Description:

FW-EPI (adrulipase) is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients.

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss. There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation.

The digestive standard of care for both CF and CP patients with EPI are commercially-available pancreatic enzyme replacement therapy (PERT) pills, which are made from the pancreases of pigs. However, a substantial number of patients do not achieve normal absorption of fat with PERTs. Moreover, PERTs require the administration of as many as 40 pills per day and have potential issues with Black Box safety warnings due to the animal sourcing.

In developing adrulipase, Entero Therapeutics is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived, offers the potential to dramatically reduce their daily pill burden, and can be manufactured on demand at high volumes safely and with a high degree of reproducibility.

Entero Therapeutics is developing adrulipase as a monotherapy and in combination with PERT. Entero Therapeutics expects to initiate a Phase 2 clinical trial by mid-2022 to investigate an enhanced formulation of adrulipase as a monotherapy for the treatment of EPI.

Description:

FW-EPI (adrulipase) is a recombinant lipase enzyme administered as an oral, non-systemic biologic capsule for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase is derived from the Yarrowia lipolytica yeast lipase and is designed to break up fat molecules in the digestive tract of EPI patients so that they can be absorbed as nutrients.

EPI is a condition characterized by deficiency of the exocrine pancreatic enzymes, resulting in a patient’s inability to digest food properly, or maldigestion. The deficiency in this enzyme can be responsible for greasy diarrhea, fecal urge and weight loss. There are more than 30,000 patients in the U.S. with EPI caused by cystic fibrosis according to the Cystic Fibrosis Foundation and approximately 90,000 patients in the U.S. with EPI caused by chronic pancreatitis according to the National Pancreas Foundation.

The digestive standard of care for both CF and CP patients with EPI are commercially-available pancreatic enzyme replacement therapy (PERT) pills, which are made from the pancreases of pigs. However, a substantial number of patients do not achieve normal absorption of fat with PERTs. Moreover, PERTs require the administration of as many as 40 pills per day and have potential issues with Black Box safety warnings due to the animal sourcing.

In developing adrulipase, Entero Therapeutics is seeking to provide CF and CP patients with a safe and effective therapy to control EPI that is non-animal derived, offers the potential to dramatically reduce their daily pill burden, and can be manufactured on demand at high volumes safely and with a high degree of reproducibility.

Entero Therapeutics is developing adrulipase as a monotherapy and in combination with PERT. Entero Therapeutics recently reported results from its Phase 2 clinical trial of adrulipase in combination with PERT. Data demonstrated a meaningful improvement in coefficient of fat absorption (CFA), suggesting that that combination therapy may benefit CF patients with severe EPI.