First Wave BioPharma, Inc. announced that an abstract entitled, Results from an Open-Label, Phase 2 Study with Escalating Doses of Adrulipase Alfa on top of a Stable Dose of Porcine Pancreatic Enzymes (PPE) in CF Patients Not Fully Compensated with PPE as Sole Therapy, has been accepted for a presentation at the 2023 Digestive Disease Week Conference (DDW 2023). The company is currently advancing the Phase 2 SPAN clinicatrial investigating an enhanced enteric microgogranule delivery formulation of adrulipase as a monotherapy for the treatment of exocrine pancreatic insufficiency (EPI) in patients CF. Patient dosing is expected to commence in February with topline results from the study to be available by mid-2023.

Phase 2 Combination Therapy Trial The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially available PERTs. Ideally, a stable daily dose of PERT will enable CF patients to eat a normal to high-fat diet and minimize unpleasant gastrointestinal symptoms. In practice, however, a substantial number of CF patients do not achieve normal absorption of fat with PERTs. Achieving an optimal nutritional status, including normal fat absorption levels, in CF patients is important for maintaining better pulmonary function, physical performance and prolonging survival.

Furthermore, a decline of body mass index around the age of 18 years predicts a substantial drop in lung function. The Phase 2 combination clinical trial was a multi-center study designed to investigate the safety, tolerability and efficacy of escalating doses of adrulipase, in conjunction with a stable dose of PERT, in order to increase the patient's coefficient of fat absorption (CFA) levels and relieve abdominal symptoms. The study enrolled 20 patients, 12 years of age or older, with severe EPI who were treated escalating doses of adrulipase (700mg, 1200mg, and 2240mg) once daily for 15 days per dosing level, in addition to their standard PERT dose. Trial eligibility required a CFA of less than 80%.

The primary efficacy endpoint of the trial was improvement in CFA; secondary endpoints of the study were improvements in the stool weight, stool consistency, number of bowel movements, the incidence of steatorrhea, and increase of body weight.