Benzinga | Aug 3, 2021 08:36AM EDT

Angion Earlier Today Reported Positive Results from Phase 1 Healthy Volunteer Study for ANG-3070 and FDA Authorization to Initiate Phase 2 Trial in 2021

Angion Biomedica Corp (NASDAQ:ANGN), a late-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel small molecule therapeutics to address acute organ injuries and fibrotic diseases, today announced positive results from its Phase 1 study in healthy volunteers for ANG-3070, a novel oral tyrosine kinase receptor inhibitor (TKI) being developed for the treatment of fibrotic diseases. Angion also announced the FDA's acceptance of an IND application supporting the initiation of a Phase 2 trial in patients with primary proteinuric kidney diseases in 2021. Additionally, the Company announced it will host a Virtual Fibrosis R&D Day on September 20, 2021.

Key findings from the ANG-3070 Phase 1 healthy volunteer study included:

* ANG-3070 achieved drug exposures in humans exceeding exposures in which activity was demonstrated in animal models of proteinuric kidney diseases

* ANG-3070 demonstrated a favorable safety and tolerability profile, including with respect to gastrointestinal side effects, which was encouraging given the well-recognized incidence and severity of these side effects in approved TKIs

* Pharmacokinetic data supportive of potential once-daily oral dosing for ANG-3070

The Phase 1 study was a randomized, double-blind, and placebo-controlled study in healthy volunteers conducted in Australia to assess the safety, tolerability, pharmacokinetics, and food effect of ANG-3070 dosed orally. The study consisted of both single-and multiple-ascending dose cohorts and enrolled 97 healthy volunteers, with 72 volunteers receiving ANG-3070 and 25 volunteers receiving placebo. Doses studied in the study ranged from 50mg to 600mg and included both once daily and twice daily regimens.

"We are very pleased with the results from the Phase 1 healthy volunteer study of ANG-3070," said John F. Neylan, M.D., Angion's Chief Medical Officer. "The data from this study surpassed expectations, where ANG-3070 exposures seen in the study exceeded the levels of drug exposure needed to demonstrate activity in our animal models of kidney disease. The favorable safety and PK profile seen in the study allows us the flexibility to use a range of dose levels as we explore the efficacy of ANG-3070 in a Phase 2 trial in patients with primary proteinuric kidney diseases."

ANG-3070 demonstrated a favorable safety and tolerability profile in the study. There were no serious adverse events reported at any dose schedule or level. The reported (non-serious) adverse events were seen mostly at higher doses, 600 mg administered once-daily and 500 mg administered twice-daily over two weeks. These adverse events included nausea, abdominal cramps, and diarrhea, and were considered mild to moderate in severity. This was encouraging given the well-recognized incidence and severity of these side effects in approved TKIs.

The international Phase 2 clinical trial of ANG-3070 will be a randomized, double-blind, and placebo-controlled study of ANG-3070 in approximately 100 patients with primary proteinuric kidney diseases, including IgA nephropathy and focal segmental glomerulosclerosis (FSGS). The study will investigate three dose levels of ANG-3070, 200mg and 400mg once a day and 300mg twice a day, compared to placebo. The primary endpoint of the study is the percentage change in 24-hour urinary protein excretion at the end of 12 weeks of dosing. This exploratory Phase 2 trial is expected to enroll its first patient in the second half of this year.