As part of an education series, AdAlta is explaining a range of debilitating diseases, including fibrosis. Given that September is Pulmonary Fibrosis Awareness Month, this post will focus on fibrosis of the lungs, and more specifically, Pulmonary Fibrosis.
🔍 More on lung fibrosis
Fibrosis is a condition where excessive scar tissue forms as a result of inflammation or damage, hindering normal functions. A specific form of lung fibrosis is Idiopathic Pulmonary Fibrosis (IPF), where tissues deep in the lungs experience a build-up of fibrous connective tissues which cause the walls of the lungs to thicken, resulting in a progressive decline in lung function, and shortness of breath. Sufferers often feel like they are in danger of suffocating, as they are constantly short of breath.
🔍 Fibrosis facts
- There is no cure for IPF
- >490,000 people live with IPF globally
- In Australia, IPF affects about 5,000 people
- While still a rare disease, in the US >40,000 people die every year from IPF
- The median survival after diagnosis is 3.8 years
- 88% of sufferers are aged 55 or older
- IPF is a US$4.3b industry
- There are two current therapies, with limited effectiveness and serious side effects
Because this condition affects less than one in 20,000 patients within the USA or Europe, any drugs addressing it are called orphan drugs.
In 2021, AdAlta was granted “Orphan Drug Designation” by the FDA in the US. This allows for new drug application fee waivers, a potentially faster route to market and an additional seven years of exclusivity once a drug is on market.
AdAlta’s solution: AD-214 is currently undergoing a Phase I extension study, with the goal of confirming the safety and dosing schedule, reducing the duration and cost of Phase II studies.
Current status of AD-214:
- Pre-clinical efficacy in multiple animal models of fibrotic disease = multiple indication potential
- Manufacturing process established
- Phase I successfully completed = well tolerated, evidence of target binding
- Strong intellectual property protection = asset protection to 2036
- Regulatory advantages = US FDA Orphan Drug Designation
Want to learn more? Visit AdAlta’s fibrosis page