• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Anthera screens first patient in pivotal Sollpura study

Anthera screens first patient in pivotal Sollpura study

May 17, 2017
CenterWatch Staff

Anthera Pharmaceuticals has commenced screening in the RESULT phase III clinical study of Sollpura for exocrine pancreatic insufficiency due to cystic fibrosis. Based on feedback from the FDA, this non-inferiority study will compare the efficacy of Sollpura, a biologically manufactured pancreatic enzyme replacement therapy (PERT), to Pancreaze, a porcine-extracted PERT, as assessed by CFA after four weeks of treatment. Topline data are expected at the end of 2017 or early 2018, depending on the speed of patient enrollment.

“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. Steven R. Boas, M.D., FAAP, FACSM president and CEO, The Cystic Fibrosis Institute, Glenview, IL.

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 William Shanahan, chief medical officer, “and we appreciate the input from the US FDA and members of the CF Community in the design of RESULT. There is enthusiasm within patient and provider communities for a non-porcine derived product and we look forward to this important study.”

About RESULT

The phase III 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 four 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.

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Revamp-360x240.png

    Califf Calls for Major Evidence Generation Revamp, Experts’ Opinions Differ

  • AskTheExpertsGreen-360x240.png

    Ask the Experts: Managing Investigational Products

  • SurveywBlueBackground-360x240.png

    Survey Outlines Site Challenges, Successes on Diversity

  • PatientCentricity-360x240.png

    Site Spotlight: DM Clinical Shows Patient Centricity Doesn’t Have to Break the Bank

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing