Bridge Biotherapeutics announced that the U.S. Food and Drug Administration (FDA) recently approved the company’s Investigational New Drug (IND) application for BBT-877. The company now has permission to start human clinical trials with this potential therapy for idiopathic pulmonary fibrosis (IPF).
The IND application was submitted in November 2018.
BBT-877 is an inhibitor of the enzyme autotaxin, which is involved in the generation of the lipid (fat) molecule lysophosphatidic acid (LPA). Studies have shown that LPA promotes inflammation and scarring (fibrosis) in the lung, kidney, and liver.
As an inhibitor of autotoxin, BBT-877 is being developed for the treatment of several fibrotic diseases, including IPF.
Now, following this FDA approval, Bridge plans to start a Phase 1 study in the U.S. in January. This clinical trial will test BBT-877’s safety, tolerability, pharmacokinetics (drug trajectory in the body), and pharmacodynamics (drug effects) in healthy volunteers.
The therapy will first undergo a single ascending dose assessment (SAD), giving a rough understanding of the inhibitor’s pharmacokinetics. Next, a multiple ascending dose (MAD) test will assess the inhibitor’s properties after reaching a steady state in the body (when the drug concentration is at equilibrium).
“We are proud of the IND clearance for BBT-877, which has shown a strong potential to be developed as the best-in-class autotaxin inhibitor for IPF treatment,” Gwang-hee Lee, PhD, head of translational research at Bridge Biotherapeutics, said in a press release.
The inhibitor is the company’s second compound with FDA-approved IND for further clinical studies. The first compound, BBT-401, is an inhibitor of the protein Pellino-1, which is involved in ulcerative colitis, a type of inflammatory bowel disease. Bridge Biotherapeutics aims to start Phase 2 clinical studies of the compound this year in the United States.