Agomab awaits first IPF patient data on inhaled AGMB-447 in late 2026
The Phase 1 trial completed in April 2026 with safety and tolerability as its primary measures, setting up the first IPF patient results for an inhaled, lung-restricted TGF-beta blocker.
Executive Summary
- Agomab Therapeutics has completed its Phase 1 trial of an inhaled ALK5 inhibitor and now awaits the first data from patients with the disease it is designed to treat, rather than healthy volunteers.
- The upcoming readout will show whether a lung-restricted delivery approach can inhibit a fibrosis-driving pathway locally while avoiding the systemic exposure that has limited other candidates in this pathway.
- No other program in clinical testing shares this target in this disease, so the readout will be evaluated against the trial's own safety and tolerability bar rather than a rival's result.
- The trial's enrollment and completion pattern reflect normal Phase 1 protocol updates rather than a program in distress, even as the completion date moved over the course of the study.
The catalyst
Agomab said in a March 26, 2026 disclosure that it expects results from the IPF patient cohort of the Phase 1b study of AGMB-447 later in 2026, with the guided window running from July 1 through December 31, 2026. The company's chief executive, Tim Knotnerus, said in that release that "following the positive healthy subject data for AGMB-447, we look forward to the results of the IPF patient cohort of the Phase 1b study later this year". The trial itself, registered as NCT06181370, reached Completed status on June 23, 2026, with a primary completion date of April 29, 2026 and enrollment of 143 participants. Agomab+1Agomab Receives U.S. Patent for AGMB-447, its Inhaled Lung-restricted Small Molecule Inhibitor ...Mar 26, 2026Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPFNCT06181370
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the trial measures
The study's registered primary endpoints are all safety and tolerability measures: the number of participants with abnormal ECG parameters, abnormal clinical laboratory values, abnormal physical exams, abnormal spirometry (lung function tests), abnormal vital signs, and adverse events. Secondary endpoints track plasma levels of AGMB-447 and its major metabolite, standard pharmacokinetic measures. The trial enrolled both healthy participants (Parts A and B) and IPF patients (Part C), with the IPF cohort required to have a confirmed IPF diagnosis and forced vital capacity of at least 40% of predicted. As a Phase 1 safety and pharmacokinetic study, the design is built to establish tolerability and drug exposure, not efficacy; a decision-grade signal on disease-modifying benefit is not what this trial was built to deliver. NCT06181370Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPFNCT06181370
Enrollment and timing
Enrollment grew from an initial target of 76 to 107 in April 2025, then to 145 by the end of 2025, before settling at an actual enrollment of 143 when the trial completed in June 2026. The primary completion date moved twice during the study, from March 2025 to December 2025, then to June 2026, before the trial completed in April 2026. An enrollment increase in a Phase 1 trial, together with a completion date that lands ahead of its most recent guidance, is a normal pattern for an early-phase study adding a patient cohort, not a signal of distress. NCT06181370Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPFNCT06181370
The competitive frame
AGMB-447 is designed as an inhaled, lung-restricted inhibitor of ALK5 (also known as TGFbetaR1), intended to block a pathway central to fibrosis while limiting exposure elsewhere in the body through local delivery and rapid breakdown in plasma. No other industry trial in clinical testing shares this target in IPF, so there is no direct comparator to benchmark the readout against on mechanism. The broader IPF field includes Phase 2 and Phase 3 programs testing different mechanisms, including PureTech's deupirfenidone, Avalyn Pharma's inhaled nintedanib and pirfenidone formulations, Sunshine Lake Pharma's HEC585, and Boehringer Ingelheim's nerandomilast in interstitial lung disease, none of which target ALK5. Given that mechanistic isolation, the result that would matter most is a tolerability and pharmacodynamic signal in IPF patients clean enough to justify moving into a larger efficacy study, since no validated ALK5-targeted mechanism exists yet in this disease to set a comparative bar. AgomabAgomab Receives U.S. Patent for AGMB-447, its Inhaled Lung-restricted Small Molecule Inhibitor ...Mar 26, 2026
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.