AdAlta expands disease areas for AD-214 applications

Posted: 3 November

AdAlta Ltd (ASX:1AD) has made substantial progress in expanding the potential disease areas (indications) and routes of delivery for AD-214 – its lead program and a first in class antifibrotic.

The applications of AD-214 have now been expanded to include lung, kidney and eye fibrosis, and cancer – all major areas of unmet need with substantial commercial interest.

The company will prioritise injectable delivery of AD-214 for lung, kidney or eye fibrosis for development, while seeking partnerships to progress other applications.

Pre-clinical data and partnering discussions over the next six months are designed to guide the final choice of indication for the next clinical trial.

AdAlta is progressing with four strategic priorities:

1. Prioritise clinical development of AD-214 for lung, kidney and eye fibrosis. Pre-clinical data and partnering discussions over the next six months to guide final choice of indication for next clinical trial.
2. Progress injectable (intravenous/IV for lung, kidney fibrosis and intravitreal/IVT for eye fibrosis) routes of administration.
3. Continue investment in manufacturing and formulation improvement strategies.
4. Leverage progress in the development of an inhaled format of AD-214 for partnering for lung fibrosis.

Several disease area opportunities – all with unmet need

To prioritise indications and routes of administration, AdAlta considered the unmet needs in each disease area and the competitive landscape. Also considered was the data, available or pending, supporting use of AD-214 in each indication, and the time and cost to progress each indication and route of administration to clinical proof of concept.

AdAlta has compelling pre-clinical data using the IV version of AD-214 in lung and kidney fibrosis. Like lung fibrosis, kidney fibrosis is an area of high unmet need with a less competitive landscape. Progress to Phase II proof of concept studies using the IV version is underpinned by previously completed Phase I studies and encouraging progress made identifying
opportunities to increase manufacturing yields and reduce liver clearance.

Intravitreal (IVT) AD-214 could address an attractive, very underserved market in eye fibrosis with significant early stage partnering interest and a more favourable competitive landscape. Previous encouraging pre-clinical studies using the earlier version of the product, AD-114, are being replicated and extended using AD-214, with results due in the next six months.

IVT AD-214 (intravitreal) could be progressed separately to IV AD-214 (intravenous) through engagement with partners, or by AdAlta directly. It has the potential to achieve clinical proof of concept via Phase I studies.

What’s next

AdAlta has a busy six months ahead. AD-214 milestones now include:

1. Start of manufacturing of AD-214 for extended-dose toxicology studies.
2. Additional pre-clinical results in eye and kidney fibrosis.
3. Further details on clinical program indication and design.
4. Continuation of partnering outreach for IV AD-214 in lung and kidney fibrosis.

Find out more.