AzurRx BioPharma to Present Interim Phase 2 Clinical Study Data for MS1819-SD, in Combination with Standard Pert for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency, At Biotech Showcase 2020 Conference (January 13) in San Francisco
January 10, 2020 at 12:22 am
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AzurRx BioPharma, Inc. announced it will present new data from five patients enrolled in its Phase 2 study for its lead development candidate MS1819-SD at the 2020 Biotech Showcase Conference being held at the Hilton San Francisco Union Square Hotel (Yosemite C - Ballroom Level) on January 13th at 3:00 p.m. Pacific Time. The Phase 2 clinical trial is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, in conjunction with a stable dose of PERTs, in order to increase the coefficient of fat absorption (CFA) and relieve abdominal symptoms in Cystic Fibrosis (CF) patients suffering from severe exocrine pancreatic insufficiency (EPI). Patients enrolled in the study continue to experience clinical symptoms of fat malabsorption, despite efforts to control their symptoms with commercially-available PERTs. Data from the initial five patients showed positive trends regarding the primary efficacy endpoint of CFA improvement with no adverse events reported. Trends were also positive in the secondary endpoints of improvements in body weight and stool consistency and reductions in the number of bowel movements and the incidence of steatorrhea. Additionally, multiple patients reported experiencing less abdominal pain while being on the combination therapy. 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 multi-center study is designed to investigate the safety, tolerability and efficacy of escalating doses of MS1819-SD, in conjunction with a stable dose of PERTs, in order to increase the patient’s CFA levels and relieve abdominal symptoms. A combination therapy of PERT and MS1819-SD has the potential to: correct macronutrient and micronutrient maldigestion; eliminate abdominal symptoms attributable to maldigestion; and sustain optimal nutritional status on a normal diet in CF patients with severe EPI. Planned enrollment is expected to include approximately 24 CF patients with severe EPI, with study completion anticipated in 2020.
First Wave BioPharma, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (GI) diseases. It is focused on developing a therapeutic pipeline with multiple late-stage clinical programs built around three proprietary technologies: Latiglutenase, a targeted oral biotherapeutic for celiac disease designed to breakdown gluten into non-immunogenic peptides; the biologic Adrulipase, a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients in cystic fibrosis and chronic pancreatitis patients with exocrine pancreatic insufficiency, and Capeserod, a selective 5-HT4 receptor partial agonist which the Company is developing as a gastroparesis therapeutic.
AzurRx BioPharma to Present Interim Phase 2 Clinical Study Data for MS1819-SD, in Combination with Standard Pert for Cystic Fibrosis Patients with Severe Exocrine Pancreatic Insufficiency, At Biotech Showcase 2020 Conference (January 13) in San Francisco