Idiopathic pulmonary fibrosis digest - 2021

Idiopathic pulmonary fibrosis digest - 2021

Avalyn Pharmaceuticals’ inhaled pirfenidone showed promising Phase 1/2 data

Avalyn Pharmaceuticals reported results of Phase 1/2 inhaled Pirfenidone in idiopathic pulmonary fibrosis

AP01 (Aerosolized Pirfenidone, Collagen and cytokine inhibitor) – Avalyn Pharmaceuticals

  • 24-week data of a Phase 1/2 clinical study of two dose regimens of AP01 in patients with IPF at the ISAM conference
  • Trial details: ATLAS; Phase 1/2 in IPF; N= 91; AP01 50 mg OD or 100 mg BD for 72 weeks; Primary outcomes: Safety and tolerability, AE, change from pre dose FVC %; Active, not recruiting; Location: Australia, EU
  • Results:
    • During the first 24 weeks, the high dose group had, on average, no loss of lung function as measured by forced vital capacity (FVC)
    • The low dose group had a progressive loss of lung function
    • The differences in FVC between the two groups was statistically significant (p=0.049)
    • AP01 was safe and well tolerated at both doses
    • Flu-like symptoms and GI adverse events mostly attributed to oral pirfenidone were seen in less than 10% of patients treated with AP01
    • AEs with a frequency of greater that 10% were rash 18%, upper respiratory tract infection 18%, cough 24%
    • Most subjects have opted to continue in the 12-month extension
  • Longer term efficacy and safety data will be presented at an upcoming scientific meeting (For full story click here)

Efficacy and safety data for aerosolized pirfenidone in 91 patients over 24 weeks looks promising

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CI Scientists Commentary:

  • Oral pirfenidone is an approved treatment option for IPF. But its low potency requires higher dose administration which is associated with GI side effects and photosensitivity and leads to treatment discontinuations
  • Avalyn Pharma has an aerosolized option for pirfenidone delivered via the PARI investigational eFlow nebulizer
  • With positive results from the Phase 1/2 trial, Avalyn Pharma’s plans for Phase 3 trial initiation can be expected in 2021
  • Along with aerosolized pirfenidone, Avalyn is also developing AP02 (aerosolized nintedanib) to overcome issues with its oral administration
  • Avalyn Pharma secured $35.5 Million (Series B Financing, Apr’20) in addition to $62 Million Series A Financing (May’17) to help its Phase 3 launch and Phase 1 trial initiation for AP02
  • FDA granted orphan drug designation for AP01

– Dr. Kowndinya, CI Scientists

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