX:PAB) has ticked all the right boxes during an engineering run for its PAT-DX1 drug candidate.
The therapeutic antibody developer recently launched a specification test for PAT-DX1, which ensures high-quality pharmaceuticals are used in good manufacturing practice (GMP) and clinical studies.
Promisingly, PAT-DX1 met all necessary requirements during the run, meaning the material produced can be used to complete any remaining preclinical toxicology studies.
Big picture, Patrys is putting in the groundwork ahead of a Phase 1 clinical trial, which is slated to kick off in the second half of next year.
“On a solid trajectory”
Speaking to the engineering run’s success, Patrys’ vice president of research and development Valentina Dubljevic said: “Our contract development manufacturing organisation has worked tirelessly throughout this process to ensure a successful outcome.
“This has been the result of an effective collaborative process with our specialist manufacturing consultant and in-house team.”
Patrys' CEO and managing director Dr James Campbell echoed her comments: “We are very pleased to have developed and refined a manufacturing process for PAT-DX1 that puts us on a solid trajectory to initiate the planned Phase 1 clinical trial.
“We are delighted that this improved process has provided us with both GMP-quality material that has met specification and has also improved the yield.
“Given the positive safety and tolerability profile we have seen with PAT-DX1 to date, we remain confident that the remaining animal toxicology studies will support the advancement of PAT-DX1 into the clinic next year.”
What are specification tests?
Specification (also known as batch release) testing serves as a pharmaceutical litmus test, making sure only quality drugs make it to the manufacturing and clinical phases.
Essentially, scientists conduct a wide range of analytical tests to analyse the physical characteristics of the drug, making sure that the activity and purity falls within pre-defined tolerance levels.
PAT-DX1 has also undergone microbiological and chemical testing to verify the absence of contaminants, and the resulting GMP material will be used to complete the two remaining animal toxicology studies before first-in-human studies can begin.
Patrys has already completed animal toxicology studies using non-GMP PAT-DX1 drug material and these showed that it is safe and well-tolerated.
This means 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).
The data have informed the design of toxicology studies for PAT-DX1, which are scheduled to kick off next quarter.