News

IPF treatment AGMB-447 granted FDA orphan drug status

AGMB-447, an inhaled treatment for idiopathic pulmonary fibrosis (IPF) now being tested in a Phase 1 clinical trial, has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA). The FDA gives this designation to therapies that may improve care for people with rare diseases,…

Lixudebart for IPF receives orphan drug status from FDA

The U.S. Food and Drug Administration (FDA) has granted its orphan drug designation to Alentis Therapeutics’ antibody-based therapy lixudebart (ALE.F02) for idiopathic pulmonary fibrosis (IPF). Orphan drug designation is given to support the accelerated development of investigational treatments for rare diseases, defined as those affecting fewer than 200,000…

Study: ENV-101 improves IPF lung function, reverses fibrosis

Endeavor BioMedicines’ ENV-101 improved lung function and reversed key signs of lung scarring in people with idiopathic pulmonary fibrosis (IPF), according to data from a completed Phase 2a trial. The results, which also showed the treatment had an acceptable tolerability profile, were presented in a late-breaking oral…

It’s 2K and counting for PF patient registry, foundation says

The Pulmonary Fibrosis Foundation (PFF) said its two-year-old patient Community Registry achieved a “significant milestone” in its goal to drive more research and discoveries in pulmonary fibrosis (PF) and interstitial lung diseases (ILDs), reaching its 2,000th participant. The registry opened in July 2022 to provide scientists with…

Bexotegrast reverses signs of IPF lung scarring in Phase 2a trial

Pliant Therapeutics’ bexotegrast reversed the signs of lung scarring, while improving lung function and easing cough severity in people with idiopathic pulmonary fibrosis (IPF), according to top-line data from a small Phase 2a imaging trial. Using positron emission tomography (PET) scans, researchers at Massachusetts General Hospital were able…

$132.5M raised to advance ENV-101’s clinical development for IPF

Endeavor BioMedicines has raised $132.5 million toward the clinical development of its pipeline programs, including ENV-101, an investigational oral treatment for idiopathic pulmonary fibrosis (IPF). Results from a recent Phase 2a trial (NCT04968574) showed ENV-101 was generally well tolerated, reduced tissue scarring, or fibrosis, and improved lung…

Enrollment complete for Phase 2b trial testing LYT-100 in IPF patients

Enrollment has been completed for a Phase 2b trial that’s testing LYT-100 (deupirfenidone), PureTech Health’s experimental therapy for idiopathic pulmonary fibrosis (IPF). The trial, called ELEVATE IPF (NCT05321420), is assessing the safety, efficacy, and dosing regimen of LYT-100 in 240 adults with IPF, compared with a placebo.