EDI048 for Cryptosporidiosis
(CRYPTONITE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called EDI048 for cryptosporidiosis, a stomach illness caused by a parasite. The trial aims to determine if EDI048 can reduce symptoms in adults, potentially benefiting children with the same condition later. Participants will first receive a substance that induces symptoms similar to cryptosporidiosis and then receive either EDI048 or a placebo. Healthy adults who have not had cryptosporidiosis and understand how to prevent its spread would be a good fit for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot participate if you have used investigational drugs recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that EDI048 is likely to be safe for humans?
Research has shown that EDI048 is designed to remain in the gut and not spread extensively throughout the body, reducing the likelihood of side effects in other areas. Studies have found that EDI048 breaks down predictably, enhancing its safety profile. To date, no serious side effects have been reported in people, making EDI048 a promising option for treating cryptosporidiosis, especially in children.12345
Why do researchers think this study treatment might be promising for cryptosporidiosis?
Researchers are excited about EDI048 for cryptosporidiosis because it offers a fresh approach to tackling this stubborn infection. Unlike standard treatments that primarily focus on alleviating symptoms, EDI048 targets the parasite directly, potentially stopping it more effectively. Additionally, as an oral medication, it could provide a convenient and easy-to-administer alternative to existing therapies, which often require longer treatment durations or are less targeted. This new mechanism of action and delivery method could mean faster relief and recovery for patients.
What evidence suggests that EDI048 might be an effective treatment for cryptosporidiosis?
Research has shown that EDI048, which participants in this trial may receive, may help treat cryptosporidiosis. In studies with young calves, EDI048 quickly stopped diarrhea and greatly reduced the number of parasites in their stool. This indicates that EDI048 works effectively in the stomach and intestines to lower the number of parasites causing the illness. The drug primarily acts in the digestive system and is quickly broken down by the liver, limiting its effects on other parts of the body. These results offer hope that EDI048 could effectively treat children with cryptosporidiosis.13678
Are You a Good Fit for This Trial?
Healthy adults aged 18-50 with a BMI of 18-32 kg/m2, who understand cryptosporidiosis and can prevent its spread. Participants must be in good health as confirmed by medical exams and tests. They cannot have taken ABO809 or EDI048 before.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Infection Induction
Participants are administered Cryptosporidium parvum oocysts (ABO809) to develop symptoms consistent with cryptosporidiosis
Treatment
Participants receive EDI048 or placebo after developing symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- EDI048
Trial Overview
The trial is testing the effectiveness of EDI048 against symptoms of cryptosporidiosis, using healthy adults infected with Cryptosporidium parvum (ABO809). The goal is to see if it helps before trying it in children with the disease.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get EDI048 administered orally.
Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get placebo administered orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
Study Testing the Efficacy, Safety, and Tolerability of ...
This study aims to investigate the efficacy of a new chemical entity, EDI048, in a controlled human infection model of cryptosporidiosis induced ...
Cryptosporidium PI(4)K inhibitor EDI048 is a gut-restricted ...
In neonatal calves, a clinical model of cryptosporidiosis, EDI048 treatment resulted in rapid resolution of diarrhoea and significant reduction in faecal oocyst ...
NVP-EDI048: A Gut-Restricted Soft Drug To Treat Pediatric ...
It is stable in the GI tract, where it reduces parasite burden, resolves diarrhea, and undergoes rapid hepatic metabolism to minimize systemic ...
EDI-048 - Drug Targets, Indications, Patents
In neonatal calves, a clinical model of cryptosporidiosis, EDI048 treatment resulted in rapid resolution of diarrhoea and significant reduction ...
5.
parasite-journal.org
parasite-journal.org/articles/parasite/full_html/2025/01/parasite240139/parasite240139.htmlMolecular pathogenesis of Cryptosporidium and ...
The results indicated that both red and white pomegranate skin extracts were effective in reducing fecal oocyst excretion in infected mice ...
Cryptosporidium PI(4)K inhibitor EDI048 is a gut-restricted ...
Safety and pharmacological studies demonstrated predictable metabolism and low systemic exposure of EDI048, providing a substantial safety ...
First in human study to assess the safety, tolerability and ...
The sponsor is developing the test medicine, EDI048 for the potential treatment of cryptosporidiosis. Cryptosporidiosis is an infection caused by parasites that ...
8VOF: GI targeted CpPI4K inhibitor
Safety and pharmacological studies demonstrated predictable metabolism and low systemic exposure of EDI048, providing a substantial safety ...
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