Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDI048 · 1 trial · 1 indication
To determine the efficacy of EDI048 vs. placebo in healthy volunteers to reduce severity or resolve diarrhea.
| Arm | Type | Description |
|---|---|---|
| EDI048 | EXPERIMENTAL | Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get EDI048 administered orally. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive ABO809 as a single oral dose. If participant is symptomatic, then he/she would be randomized to get placebo administered orally. |
| Name | Type | Description |
|---|---|---|
| Cryptosporidium parvum oocysts (ABO809) | BIOLOGICAL | ABO809 oral suspension, single dose |
| EDI048 | DRUG | EDI048 administered orally |
| Placebo | OTHER | Placebo administered orally |
Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study. * Ability to communicate well with the Investigator, and to understand and comply with the requirements of the study. * Male and female participants must be between 18 to 50 years of age and in good ...
EDI048 is being developed for the treatment of cryptosporidiosis, an infectious disease caused by Cryptosporidium parasites. It is an investigational small molecule drug currently in Phase 2 clinical development. It is not yet approved for any indication.
EDI048 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker symbol NVS. Novartis is the sponsor of the clinical program evaluating the drug in cryptosporidiosis.
EDI048 is in Phase 2 clinical development. The program includes one active trial that is currently recruiting participants. No Phase 3 trials have been initiated, and the drug remains investigational.
EDI048 is being evaluated in a single Phase 2 trial, NCT07249463, titled a study testing the efficacy, safety, and tolerability of EDI048 in a Cryptosporidium infection model in healthy adults. The trial is recruiting, is placebo-controlled and double-blind, and plans to enroll 80 participants in the United States.
No. EDI048 is an investigational drug and has not been approved by the FDA. It is currently in Phase 2 clinical development for cryptosporidiosis, with one active trial recruiting participants. Approval, if it occurs, would require successful completion of later-stage trials and regulatory review.
The Phase 2 trial NCT07249463 enrolls healthy adult volunteers aged 18 years and older, with no restriction by sex. It uses a Cryptosporidium infection model in healthy adults rather than patients with naturally acquired infection, and it is randomized, double-blind, and placebo-controlled.