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news.The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Agomab Therapeutics’ AGMB-447, an inhaled small molecule ALK5-inhibitor, for treating idiopathic pulmonary fibrosis (IPF).
Currently, AGMB-447 is being assessed in an ongoing Phase I clinical trial as a potential treatment for IPF. Credit: kalhh from Pixabay.
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Currently, AGMB-447 is being assessed in an ongoing Phase I clinical trial as a potential treatment for IPF.
The single-centre, integrated trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AGMB-447.
The trial has three parts: a double-blind, randomised, placebo-controlled single ascending dose (SAD) study in healthy participants (Part A), a multiple ascending dose (MAD) study (Part B), and a multiple dose study in IPF patients (Part C).
Each part of the study is designed to assess the varying doses of AGMB-447 when administered via a nebulizer.
The ODD programme of FDA encourages the development of treatments for rare diseases, defined as conditions affecting fewer than 200,000 individuals in the US.
This status will offer various benefits for Agomab, including market exclusivity upon product approval, as well as financial incentives like tax credits for clinical research expenses.
AGMB-447 is still an investigational drug and has not yet been approved by any regulatory authority.
Agomab Therapeutics chief medical officer Philippe Wiesel said: “Receiving orphan drug designation from the FDA provides further support that AGMB-447’s mechanism of action has the potential to achieve meaningful therapeutic benefits to IPF patients.
“As we progress through our ongoing first-in-human Phase I trial, we look forward to evaluating the data from the single ascending dose and multiple ascending dose evaluation of AGMB-447 in healthy subjects and IPF patients.”
