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(ANGN) – Angion Biomedica Shares Moving Higher On Encouraging Results From Early Stage Trial Of Fibrotic Disease Candidate

(ANGN) - Angion Biomedica Shares Moving Higher On Encouraging Results From Early Stage Trial Of Fibrotic Disease Candidate

  • Angion Biomedica Corp (NASDAQ: ANGN) has announced positive results from its Phase 1 study in healthy volunteers for ANG-3070 for fibrotic diseases. 
  • In the 97-volunteer trial, 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.
  • Pharmacokinetic data supportive of potential once-daily oral dosing for ANG-3070
  • The reported (non-serious) adverse events were primarily seen at higher doses, 600 mg administered once daily and 500 mg. These adverse events included nausea, abdominal cramps, and diarrhea and were considered mild to moderate in severity. 
  • The Company hs 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.
  • The 100-subject Phase 2 trial will investigate three dose levels of ANG-3070 compared to placebo. 
  • The study’s primary endpoint is the percentage change in 24-hour urinary protein excretion at the end of 12 weeks of dosing. 
  • Enrollment will start in 2H of 2021.
  • ANG-3070 is a tyrosine kinase receptor inhibitor developed to treat fibrotic diseases, particularly in the lung and kidney.
  • Price Action: ANGN shares are up 14.3% at $11.99 during the premarket session on the last check Tuesday.