Phase 2 Study to Assess the Safety and Efficacy of Two Dose Levels of ANG003
Research type
Research Study
Full title
A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
IRAS ID
1013658
Contact name
Danielle Gallotto
Contact email
Sponsor organisation
Anagram Therapeutics, Inc.
Eudract number
2025-524569-25
Clinicaltrials.gov Identifier
Research summary
Cystic Fibrosis (CF) is an inherited disease that is caused by a mutation (that is, a defect in genes) that causes the body to produce mucus that is thicker than normal. In persons with CF, thicker mucus has trouble moving through the airways which contributes to repeated flare-ups or worsening of lung disease symptoms. This mutation also thickens the mucous in pancreatic ducts ultimately causing injury to pancreas, and leads to exocrine pancreatic insufficiency (EPI), which is the inability to properly release pancreatic enzymes that help digest and absorb food so that body can use it.
While there are treatment options available for EPI, there remains significant unmet medical needs in terms of ensuring patient safety, providing consistent drug supply, managing disease progression, and compliance issues. Exocrine pancreatic insufficiency remains a major condition despite the introduction of the new revolutionary medicines, called cystic fibrosis transmembrane conductance regulator (CFTR) modulators. Continued research and innovation are necessary to provide alternative solutions for CF patients suffering from EPI. ANG003 may provide a non-porcine derived (that is, not from a pig) product as an alternative for patients with EPI to meet the unmet needs of this population. This unmet need provides significant challenges in certain patients, including those with religious or cultural beliefs that have restrictions concerning consuming pork and those with allergies to pork.
In this trial, ANG003, a pancreatic enzyme replacement therapy (PERT), is being investigated as a potential treatment for EPI. The primary objective of this trial is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved porcine PERT, with respect to absorption of fats. The secondary objectives are to evaluate how well ANG003 and Creon work on absorption of fats and proteins and gastrointestinal symptoms.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0115
Date of REC Opinion
9 Jul 2026
REC opinion
Further Information Favourable Opinion