NHS7108 for Pancreatic Insufficiency
(EPIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of a new treatment, NHS7108, for individuals with pancreatic insufficiency, a condition where the pancreas doesn't produce enough digestive enzymes. The study compares four different doses of NHS7108 with the standard treatment, Zenpep®, over several weeks. Participants will spend time in a controlled setting to monitor their diet and digestion. Ideal candidates for this trial are those who have had pancreatic insufficiency for some time and have been using enzyme replacement therapy to aid digestion. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in treatment.
Do I have to stop taking my current medications for the trial?
You will need to stop taking your usual pancrelipase or pancreatin treatment during the trial. However, you can continue taking standard-of-care medications like antibiotics and antacids if they have been stable for at least a month before the study and remain unchanged during the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that NHS7108, a new treatment using a lipase enzyme, is safe for humans. In earlier studies, researchers tested NHS7108 in various amounts and found no major safety problems. The treatment did not cause harm, and participants generally tolerated it well. Notably, NHS7108 does not enter the bloodstream, reducing the risk of side effects.
In another study with 48 participants, researchers found no safety issues during both single and repeated doses. The evidence so far suggests that NHS7108 is safe to use, making it a promising option for treating conditions like exocrine pancreatic insufficiency (EPI), where the pancreas doesn't produce enough enzymes to digest food properly. However, ongoing research will continue to assess its safety and effectiveness.12345Why are researchers excited about this trial's treatments?
Researchers are excited about NHS7108 for pancreatic insufficiency because it offers a potentially new approach to managing this condition. Unlike standard treatments like pancreatic enzyme replacement therapies (PERT) such as Creon or Zenpep, which are derived from porcine sources, NHS7108 is a synthetic enzyme replacement. This novel formulation could mean more precise dosing and potentially fewer side effects related to animal-derived products. Additionally, NHS7108 is being tested in various doses, which might help tailor treatments more effectively to individual patient needs.
What evidence suggests that this trial's treatments could be effective for pancreatic insufficiency?
Research has shown that NHS7108 could help treat exocrine pancreatic insufficiency (EPI). In earlier studies, NHS7108, a new type of enzyme, improved fat absorption in patients, addressing a major issue in EPI. Designed to withstand stomach acid, this enzyme functions effectively during digestion. Previous research found it safe and confirmed it did not enter the bloodstream, suggesting it might be a safe option. These findings indicate that NHS7108 could serve as a good alternative to current enzyme treatments.12467
Who Is on the Research Team?
Monique Bunyan
Principal Investigator
Aimmune Nestlé Health Science US R&D, LLC (Role: Associate Clinical Project Manager)
Are You a Good Fit for This Trial?
This trial is for adults aged 18-85 with chronic exocrine pancreatic insufficiency (EPI) who need enzyme replacement therapy. Participants must have trouble absorbing fat, a BMI between 17 and 35, be able to consent, and meet contraceptive requirements. People with certain other diseases or recent medication changes can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive NHS7108 or Zenpep® for 14 days with controlled diet and stool collection
Treatment Period 2
Participants crossover to receive the alternate treatment (NHS7108 or Zenpep®) for another 14 days
End of Treatment
End of treatment/early discontinuation visit within approximately 7 days of the last study intervention dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NHS7108
Trial Overview
The study compares four different doses of a new oral enzyme (NHS7108) to the standard treatment (Zenpep®), both taken as capsules with meals and snacks over two separate 14-day periods. Each participant tries both treatments in random order to see which works better and is safer.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
10 mg NHS7108 \[approximately 25,000 LU\]/main meal and snack; 25,000 LU Zenpep/main meal and snack.
40 mg NHS7108 \[approximately 100,000 LU\]/main meal and 20 mg NHS7108 \[approximately 50,000 LU\]/snack; 100,000 LU Zenpep/main meal and 50,000 LU Zenpep/snack.
20 mg NHS7108 \[approximately 50,000 LU\]/main meal and 10 mg NHS7108 \[approximately 25,000 LU\]/snack; 50,000 LU Zenpep/main meal and 25,000 LU Zenpep/snack.
60 mg NHS7108 \[approximately 150,000 LU\]/main meal and 30 mg NHS7108 \[approximately 75,000 LU\]/snack; 150,000 LU Zenpep/main meal and 75,000 LU Zenpep/snack.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aimmune Nestlé Health Science US R&D, LLC
Lead Sponsor
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland
Citations
A Study to Evaluate Safety and Explore Efficacy of New ...
The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants ...
2.
journals.lww.com
journals.lww.com/ajg/fulltext/2024/10001/s75_a_study_of_safety,_pharmacokinetics,_and.76.aspxS75 A Study of Safety, Pharmacokinetics, and Proof- ...
NHS7108, a novel oral recombinant lipase, was well tolerated at all tested doses and without systemic absorption. Breath testing confirmed improved fat ...
Codexis and Nestlé Health Science Announce Interim Results ...
Codexis and Nestlé Health Science Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency.
ACG 2024 Annual Meeting
NHS7108 is an oral, pH-stable, gastric-acid-resistant, highly potent, recombinant lipase derived from Bacillus thermoamylovans with the potential to optimize ...
Drug Development Pipeline | CFF Clinical Trials Tool
... pancreatic insufficiency. It is a man-made version of a lipase enzyme taken ... NHS7108 could eventually provide an alternative to existing pancreatic enzyme ...
Drug Development Pipeline | CFF Clinical Trials Tool
... pancreatic insufficiency. It is a man-made version of a lipase enzyme taken ... NHS7108 could eventually provide an alternative to existing pancreatic enzyme ...
Oral CDX-7108 in Healthy Adults and EPI Subjects
This is the first-in-human (FIH) study of CDX-7108, which aims to assess the safety, tolerability, pharmacokinetics (PK) of escalating single and multiple oral ...
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