AzurRx BioPharma Inc (NASDAQ:AZRX)’s CEO – James Sapirstein, and CMO – James, featured in the conference call on March 31, 2021, discussed plans to develop an optimized formulation for MS1819. The company recently concluded option 2 phase 2b clinical study of its drug – MS1819 to treat cystic fibrosis patients suffering from EPI (exocrine pancreatic insufficiency).
Option 2 clinical study of MS1819
The multi-center option 2 clinical studies are designed to evaluate the efficacy, tolerability, and safety of MS1819 compared to the standalone care PERT (porcine enzyme replacement therapy) in curing EPI.
Its primary endpoint is CFA (coefficient of fat absorption). The secondary endpoint is CAN (coefficient of nitrogen absorption), symptoms/ signs of malabsorption, and stool weight.
James said the results of topline option 2 clinical studies are mixed. The safety and tolerability of the new drug is confirmed in the clinical trial. However, its primary objective in the Option 2 trial is not consistently met.
Some patients in the option 2 clinical trial achieved more than the desired CFA, whereas others could not meet the targeted objective. James further said the enteric capsule formulation is responsible for uneven performance in option 2 clinical studies.
The enteric coating on the capsule prevents breakdown in the stomach acids. It also ensures slow dissolving of the capsule in the small intestines for releasing the lipase enzyme at the right time to promote digestion and absorption of nutrients.
Plans to develop new formulation
AzurRx BioPharma plans to devise an innovative formulation of its investigative drug – 1819. The capsule will be filled with microbeads and acid-resistant granules to achieve its desired objectives.
The new capsules will get dissolved easily in the stomach and disperse the beads, passed on through the small intestines and breakdown to release lipase enzyme. Therefore, they will be blended with the food during digestion.
To develop the new formulation, AzurRx BioPharma already held discussions with the contract producers to expedite the process. In Q1 2021, the company already raised $22.5 million to support the new development activities. The fund is also sufficient to evaluate the new formulation’s efficiency in the Phase2 trial next year.
MS1819 will offer compliance, safety, and therapeutic benefits compared to the standard of care available today.