Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset

07 Jun 2024
www.pharmaceutical-technology.com
Phase 1Orphan DrugClinical ResultPhase 2Drug Approval
Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset
Preview
Source: Pharmaceutical Technology
Agomab is now eligible for market exclusivity and a range of financial incentives. Image credit: Shutterstock / HammadKhn.
Six months after kicking off a Phase I trial for idiopathic pulmonary fibrosis (IPF) treatment AGMB-447, Agomab Therapeutics has now secured a US Food and Drug Administration (FDA) orphan drug designation for the asset.
Recommended Buyer's Guides
Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset
Preview
Source: Pharmaceutical Technology
Buyer's Guide
Leading Guide to Packaging Materials, Containers and Containment Services for the Pharmaceutical Industry
Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset
Preview
Source: Pharmaceutical Technology
Buyer's Guide
Leading Guide to Compliance Software for the Pharmaceutical Industry
The Belgium-based biotech will now be in line for tax credits for US-based clinical trials and, if the therapy is approved, the potential for seven years of market exclusivity in the designated indication.
IPF is a rare, chronic lung disease that affects the air sacs – called alveoli – in the lungs. The condition is characterised by thickening of lung tissue that becomes stiff, causing breathing difficulties. It is not known what causes the disease, though the risk is increased with smoking and a family history of IPF.
There are currently two FDA-approved drugs for IPF, Boehringer Ingelheim’s Ofev (nintedanib) and Genentech’s Esbriet (pirfenidone). Ofev is a tyrosine kinase inhibitor whilst Esbriet targets TGF-beta, a chemical mediator that plays a role in development of fibrosis.
Agomab has gone down a similar route to Genentech, with AGMB-447 blocking the action of the TGFβ type 1 receptor. Agomab’s USP is that AGMB-447, which is inhaled, inhibits the TGFβ type 1 receptor, also known as ALK5, only in the lung. The biotech has achieved this by designing the drug to be rapidly metabolised through hydrolysis in the plasma, preventing exposure throughout the whole body.
See Also:The tiny pills that may send shockwaves across immunology
Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset
Preview
Source: Pharmaceutical Technology
Roche’s PI3K inhibitor secures breakthrough status in breast cancer
Agomab wins FDA orphan drug status for idiopathic pulmonary fibrosis asset
Preview
Source: Pharmaceutical Technology
Agomab is evaluating AGMB-447 in a placebo-controlled Phase I trial that aims to enrol 76 patients with IPF. Participants will either receive a single dose or multiple doses of AGMB-447, the latter treatment will occur in two cohorts over seven days or 14 days. The randomised trial has primary endpoints comprising safety assessments up to eight weeks after therapy. Secondary endpoints include pharmacokinetic measurements. The biotech dosed the first patient in December 2023.
Agomab’s chief medical officer Philippe Wiesel said: “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.”
Agomab secured $100m in Series C financing in October 2023. In a statement at the time, the biotech said it would use part of the funds to progress Crohn’s disease candidate AGMB-129 – also an ALK5 inhibitorALK5 inhibitor – through Phase II trials.
Agomab’s designation comes only a few weeks after Alentis Therapeutics won orphan drug status for its candidate lixudebart in IPF. In the same announcement as its orphan drug designation, Alentis reported positive safety results from a Phase I trial evaluating lixudebart in IPF patients.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.