"As a key investigator in the SOLUTION study and now participating in the RESULT study, I am excited to be part of this important study for Cystic Fibrosis patients with exocrine pancreatic insufficiency. Sollpura has the potential to address an unmet need for PERTs with a reduction in pill burden, as well as the benefit of a product that is not extracted from pigs," shared Dr.
The RESULT clinical study builds upon data from the previous Sollpura trial (SOLUTION) and allows for more frequent and higher dose adjustments based upon clinical signs and symptoms. As with current practice with porcine enzymes, the RESULT study allows patients to increase their daily dose to an individualized dose that achieves maximum therapeutic benefit, while maintaining a potential reduction in daily pill burden as compared to porcine PERTs.
"We are very pleased to achieve this important milestone for Sollpura," shared
The Phase 3 RESULT study is designed to evaluate the non-inferiority of Sollpura at individualized doses compared to approved, porcine-derived, enteric-coated PERT when administered to patients with exocrine pancreatic insufficiency due to cystic fibrosis. The study will enroll patients (N≈150) with exocrine pancreatic insufficiency due to cystic fibrosis who are well controlled on stable porcine PERT at screening, as demonstrated by a minimum CFA. The primary efficacy variable will evaluate the change from baseline in CFA following 4 weeks of treatment with either Sollpura or Pancreaze. Patients randomized to Sollpura will then be followed for an additional 20-Week extension period (total of 24 weeks on study) for additional assessments of weight, height, BMI, and safety.
About Sollpura® (liprotamase)
Sollpura is a novel, non-porcine PERT containing a proprietary, biotechnology-derived formulation of cross-linked crystalline lipase, crystalline protease, and amorphous amylase with broad substrate specificity, that has been designed for purity (no potential for porcine viral contamination), formulation of enzymes in a precise and fixed ratio, stability in acid pH without enteric coating, and activity in the proximal small intestine.
Sollpura represents potentially the first soluble, stable and non-pig derived enzyme product to offer a solution to people with EPI, including young children and adults, who are either unable to swallow multiple pills or require gastric tubes in order to maintain appropriate nutritional health.
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