Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alicaforsen · 2 trials · 2 indications
The group of patients with an improvement in their endoscopic score between screening and week 10 as shown by an reduced modified MAYO score. Remission is defined as absence of friability and ulceration, represented by a score of ≤1.
Group of patients with a lowering of stool frequency from baseline to week 10, where the subject's stool frequency is represented by a MAYO subscore of ≤1 at week 10.
Area under the curve recovery of alicaforsen in plasma
| Arm | Type | Description |
|---|---|---|
| Alicaforsen | EXPERIMENTAL | Alicaforsen enema, 240mg once daily for 6 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo enema, once daily for 6 weeks |
| Alicaforsen tablets | EXPERIMENTAL | Regimen A - Alicaforsen tablets with food |
| Name | Type | Description |
|---|---|---|
| Alicaforsen | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. Written informed consent; 2. Male or female subjects, 18 years of age who have undergone an IPAA for UC 3. History of pouchitis 4. Overall PDAI score \> 7 5. Must have Chronic Antibiotic Refractory Pouchitis Exclusion Criteria: 1. Lack of effective contraception 2. Women wh...
Alicaforsen is an investigational small molecule being developed for gastrointestinal conditions, specifically inflammatory bowel disease (IBD) and pouchitis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Alicaforsen is being developed by Atlantic International Corp. (ticker: ATLN). The company is conducting clinical trials to evaluate the drug's safety and efficacy in gastrointestinal indications.
Alicaforsen is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. Clinical trials are ongoing to assess its safety and pharmacokinetics.
Alicaforsen has been studied in two completed trials: NCT02525523, a Phase 3 efficacy study in pouchitis patients who failed antibiotics, and NCT03473626, a Phase 1 food effect study in healthy volunteers with IBD. The Phase 3 trial enrolled 138 participants across multiple countries.
Alicaforsen is a distinct investigational small molecule being developed for IBD and pouchitis. It is not known to be the same as any other approved drug, and its mechanism of action has not been publicly disclosed in the available data.