Angion Biomedica Cleared for Phase 1B Trial of ANG-3070 in IPF
The U.S. Food and Drug Administration (FDA) has given permission for Angion Biomedica to launch a Phase clinical 1b trial to test its experimental anti-fibrotic medication ANG-3070 in people with idiopathic pulmonary fibrosis (IPF).
Angion is planning to launch the trial soon and expects that results will be available before the year’s end.
The FDA’s decision to accept Angion’s investigational new drug application for ANG-3070 in IPF is “an important milestone for Angion,” John Neylan, the company’s executive vice president and chief medical officer, said in a press release.
“Results from this study will assist us in designing and enrolling a Phase 2 trial in IPF, which we expect to initiate in 2023,” Neylan said.
The upcoming trial aims to enroll approximately 20 people with IPF. The study will be open to patients who have never received treatment specifically for IPF and also to those who have discontinued or refused treatment with Esbriet (pirfenidone) or Ofev (nintedanib), both anti-fibrotic medications approved to treat IPF.
A crossover design will be used for the study: For the first 10 days, participants will be randomly assigned to take one of two doses of ANG-3070 (300 mg twice per day, or 500 mg once per day) or a matching placebo. In a second 10-day treatment period, participants originally given a placebo will be treated with ANG-3070, and those initially given the experimental medicine will instead receive a placebo. There will be a five-day “washout” period between the two 10-day treatment periods.
The main goal of the trial is to assess the safety of ANG-3070. The investigational treatment’s pharmacological profile will also be examined.
ANG-3070 is an oral molecule designed to inhibit the activity of certain tyrosine kinase receptors, a class of proteins that helps cells sense external signaling molecules. Specifically, ANG-3070 blocks the activity of four proteins that are involved in the formation of scar tissue, or fibrosis, including platelet-derived growth factor receptor alpha and beta (PDGFR alpha and PDGFR beta), and discoidin domain receptors 1 and 2 (DDR1 and DDR2).
Recent results from a number of in vitro experiments — studies conducted in cells grown in the lab — have shown that ANG-3070 can reduce the growth and the scar-promoting activity of fibroblasts, which are connective tissue cells centrally involved in fibrosis.
The therapy also has shown promise in animal models (in vivo) and was well-tolerated in an early study in healthy volunteers. ANG-3070 is being tested in people with kidney disease in an Angion-sponsored Phase 2 study called JUNIPER (NCT04939116).
“These in vitro studies provide further demonstration of ANG-3070’s potential for clinical activity in IPF,” Neylan said. “These data complement the significant body of existing in vivo studies showing activity of ANG-3070 in both kidney and lung fibrosis, enabling us to advance a robust clinical development program for ANG-3070 in both primary proteinuric kidney diseases in our Phase 2 JUNIPER trial as well as in IPF.”