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Also known as Ontunisertib
AGMB-129 · 4 trials · 1 indication
To evaluate the efficacy and dose-response relationship of multiple doses of ontunisertib
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
Part 1: To determine the absolute oral bioavailability of ontunisertib
Part 2: To determine the mass balance recovery after a single oral dose of \[14C\]ontunisertib
Part 2: To characterize the metabolite profile in plasma and excreta (urine and/or feces) after a single oral dose of \[14C\]ontunisertib
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 |
|---|---|---|
| Ontunisertib High | EXPERIMENTAL | Ontunisertib high dose |
| Ontunisertib Medium | EXPERIMENTAL | Ontunisertib medium dose |
| Ontunisertib Low | EXPERIMENTAL | Ontunisertib low dose |
| Placebo | EXPERIMENTAL | Matching placebo |
| AGMB-129 High | EXPERIMENTAL | AGMB-129 high dose |
| AGMB-129 Low | EXPERIMENTAL | AGMB-129 low dose |
| Ontunisertib | EXPERIMENTAL | Participants will receive single oral dose of ontunisertib |
| [14C]ontunisertib solution for infusion | EXPERIMENTAL | Participants will receive single IV dose of \[14C\]ontunisertib |
| [14C]ontunisertib | EXPERIMENTAL | Participants will receive single oral dose of \[14C\]ontunisertib |
| 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 |
| Name | Type | Description |
|---|---|---|
| Ontunisertib | DRUG | Oral capsule |
| Placebo | DRUG | Matching oral capsule |
| AGMB-129 | DRUG | Oral capsule |
| [14C]ontunisertib | DRUG | IV infusion |
Inclusion Criteria: * Diagnosis of ileal or ileocolonic CD based on clinical and endoscopic or radiological evidence established at least 12 weeks prior to signing the ICF. * Presence of at least 1 endoscopically non-passable ileal stricture. * Present stricture(s) can be naïve or anastomotic, and ...
AGMB-129 is being developed for fibrostenotic Crohn's disease, a form of Crohn's disease in which chronic inflammation leads to narrowing and stiffening of the intestine. It is an investigational small molecule therapeutic from AgomAb Therapeutics NV and has been studied in both healthy volunteers and patients with this condition.
AGMB-129 is developed by AgomAb Therapeutics NV, a biopharmaceutical company whose ticker is AGMB. The company is advancing the compound as a small molecule therapeutic for fibrostenotic Crohn's disease, a gastrointestinal indication, and has sponsored the clinical studies conducted to date.
AGMB-129 is in Phase 2 development. A Phase 2 study called STENOVA evaluated the drug in patients with fibrostenotic Crohn's disease, and a Phase 1 multiple ascending dose study was conducted in healthy participants. Both studies are listed as completed, and the drug remains investigational.
AGMB-129 has been studied in two completed trials. NCT05843578, known as STENOVA, was a Phase 2 study of safety, tolerability, pharmacokinetics and pharmacodynamics in 103 patients with fibrostenotic Crohn's disease across the United States, Austria, Canada, Denmark, Germany, Italy, Poland and Spain. NCT07118878 was a Phase 1 multiple ascending dose study in 30 healthy participants in Belgium.
AGMB-129 is not approved and remains an investigational drug in clinical development. Its two listed studies, a Phase 1 multiple ascending dose trial in healthy volunteers and the Phase 2 STENOVA trial in patients with fibrostenotic Crohn's disease, are both completed. No regulatory approval has been granted for this compound.
AGMB-129 was evaluated in randomized, double-blind, placebo-controlled trials. The Phase 2 STENOVA study enrolled 103 patients with fibrostenotic Crohn's disease, and the Phase 1 multiple ascending dose study enrolled 30 healthy participants. Together the two completed studies included 133 participants, all adults aged 18 years and older.