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Also known as PALI-2108 active drug
PALI-2108 · 3 trials · 5 indications
The Modified Mayo Score (MMS) is a composite score of ulcerative colitis (UC) disease activity on a scale of increasing severity from 0-9, calculated by summing three subscores: Endoscopic subscore (ES), scored on a scale of increasing severity from 0 (normal or inactive disease) to 3 (severe disease, such as spontaneous bleeding or ulceration); Stool frequency subscore (SFS), scored on a scale of increasing frequency from 0 (normal number of stools) to 3 (≥5 stools more than normal per day for the participant); and rectal bleeding subscore (RBS), scored on a scale of increasing severity from 0 (no blood seen) to 3 (blood alone passed). Clinical Remission is defined as an ES of 0 or 1, RBS of 0, and SFS of 0 or 1 and not greater than the baseline SFS.
Adverse events in FSCD patients receiving PALI-2108
Incidence of clinically significant laboratory abnormalities
Incidence of Treatment Emergent Adverse Events (TEAE) or abnormal clinical laboratory measure, electrocardiogram (ECG), or vital sign.
| Arm | Type | Description |
|---|---|---|
| PALI-2108 Dose 1 | EXPERIMENTAL | 15mg QD |
| PALI-2108 Dose 2 | EXPERIMENTAL | 30mg QD |
| Placebo | PLACEBO_COMPARATOR | QD |
| FSCD Arm | EXPERIMENTAL | PALI-2108 All participants receive once-daily oral PALI-2108 for 14 days in the fed state. Two sentinel subjects receive a titrated regimen from 5 mg to 20 mg. After 7 days of sentinel dosing, the Safety Review Committee (SRC) reviews safety data and assigns the subsequent two patients to a target dose of 25 mg, with a predefined titration schedule. If the 25 mg dose is judged to be safe, all remaining subjects receive a target daily dose of 30 mg, also with a predefined titration scheme. Dose reductions may occur if safety profile is not judged adequate by SRC. Dosing is site-administered except on protocol-specified days when self-administration at home is permitted. |
| PALI-2108 | EXPERIMENTAL | Part A - Single Ascending oral doses of PALI-2108 in healthy adult subjects. Part B - Single oral dose crossover of PALI-2108 in healthy adult subjects. Part C - Multiple Ascending oral Doses of PALI-2108 in healthy adult subjects. Part D - (open-label) Multiple oral Doses of PALI-2108 in Ulcerative Colitis patients. |
| PALI-2108 Placebo | PLACEBO_COMPARATOR | Part A - Single Ascending oral Dose of matching placebo in healthy adult subjects. Part B - Single Ascending oral Dose of matching placebo crossover of PALI-2108 in healthy adult subjects. Part C - Multiple Ascending oral Doses of matching placebo in healthy adult subjects. Part D - (open-label) Multiple Ascending oral Doses of matching placebo in Ulcerative Colitis patients. |
| Name | Type | Description |
|---|---|---|
| PALI-2108 | DRUG | Oral Dose |
| Placebo | DRUG | Oral Dose |
| PALI-2108 Placebo | DRUG | Oral dose |
Key Inclusion Criteria: * Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence. * If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to ob...
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PALI-2108 is an investigational oral small molecule being developed for fibrostenotic Crohn's disease and ulcerative colitis, two inflammatory bowel diseases. It is also being studied in healthy volunteers. It is not approved for any indication and remains in clinical development.
PALI-2108 targets phosphodiesterase 4, or PDE4, an enzyme. By acting on PDE4, the drug is designed to modulate inflammatory signaling. PDE4 is the molecular target of PALI-2108, and the compound is a small molecule.
PALI-2108 is being developed by Palisade Bio, Inc., which trades on the Nasdaq under the ticker PALI. The company is the sponsor of the clinical program evaluating the drug in ulcerative colitis and fibrostenotic Crohn's disease.
PALI-2108 is in Phase 1 development, with a Phase 2 trial also under way. It is investigational and has not been approved by the FDA for any indication. The program includes a completed Phase 1 study, an active Phase 1 study, and a recruiting Phase 2 trial.
PALI-2108 has been studied in three registered trials. NCT06663605 was a completed Phase 1 study in healthy volunteers and ulcerative colitis patients. NCT07428096 is an active Phase 1 study in healthy volunteers, ulcerative colitis, and fibrostenosing Crohn's disease patients. NCT07845487 is a recruiting Phase 2 trial in moderately to severely active ulcerative colitis.
No. PALI-2108 is investigational and has not been approved by the FDA. It is still in clinical development, with Phase 1 studies completed or ongoing and a Phase 2 trial in ulcerative colitis currently recruiting participants.