Avalyn Pharma Inc. · NASDAQ:AVLN
Avalyn Pharma — Technical Presentation (September 2023)
12 slides from Avalyn Pharma's technical presentation, Sep 11, 2023
Slide 1: Nebulised Pirfenidone in idiopathic pulmonary fibrosis (IPF): first look at FVC data
Nebulised Pirfenidone in idiopathic pulmonary fibrosis (IPF): first look at FVC data Dr A West ILD clinical lead Guy’s St Thomas’ NHS Hospitals, London, UK Dr A Lawrence, H Bao, D Nair, C Thompson, Dr F Woodhead 11th September 2023
Slide 2: Conflict of interest disclosure
Conflict of interest disclosure I have the following real or perceived conflicts of interest that relate to this presentation: Affiliation / Financial interest Commercial company Grants/research support: Honoraria or consultation fees: Boehringer Ingelheim, (Avalyn Pharma Inc.) Participation in a co
Slide 3: Content
Content 1. Oral Pirfenidone: Side Effects 2. Nebulised Pirfenidone: Advantages 3. Study Structure 4. Efficacy: First look at FVC data 5. Comparing Side Effects
Slide 4: Oral Pirfenidone: Side Effects
Oral Pirfenidone: Side Effects Potentially dose and duration limiting 40 35 30 25 20 15 10 5 0 Nausea Rash Diarrhoea Dyspepsia Vomiting % Oral Pirfenidone Placebo Noble, PW et al. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials, European
Slide 5: Nebulised Pirfenidone: Advantages
Nebulised Pirfenidone: Advantages 100 mg nebulised vs 801 mg oral • x35 higher peak epithelial lining fluid concentration than oral • <1/15th of the systemic exposure Rubino, CM et al. Effect of food and antacids on the pharmacokinetics of pirfenidone in older healthy adults, Pulmonary Pharmacology
Slide 6: Study Structure
Study Structure Open-Label Extension/Compassionate Use IPF: Randomized to 100mg BID (n=45) IPF: Randomized to 50mg QD (n=46) Transitioned to 100mg by DSMB (n=31) IPF: Rolled over to OLE (n=20) IPF: Rolled over to OLE (n=21) Cohort 1 Cohort 1 New IPF patients Non-IPF ILD (PPF) (n=31) patients (n=28)
Slide 7: Efficacy: First look at FVC data (48 weeks)
Efficacy: First look at FVC data (48 weeks) Change in FVC from Baseline -151.1 mls (SD +/-358.9 mls) -165.5 mls (SD +/-242.6 mls) -235 mls -428 mls 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Nebulised Pirfenidone (cohort 1) Nebulised Pirfenidone (cohort 2) Oral Pirfenidone Placebo Talmadge Jr, EK et al.
Slide 8: Comparing Side Effects
Comparing Side Effects Nebulised Pirfenidone vs Placebo vs Oral Pirfenidone 40 35 30 25 20 15 10 5 0 % Nausea Rash Diarrhoea Dyspepsia Vomiting Oral Pirfenidone Placebo Nebulised Pirfenidone Noble, PW et al. Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinatio
Slide 9: Summary
Summary Nebulised Pirfenidone vs Oral Pirfenidone ➢ x35 higher peak epithelial concentration than oral Pirfenidone ➢ <1/15th systemic absorption ➢ Early data suggests efficacy ➢ Less side effects
Slide 10: Acknowledgements
Acknowledgements Dr Bruce Montgomery, Dr Nazia Chaudhuri, Dr Adam Barczyk, Dr Margaret Wilsher, Dr Peter Hopkins, Dr Ian Glaspole, Dr Tamera Jo Corte, Dr Martina Šterclová, Dr Antony Veale, Dr Ewa Jassem, Dr Marlies Wijsenbeek, Dr Christopher Grainge, Dr Wojciech Piotrowski and Dr Ganesh Raghu, both
Slide 11: Poster: Nebulised Pirfenidone for PPF
Poster: Nebulised Pirfenidone for PPF
Slide 12: International Congress 2023, Milan
INTERNATIONAL CONGRESS 2023 MILAN Italy, 9-13 September
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