..Tag: education series

ADALTA EDUCATION SERIES, Issue Three: Kidney fibrosis

As part of an education series, AdAlta is explaining a range of debilitating diseases, including fibrosis. This post will focus on kidney fibrosis.

🔍 Let’s look at kidney fibrosis

Fibrosis is a condition where excessive scar tissue forms as a result of inflammation or damage, hindering normal functions. The kidney’s main job is to clean your blood, filtering any waste out through your urine. When your kidneys aren’t functioning properly, waste gradually builds up in your body, which can impact your health in many ways. This can lead to ‘chronic kidney disease’, where there is a loss of normal kidney function for more than three months.

Kidney fibrosis, also known as renal fibrosis, may be caused by chronic kidney disease or by the failed or incomplete healing of the kidney tissue after an acute injury. This causes the kidneys to stop working and eventually leads to the need for a transplant.

Kidney fibrosis occurs when there is an imbalance between the formation and degradation of the ‘extracellular matrix’, which is the network of proteins that provides support to the kidneys. As fibrosis progresses, the scar tissue replaces healthy kidney tissue, impairing the proper functioning of the kidneys.

Kidney fibrosis is a progressive process that ultimately leads to end-stage renal disease (ESRD). Treatments can include lifestyle and dietary changes at early stages, to keep blood pressure and blood glucose levels at safe levels. In later stages, treatments can include kidney transplantation or  kidney replacement therapy (dialysis).

AdAlta has demonstrated that the lead candidate, AD-214, has broad anti-fibrotic effects in the lung, kidney and eye. As at October 2023, AD-214 is undergoing a Phase 1 extension clinical study, designed to assess the safety and availability of multiple 10 mg/kg intravenous doses of AD-214, which is the highest dose anticipated to be used in forthcoming Phase II clinical studies. We expect to report interim data by the end of 2023 and full data in early 2024.

Want to learn more?  Visit the AdAlta Fibrosis page

ADALTA EDUCATION SERIES, Issue Two: September is Pulmonary Fibrosis Awareness Month

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