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AGMB-129 · 4 trials · 2 indications
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of adverse events at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal laboratory parameters at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of abnormal ECG parameters at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of vital signs at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of physical exams at every visit
To evaluate the safety and tolerability of AGMB-129 between AGMB-129 participants and placebo participants in terms of echocardiography at week 12
To evaluate the safety and tolerability of AGMB-129 in terms of adverse events (AE) at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of physical examination at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of vital signs
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal electrocardiograms (ECGs) at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal 2-dimensional (2-D) echocardiography at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal clinical laboratory parameters at every visit
| Arm | Type | Description |
|---|---|---|
| AGMB-129 High | EXPERIMENTAL | AGMB-129 high dose |
| AGMB-129 Low | EXPERIMENTAL | AGMB-129 low dose |
| Placebo | EXPERIMENTAL | Matching placebo |
| AGMB-129 | EXPERIMENTAL | participants will receive a single dose of AGMB-129 (reference cohort) for 7 consecutive days or multiple doses of AGMB-129 (cohort 1, 2, 3) for 7 consecutive days |
| 1 | EXPERIMENTAL | ABC with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 2 | EXPERIMENTAL | CAB with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 3 | EXPERIMENTAL | BCA with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 4 | EXPERIMENTAL | CBA with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 5 | EXPERIMENTAL | BAC with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| 6 | EXPERIMENTAL | ACB with A=oral capsule under fed conditions B=oral tablet under fasted conditions C=oral tablet under fed conditions |
| Name | Type | Description |
|---|---|---|
| AGMB-129 | DRUG | Oral capsule |
| Placebo | DRUG | Matching oral capsule |
| MDZ | DRUG | Pre-filled oral syringes |
Inclusion Criteria (Part A): 1. Diagnosis of ileal or ileocolonic CD based on supporting guideline criteria (eg, clinical, endoscopic, and histologic evidence) established at least 3 months prior to screening. 2. Presence of at least 1 stricture in the terminal ileum within reach of an endoscope (p...
AGMB-129 is an investigational small molecule being developed for fibrostenotic Crohn's disease, a gastrointestinal condition. It has also been studied in healthy volunteers for pharmacokinetic and drug interaction purposes. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
AGMB-129 is being developed by AgomAb Therapeutics NV, a biopharmaceutical company. The company's ticker symbol is AGMB. AgomAb is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for fibrostenotic Crohn's disease.
AGMB-129 is in Phase 2 clinical development. It has completed two Phase 1 trials and one Phase 2 trial, all of which are finished. The drug remains investigational and has not received FDA approval for any indication.
AGMB-129 has completed several clinical trials, including NCT05843578 (STENOVA), a Phase 2 study in patients with fibrostenotic Crohn's disease, and NCT05937386, a drug-drug interaction study with midazolam in healthy participants. Other completed trials include NCT06397508 and NCT07118878, both in healthy volunteers.
STENOVA is the name of a clinical trial, not an alternative name for AGMB-129. The trial NCT05843578, titled STENOVA, evaluates AGMB-129 in patients with fibrostenotic Crohn's disease. AGMB-129 is the investigational drug being tested in that study.
The specific molecular target of AGMB-129 has not been disclosed in available information. It is classified as a small molecule therapeutic. Clinical trials are evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with fibrostenotic Crohn's disease.