Saturday, 04 April 2020

Bridge Bio receives FDA ODD for IPF drug

17 January 2019 | News

BBT-877, a potent best-in-class Autotaxin (ATX) inhibitor deregulates ATX, the enzyme found to be engaging in inflammation and fibrosis by generating the lipid signaling molecule.

image credit- americangene.com

image credit- americangene.com

Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) to BBT-877, a drug candidate under development for Idiopathic Pulmonary Fibrosis (IPF) treatment.

BBT-877, a potent best-in-class Autotaxin (ATX) inhibitor deregulates ATX, the enzyme found to be engaging in inflammation and fibrosis by generating the lipid signaling molecule. The early-stage compound of BBT-877 had been originally discovered by LegoChem Biosciences and has been under the development process by the lead of Bridge Biotherapeutics since the company acquired the worldwide exclusive right for further developments in 2017.

Bridge Biotherapeutics will commence a Phase 1 study of BBT-877 in the U.S. next month to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug candidate in healthy volunteers. The planned study will be performed in two phases, a Single Ascending Dose (SAD) phase with 5 cohorts and a Multi Ascending Dose (MAD) phase with 3 cohorts. The estimated primary completion date is currently expected in late 2019.

Sign up for the editor pick and get articles like this delivered right to your inbox.

Editors Pick
+Country Code-Phone Number(xxx-xxxxxxx)


Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account