Angion Plans To Ask FDA for OK to Start Testing ANG-3070 in Patients
Angion Biomedica plans to ask the U.S. Food and Drug Administration (FDA) for permission to start testing its experimental therapy ANG-3070 in people with idiopathic pulmonary fibrosis (IPF), the company announced.
ANG-3070 is an oral medication designed to block the activity of multiple protein receptors that contribute to the development and progression of tissue scarring, or fibrosis, in IPF and other diseases. Specifically, ANG-3070 blocks PDGFR alpha and PDGFR beta, as well as DDR1 and DDR2.
According to data shared by Angion at an investor’s presentation last month, treatment with ANG-3070 reduced fibrosis in three different animal models of lung fibrosis, as well as in kidney fibrosis models.
Angion has already completed a Phase 1 trial that investigated the safety and pharmacological properties of multiple doses of ANG-3070, given with or without food, in healthy volunteers.
Pharmacological data showed it was absorbed within an hour or two if taken under fasting conditions. Taken with food, absorption took about three to four hours.
Additional data showed the experimental therapy had a mean half-life of 15–21 hours, suggesting ANG-3070 may be amenable to dosing once or twice a day. Half-life is the time it takes for a specific compound’s levels to drop to half of what was administered; the longer the half-life, the longer it takes for a compound to be fully eliminated from the body.
Exposure to the medication was similar regardless of whether ANG-3070 was given with food, and exposure levels were similar or higher in people compared with the relative levels that achieved therapeutic effects in animal models. Yet, they still remained far below the levels that caused any toxicity in animal models.
The medication was generally safe and well tolerated in the Phase 1 study. There were no serious side effects reported in any of the tested doses. The most commonly reported side effects among the 72 participants given ANG-3070 were gastrointestinal problems, mainly nausea and/or diarrhea. Nausea was less common when it was given with food.
Angion is currently conducting a Phase 2 study called JUNIPER (NCT04939116) to evaluate ANG-3070 in people with kidney disease.
Before the end of this year, the company plans to submit an investigational new drug (IND) application to the FDA requesting permission to begin clinical testing in people with IPF. The Phase 2 study aims to enroll IPF patients who refused, have failed to respond, or had to discontinue prior treatment due to side effects. The company anticipates testing the effects of several doses of ANG-3070 on patients’ lung function, which will likely be assessed after six and 12 months.
“In 2022, we are focused on advancing Angion’s lead clinical development candidate ANG-3070 for the treatment of patients with primary proteinuric kidney diseases and continuing the enrollment of JUNIPER, our Phase 2 dose-finding study in focal segmental glomerular sclerosis and IgA nephropathy patients,” Jay Venkatesan, MD, chairman and CEO of Angion, said in a press release.
“We also plan to advance ANG-3070 for the treatment of idiopathic pulmonary fibrosis and to file an IND by the end of the year in this population in need of additional approved therapies,” Venkatesan said.