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Also known as Encapsulated Rapamycin (eRapa)
Encapsulated Rapamycin · 1 trial · 1 indication
Safety and tolerability of eRapa as determined by graded toxicity assessed throughout the trial per CTCAE v5.0.
The Recommended Phase 2 Dose (RP2D) will be determined by examining and analyzing safety/ adverse events as reflected by Outcome 1, dose delays, dose reductions, withdrawal of treatment secondary to low-grade toxicities, and serum pharmacokinetic monitoring.
Percentage change from baseline in colorectal polyp burden as measure by endoscopy at 6 months.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 will receive 0.5mg of eRapa every other day. |
| Cohort 2 | EXPERIMENTAL | Cohort 2 will receive 0.5mg of eRapa daily with 7 days on therapy, followed by 7 days off therapy. |
| Cohort 3 | EXPERIMENTAL | Cohort 3 will receive 0.5 mg of eRapa daily. |
| Food Effect | EXPERIMENTAL | Upon identification of the RP2D, after a 2 week washout (14 days), subjects will be randomized into a fed and fasted (2 weeks - 14 days) two period cross over, with an intervening 2 week washout (14 days) for a total of 2 months (8 weeks). |
| Name | Type | Description |
|---|---|---|
| Encapsulated Rapamycin (eRapa) | DRUG | eRapa is encapsulated rapamycin. The rapamycin is encapsulated in order to deliver the rapamycin at a consistent and lower dosage. eRapa is a capsule, and is administered orally. |
Inclusion Criteria: 1. Sign and date an informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, age at least 18 years at the time of consent. 4. Phenotypic familial adenomatous polyposis (FAP) with disease i...
Encapsulated Rapamycin (eRapa) is an investigational small molecule being studied for Familial Adenomatous Polyposis (FAP), a gastrointestinal condition. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
Encapsulated Rapamycin (eRapa) is a small molecule that works by inhibiting the mTOR pathway, which is involved in cell growth and proliferation. By targeting this pathway, it aims to prevent the progression of polyps in patients with Familial Adenomatous Polyposis.
Encapsulated Rapamycin (eRapa) is being developed by Biodexa Pharmaceuticals plc, a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Familial Adenomatous Polyposis.
Encapsulated Rapamycin (eRapa) is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants.
Encapsulated Rapamycin (eRapa) is being evaluated in a Phase 2 clinical trial with the identifier NCT04230499. The trial is titled 'Trial of ERapa to Prevent Progression in Familial Adenomatous Polyposis Patients Under Active Surveillance' and is enrolling 30 participants in the United States.
Yes, Encapsulated Rapamycin is also known as eRapa. The drug is being studied under the name eRapa in clinical trials for Familial Adenomatous Polyposis, and both names refer to the same investigational small molecule.