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Also known as eRapa (encapsulated rapamycin)
eRapa · 1 trial · 1 indication
* Death from any cause * Cancer/high-grade dysplasia * Major FAP-related surgery (e.g., colectomy, proctectomy, total proctocolectomy with ileal pouch anal anastomosis \[IPAA\], pouch resection, ileostomy, duodenectomy, or surgical ampullectomy) * Advancement of Spigelman stage (not related solely to increase in polyp number) * Meets criteria for surgery (consistent with United States \[US\] and European Union \[EU\] practice guidelines) (Yang, Gurudu et al. 2020, Zaffaroni, Mannucci et al.2024) * Retained rectum/sigmoid or pouch (≥10 polyps ≥3 mm in size at baseline) * Duodenum (Stage 3/4 and at least 1 polyp ≥10 mm removed in last 18 months)
| Arm | Type | Description |
|---|---|---|
| eRapa | EXPERIMENTAL | 0.5 mg eRapa once a day (QD) every other week |
| Placebo | PLACEBO_COMPARATOR | Placebo once a day (QD) every other week |
| Name | Type | Description |
|---|---|---|
| eRapa (encapsulated rapamycin) | DRUG | 0.5 mg capsules for oral use; white opaque capsule filled with off-white powder; Trial intervention will be provided in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal. |
| Placebo | DRUG | Capsules in 28-count round high-density polyethylene bottles with a polypropylene child-resistant screw cap and foil induction seal. |
Inclusion Criteria: 1. Participant must be ≥18 years of age inclusive. 2. Participant must have documented FAP, confirmed by adenomatous polyposis coli genotype mutation testing. 3. Participant must have at least 1 of the following high-risk features: \>100 polyps but ≤500 polyps in the colon, or ≥...
eRapa is an investigational small molecule being developed for Familial Adenomatous Polyposis (FAP), a gastrointestinal condition. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug is being studied in a randomized, double-blind, placebo-controlled trial to evaluate its effects in patients with FAP.
eRapa is an encapsulated form of rapamycin, which is a small molecule that inhibits the mTOR pathway. By targeting this pathway, eRapa is being studied for its potential to affect disease progression in Familial Adenomatous Polyposis (FAP). The drug is currently in Phase 3 clinical trials for this indication.
eRapa is being developed by Biodexa Pharmaceuticals plc, a biopharmaceutical company listed on the stock exchange under the ticker BDRX. The company is conducting a Phase 3 clinical trial of eRapa in patients with Familial Adenomatous Polyposis (FAP).
eRapa is currently in Phase 3 clinical development for Familial Adenomatous Polyposis (FAP). It is an investigational drug and has not been approved by the FDA. The Phase 3 trial is actively recruiting participants and is designed as a randomized, double-blind, placebo-controlled study.
eRapa is being studied in a Phase 3 clinical trial with the identifier NCT06950385, titled 'Phase 3 Trial of eRapa in Patients With Familial Adenomatous Polyposis.' This trial is recruiting 168 participants across the United States, Denmark, Germany, Netherlands, Puerto Rico, and Spain. The study is randomized, double-blind, and placebo-controlled.
eRapa is an encapsulated form of rapamycin, meaning it contains rapamycin as its active ingredient but is formulated in a special encapsulation. This formulation is being developed by Biodexa Pharmaceuticals for Familial Adenomatous Polyposis (FAP). The drug is currently in Phase 3 clinical trials and has received FDA Fast Track and Orphan Drug designations.