The Phase I clinical trial will analyse AGMB-447 to treat idiopathic pulmonary fibrosis. Credit: Rajitha Ruwantha /Shutterstock.com.

Agomab Therapeutics has dosed the first subject in its Phase I clinical trial of inhaled lung-restricted ALK5 inhibitor, AGMB-447, for the treatment of idiopathic pulmonary fibrosis (IPF).

The first-in-human trial has a single ascending dose (SAD) and multiple ascending dose (MAD) portions to evaluate AGMB-447 in healthy participants and subsequently repeated doses will be analysed in IPF patients for two weeks. 

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It will enrol 76 subjects and patients in the UK with tolerability and safety to be evaluated as the primary endpoints.

Systemic and local pharmacokinetics (PK) of the treatment will be analysed as secondary endpoints.

An investigational drug, AGMB-447 is being evaluated for various fibrotic respiratory indications such as IPF.

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It is created to hinder ALK5 in the lung based on quick metabolism through hydrolysis in plasma in order to avert clinically significant systemic exposure.

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Agomab Therapeutics chief development officer Andrea Sáez said: “Starting clinical development for AGMB-447, our second ALK5 asset to enter the clinic, is exciting and a key milestone for Agomab, as it represents a step forward in providing a potential new treatment option for patients with IPF and other fibrotic lung diseases. 

“Thanks to its lung-restricted distribution, AGMB-447 has the potential to potently, yet safely, block TGFβ, a key fibrogenic pathway, selectively in the target tissue.”

In October this year, the company secured $100m in a Series C funding round to progress the development of its fibrosis-focused pipeline.

Fidelity Management & Research Company led the financing round with new investors EQT Life Sciences, Dawn Biopharma, Canaan and current investors taking part.

The funds were intended to be used by Agomab to support the advancement of Phase IIa STENOVA clinical trial of AGMB-129to treat Fibrostenosing Crohn’s disease (FSCD).