Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Double-Blind CBP-307
CBP-307 · 3 trials · 2 indications
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.
Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.
Safety measurements will include vital signs, hematology, blood chemistry, blood pressure and other readouts.
| 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. |
| Investigational Group 1 | EXPERIMENTAL | Therapeutic and supratherapeutic multiple oral doses of CBP-307. |
| Investigational Group 2A | PLACEBO_COMPARATOR | Moxifloxacin (positive control for method validation) and Placebo oral administration. |
| Investigational Group 2B | PLACEBO_COMPARATOR | Moxifloxacin (positive control for method validation) and Placebo oral administration. |
| CBP-307 | ACTIVE_COMPARATOR | Participants will receive a single dose or once daily dose of CBP-307 for 28 days. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose or once daily dose of matching placebo for 28 days. |
| 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 |
| CBP-307 | DRUG | CBP-307 capsules oral administration. |
| Placebo-matched CBP-307 | DRUG | Placebo-matched CBP-307 capsules oral administration. |
| Moxifloxacin (Avelox) | DRUG | Moxifloxacin tablets oral administration。 |
| Placebo-matched Moxifloxacin | DRUG | Placebo-matched Moxifloxacin tablets oral administration. |
| Placebo | DRUG | - |
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 drug being developed by Connect Biopharma Holdings Limited for autoimmune diseases, including moderate to severe ulcerative colitis. It is designed to modulate the S1P1 receptor, which is involved in T cell trafficking. CBP-307 has been studied in clinical trials and is not yet approved for any indication.
CBP-307 is being evaluated for the treatment of moderate to severe ulcerative colitis. A Phase 2 clinical trial (NCT04700449) assessed its efficacy and safety in subjects with this condition. The trial has been completed, but CBP-307 remains investigational and is not approved for ulcerative colitis or any other indication.
CBP-307 targets the S1P1 receptor, a G protein-coupled receptor that regulates lymphocyte egress from lymph nodes. By modulating S1P1, CBP-307 is intended to reduce T cell trafficking to sites of inflammation. This mechanism is being explored for autoimmune diseases such as ulcerative colitis.
CBP-307 is being developed by Connect Biopharma Holdings Limited, a clinical-stage biopharmaceutical company. The company's ticker symbol is CNTB. Connect Biopharma is focused on developing therapies for autoimmune diseases.
CBP-307 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials (NCT04818229 and NCT02280434) evaluated safety and tolerability, while the Phase 2 trial (NCT04700449) assessed efficacy and safety in moderate to severe ulcerative colitis. CBP-307 is not FDA approved and remains investigational.
CBP-307 has been studied in three completed clinical trials: NCT04818229, a Phase 1 QT interval study in healthy subjects; NCT04700449, a Phase 2 efficacy and safety study in moderate to severe ulcerative colitis; and NCT02280434, a Phase 1 safety and tolerability study in healthy male subjects. All trials are completed.
Yes, CBP-307 is also referred to as Double-Blind CBP-307 or Double-Blind 0.2mg CBP-307. These alternative names reflect the double-blind, placebo-controlled design used in its clinical trials. CBP-307 is the primary name for this investigational drug developed by Connect Biopharma.