Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Double-Blind CBP-307 · 1 trial · 1 indication
Change in adapted Mayo score from baseline at week 12 compared between CBP-307 0.2 mg and placebo in the Full Analysis Set by Multiple Imputation. Adapted Mayo scores were calculated based on data in stool frequency, rectal bleeding, and endoscopic findings. The Mayo scores range from 0 to 9 and consist of 3 subscores, each ranging from 0 to 3. The higher the score is, the more severe the disease is.
| Arm | Type | Description |
|---|---|---|
| Double-Blind 0.2mg CBP-307 | EXPERIMENTAL | 0.2 mg CBP-307 capsules oral administration. |
| Double-Blind Placebo | PLACEBO_COMPARATOR | Placebo capsules oral administration. |
| Open-Label CBP-307 | EXPERIMENTAL | 0.2 mg CBP-307 capsules oral administration. |
| Double-Blind 0.1mg CBP-307 | EXPERIMENTAL | 0.1 mg CBP-307 capsules oral administration. |
| Name | Type | Description |
|---|---|---|
| Double-Blind 0.2mg CBP-307 | DRUG | 0.2 mg capsule oral administration |
| Double-Blind Placebo | DRUG | Placebo capsule oral administration |
| Open-label CBP-307 | DRUG | 0.2 mg capsule oral administration |
| Double-Blind 0.1mg CBP-307 | DRUG | 0.1 mg capsule oral administration |
Main inclusion and exclusion criteria for the study Stage 1: Subjects were eligible to be included in the study only if all the following criteria applied: * Male or female subjects aged 18 to 75 years (inclusive) with a diagnosis of UC established at least 3 months prior to screening by clinical ...
CBP-307 is an investigational small molecule being developed for autoimmune diseases, including moderate to severe ulcerative colitis. It has been studied in healthy adult subjects as well. The drug is in clinical development and is not approved by the FDA.
CBP-307 is being developed by Connect Biopharma Holdings Limited, a biopharmaceutical company traded on the NASDAQ under the ticker symbol CNTB. The company has conducted clinical trials of CBP-307 in multiple countries.
CBP-307 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial evaluated the drug in patients with moderate to severe ulcerative colitis. CBP-307 remains investigational and is not FDA approved.
CBP-307 has been studied in several completed trials, including NCT02280434 (Phase 1 safety and tolerability in autoimmune diseases), NCT04700449 (Phase 2 efficacy and safety in ulcerative colitis), NCT04818229 (Phase 1 QT interval study), and NCT05040113 (Phase 1 mass balance study).
CBP-307 is a distinct investigational small molecule developed by Connect Biopharma. No alternative names for CBP-307 have been reported in the clinical trial data.