Approval Probability
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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 RNA therapy being developed for inflammatory bowel disease (IBD) and pouchitis. It is designed to treat pouchitis patients who have not responded to at least one course of antibiotics, as studied in a completed Phase 3 trial. It is not approved for any indication.
Alicaforsen targets ICAM1, also known as intercellular adhesion molecule 1. It is an antisense inhibitor that reduces the production of ICAM1, a protein involved in inflammatory cell adhesion and signaling. This mechanism is intended to dampen inflammation in gastrointestinal conditions such as IBD and pouchitis.
Alicaforsen is being developed by Atlantic International Corp., which trades under the ticker ATLN. The company is advancing the drug as an RNA therapy for gastrointestinal indications, including IBD and pouchitis.
Alicaforsen is in Phase 1 development. A Phase 1 food effect study in healthy volunteers has been completed, and a Phase 3 trial in pouchitis patients has also been completed. The drug remains investigational and has not been approved by the FDA or any regulatory agency.
Alicaforsen has been studied in two completed trials: NCT03473626, a Phase 1 food effect study in 15 healthy male volunteers in the United Kingdom, and NCT02525523, a Phase 3 trial in 138 pouchitis patients across multiple countries. No active trials are currently listed.