Friday, July 14, 2023
First Wave BioPharma, Inc. (NASDAQ:FWBI) has recently released the topline results from its Phase 2 SPAN clinical trial. The trial aimed to evaluate the efficacy, safety, and tolerability of an enhanced enteric microgranule delivery formulation of adrulipase for the treatment of exocrine pancreatic insufficiency (EPI) in cystic fibrosis (CF) patients. The initial data suggests that the enhanced formulation of adrulipase was well tolerated and demonstrated improved results compared to previous formulations. However, it appears that the primary efficacy endpoint may not have been achieved. The company is currently analyzing the data and plans to provide additional findings on the primary and secondary endpoints within approximately eight weeks.
The Phase 2 SPAN clinical trial included thirteen patients and focused on assessing the enteric microgranule delivery formulation of adrulipase. The primary efficacy endpoint was the coefficient of fat absorption (CFA), while secondary endpoints included stool weight, signs and symptoms of malabsorption, and coefficient of nitrogen absorption (CNA).
Based on the initial safety and efficacy results, First Wave BioPharma intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review the data and discuss the parameters for a Phase 3 clinical trial that would meet the requirements for a Biologics License Application (BLA). The company expects to hold the End-of-Phase 2 meeting in the fourth quarter of 2023.
James Sapirstein, the President and CEO of First Wave BioPharma, expressed that the preliminary data from the Phase 2 SPAN clinical trial showed that the enhanced microgranule delivery formulation of adrulipase was well tolerated. The company is currently analyzing the dataset and anticipates providing a comprehensive review of the primary and secondary endpoints in September. Sapirstein also expressed gratitude to the patients who participated in the study and acknowledged the efforts of the investigators and clinical trial staff at the participating sites in ensuring the trial's successful completion.
Adrulipase is an oral, non-systemic biologic capsule containing a recombinant lipase enzyme. It is designed to treat exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) and chronic pancreatitis (CP). Adrulipase, derived from the Yarrowia lipolytica yeast lipase, aids in breaking down fat molecules in the digestive tract of EPI patients, facilitating their absorption as nutrients. EPI is a condition characterized by a deficiency in exocrine pancreatic enzymes, leading to impaired food digestion and maldigestion symptoms such as greasy diarrhea, fecal urge, and weight loss. According to estimates from the Cystic Fibrosis Foundation and the National Pancreas Foundation, there are approximately 40,000 EPI patients caused by cystic fibrosis and 95,000 patients caused by chronic pancreatitis in the United States.