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Also known as AGMB-129
Ontunisertib · 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 ...
Ontunisertib is an investigational small molecule being developed for fibrostenotic Crohn's disease, a form of Crohn's disease characterized by intestinal narrowing and fibrosis. It is currently in Phase 2 clinical development and has not been approved by the FDA. It is being studied in patients with this condition.
Ontunisertib targets ALK5, also known as transforming growth factor beta receptor type I. By inhibiting ALK5, the drug is designed to interfere with TGF-beta signaling, which is implicated in fibrosis and stricture formation in fibrostenotic Crohn's disease. This mechanism is under investigation in clinical trials.
Ontunisertib is being developed by AgomAb Therapeutics NV, a biopharmaceutical company. The company's ticker symbol is AGMB. AgomAb is focused on developing therapies for fibrotic and inflammatory diseases, and Ontunisertib is its investigational small molecule for fibrostenotic Crohn's disease.
Ontunisertib is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 program includes a randomized, double-blind, controlled trial in patients with fibrostenotic Crohn's disease.
Ontunisertib is being evaluated in two active clinical trials. The Phase 2 NOV-ERA trial (NCT07683325) is assessing its efficacy and safety compared to placebo in patients with fibrostenosing Crohn's disease, enrolling 320 participants in the United States. A Phase 1 human mass balance study (NCT07672574) is also recruiting healthy male volunteers in the United Kingdom.
Ontunisertib has received Fast Track designation from the FDA. This designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The drug remains investigational and is currently in Phase 2 clinical testing.