..Author: Lauren Byrne

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

i-bodies and beyond with AdAlta’s Tim Oldham and The Market Bull

The Market Bull’s Ben Kosterich interviews Dr Tim Oldham, CEO and Managing Director of AdAlta (ASX: 1AD). Tim talks about the history of the company and what i-bodies are. Tim explains in depth AD-214 and the drug’s application for a range of fibrosis treatments such as lungs, liver, eyes and kidney. AdAlta is also developing the CAR-T treatment with Carina Biotech which could revolutionise cancer tumour treatment.

Click below to watch the interview.

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

ADALTA EDUCATION SERIES, Issue One: Fibrosis

As part of a health education project, this post is the first in a series by AdAlta designed to explain some of the debilitating diseases that impact the population, with no known cures.

AdAlta (ASX: 1AD) is a drug discovery, development and commercialisation company, focused on generating a pipeline of next generation therapeutics to treat challenging diseases in fibrosis and oncology.

Our first series will cover fibrosis. September is Pulmonary Fibrosis Awareness Month. Pulmonary Fibrosis has a literal translation of “Scarring of the Lungs”, so our next blog will cover lung fibrosis in further detail.

🔍 What is fibrosis?

Fibrosis is a condition where excessive scar tissue forms as a result of inflammation or damage, hindering normal functions. It can cause scarring of vital organs such as the lungs, eyes, liver, kidney, heart and skin. The damage cannot be repaired and leads to eventual organ failure.

Impacts

💔 It has been estimated that fibrosis is prevalent in 45% of all diseases.

📊 Fibrotic diseases affect millions of people globally.

💸 Treating fibrosis-related conditions costs billions of dollars annually.

Fibrosis doesn’t just affect organs; it impacts lives! It can cause shortness of breath, fatigue, decreased mobility and leads to organ failure, severely diminishing one’s quality of life.

There is currently no clinically satisfactory therapeutic approach to fibrosis.

AdAlta is using its i-body technology to create a pipeline of new drugs, with an initial focus on treating fibrotic diseases.

🔍 What is an i-body?

An i-body is a human protein that belongs to the class of ‘next generation’ antibodies. It has a long loop that allows it to bind with a target that is causing disease. An i-body is much smaller than traditional monoclonal antibodies. Its unique structure provides a competitive advantage, as it can reach places and bind to drug targets that existing drugs can’t.

🔍 What is a Drug Target?

A Drug Target is the protein or receptor on a cell that a drug binds to, producing a therapeutic effect. The i-body binds with high affinity (the strength of interaction) to a Drug Target, reducing the off-target side effects commonly experienced with small molecule drugs. This also provides access to Drug Targets that traditional monoclonal antibodies can’t reach.

The i-body can be customised to increase the duration of time a drug stays in the body. Our next post will further explain lung fibrosis.

Want to learn more? Visit AdAlta’s fibrosis page.

AdAlta investor briefing – progress of AD-214 Phase I extension study

On 10 August 2023, AdAlta’s CEO and Managing Director, Dr Tim Oldham provided an update on lead drug AD-214, including the dosing of first participants in the Phase I extension study, recent data demonstrating potential efficacy of clinically convenient doses and partnering progress.

The AD-214 Phase 1 extension study will generate valuable data to inform and de-risk the design of the future AD-214 Phase II study, and progress partnering discussions.

During the webinar, Dr Oldham also discussed the unmet need for improved treatments for lung fibrosis patients for whom AD-214 is being developed. He highlighted Long Kayak for Lungs 2, the latest initiative by IPF survivor Bill Van Nierop to raise awareness of and funds for research into IPF, which AdAlta is supporting.

Click below to watch:

AdAlta talks to Bulls N’ Bears on developments for fibrosis sufferers

AdAlta’s CEO and Managing Director, Dr Tim Oldham spoke to Bulls N’ Bears’ Matt Birney on the development of its i-body platform technology, and more specifically, progress for lead product AD-214, for the treatment of fibrotic diseases including Idiopathic Pulmonary Fibrosis (IPF).

Dr Oldham explains the severe and progressive impact of fibrotic diseases on organ function and how the two current drug treatments for IPF have limited effectiveness combined with severe side effects.

AdAlta’s AD-214 is taking a novel approach by targeting a different biological pathway to treat fibrosis. New data has demonstrated that we can achieve an effective outcome when dosing every two weeks. This is positive news for AdAlta, potential patients and partners, as AdAlta prepares for Phase II trials. Listen below to learn more.

AdAlta participates in US Emerging Growth Conference 13 July, 2023

AdAlta’s (ASX: 1AD) CEO and Managing Director, Dr Tim Oldham presented at the virtual Emerging Growth Conference on Thursday 13 July. This small cap conference is designed to present emerging growth companies to investment communities across the US and the world.

Dr Oldham’s presentation provided an overview of AdAlta and the Company’s pipeline and partnering opportunities, following the release of a positive quarterly report. Click below to watch the presentation and the Q&A session. The highlights include:

  • New data released 7 July favourably links AD-214 preclinical animal studies and Phase I human trial results with efficacy for the first time, de-risking the clinical dosing schedule
  • A highly productive BIO2023 partnering conference progressed partnering interest and discussions in AD-214, plus two additional opportunities
  • The successful completion of the recent Rights Offer, raising $1.28 million with an additional $1.87 million committed in an oversubscribed shortfall facility
  • The Phase I extension study for AD-214, to reduce the duration and cost of Phase II recently received ethics approval and is starting soon

AdAlta presents at TCN Emerging ASX Gems conference

AdAlta Limited (ASX: 1AD) CEO and Managing Director, Dr Tim Oldham presented at The Capital Network (TCN) Emerging ASX Gems investment conference livestream on 7 July 2023.

Dr Oldham’s presentation provides an introduction to, and an explanation of AdAlta’s powerful i-body discovery platform, and the next generation therapeutics in development or in the pipeline, to treat fibrotic disease, oncology and cellular immunotherapy.

Click below to hear an update on AdAlta’s pipeline programs. Dr Oldham highlights the enhanced partnering opportunity flowing from new data released on 7 July, that favourably links AD-214 preclinical animal studies and Phase I human trial results, supporting efficacy at clinically viable dose regimens.