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AGMB-447 · 2 trials · 2 indications
To evaluate the effect of AGMB-447 on lung function in participants with IPF, compared to placebo
To evaluate the safety and tolerability of AGMB-447 in terms of AE at every visit
To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of abnormal ECGs at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of vital signs at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of physical exams at every visit
To evaluate the safety and tolerability of AGMB-447 in terms of spirometry at every visit
| Arm | Type | Description |
|---|---|---|
| AGMB-447 | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | Matching Placebo |
| Name | Type | Description |
|---|---|---|
| AGMB-447 | DRUG | Administered via inhalation |
| Placebo | DRUG | Matching placebo administered via inhalation |
Inclusion Criteria: * Participants aged ≥40 years at the time of signing the ICF. * Diagnosis of IPF within 7 years prior to the screening visit, confirmed by centrally reviewed high-resolution computed tomography (HRCT) of the chest (performed during screening period). * Confirmed pulmonary functi...
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AGMB-447 is an investigational small molecule being developed by AgomAb Therapeutics NV for idiopathic pulmonary fibrosis, or IPF. It is a Phase 1 asset in the respiratory therapeutic area and has been studied in a completed first-in-human trial in healthy participants and participants with IPF.
AGMB-447 is being developed as a treatment for idiopathic pulmonary fibrosis, a progressive scarring disease of the lungs. It is not approved for any use and remains investigational. A Phase 2 trial in participants with IPF is planned but has not yet begun recruiting.
AGMB-447 targets ALK5, a receptor. ALK5 is a receptor kinase, and AGMB-447 is a small molecule designed to act on it. This target class places the drug among compounds that modulate receptor signaling rather than acting through an antibody or cell-based mechanism.
AGMB-447 is being developed by AgomAb Therapeutics NV, which trades under the ticker AGMB. The company is the sponsor of the clinical program for the drug in idiopathic pulmonary fibrosis.
AGMB-447 is in Phase 1 development. A Phase 1 study in healthy participants and participants with IPF has been completed, and a Phase 2 trial in idiopathic pulmonary fibrosis is listed as not yet recruiting. The drug is investigational and has not been approved by the FDA.
AGMB-447 has been studied in NCT06181370, a completed Phase 1 trial assessing safety, tolerability, pharmacokinetics and pharmacodynamics in healthy participants and participants with IPF, which enrolled 143 participants in the United Kingdom. A Phase 2 trial, NCT07862634, is planned in participants with IPF and is not yet recruiting.