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PN-943 · 1 trial · 2 indications
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS)
| Arm | Type | Description |
|---|---|---|
| PN-943 450 mg BID | EXPERIMENTAL | Oral administration of PN-943 450 mg BID |
| PN-943 150 mg BID | EXPERIMENTAL | Oral administration of PN-943 150 mg BID |
| Placebo BID | PLACEBO_COMPARATOR | Oral administration of matching placebo |
| Name | Type | Description |
|---|---|---|
| PN-943 | DRUG | Administered by the oral route BID for the duration of the study. |
| Placebo | DRUG | Administered by the oral route BID for 12 weeks. |
Key Inclusion Criteria: 1. Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years. 2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. 3. Diagnosis of UC supported by appropriate documen...
PN-943 is an investigational oral small molecule developed by Protagonist Therapeutics, Inc. for chronic moderate ulcerative colitis. It is an integrin-targeted therapy that has completed a Phase 2 clinical trial. PN-943 is not approved and remains in clinical development.
PN-943 is being developed for the treatment of chronic moderate ulcerative colitis, a form of inflammatory bowel disease affecting the colon. It was studied in adults with moderate to severe active ulcerative colitis. The drug is investigational and has not been approved for any indication.
PN-943 targets alpha-4-beta-7 integrin, a member of the integrin target class. Alpha-4-beta-7 integrin mediates lymphocyte trafficking to the gastrointestinal tract, and blocking it is intended to reduce gut inflammation in ulcerative colitis.
PN-943 is developed by Protagonist Therapeutics, Inc., which trades on the Nasdaq under the ticker PTGX. The company is a clinical-stage biopharmaceutical company focused on peptide and small molecule therapeutics.
PN-943 is in Phase 2 development. Its single Phase 2 trial, NCT04504383, has been completed. The study was randomized, double-blind, and placebo-controlled, enrolling 169 adults with moderate to severe active ulcerative colitis across the United States, Europe, and South Korea.
PN-943 has been studied in one Phase 2 trial, NCT04504383, titled PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis. The trial enrolled 169 participants, was randomized, double-blind, and placebo-controlled, and has completed. It included sites in the United States, Canada, Europe, and South Korea.