AdAlta Ltd (ASX:1AD) has made substantial progress 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 final choice of indication for the next clinical trial.
AdAlta is progressing four strategic priorities:
Looking at its achievements so far AdAlta’s CEO and managing director Dr Tim Oldham said: “In the interval between Phase I and Phase II trials of AD-214 we have made significant progress in expanding the value of this asset.
“We now have compelling preclinical data supporting efficacy in kidney fibrosis and have established that AD-214 can be delivered to the lungs via inhalation with mode of action evidence supportive of potential efficacy.
"We have an ongoing collaboration with University of Melbourne for eye fibrosis and a new collaboration with GPCR Therapeutics Inc to evaluate AD-214 in oncology.
“Importantly, we have also made progress identifying manufacturing and formulation improvements. Taking into account the unmet needs in each disease area that AD-214 may address, levels of competition and the time and cost to develop each product option from here, we have elected to focus our own AD-214 efforts on injectable delivery for use in lung, kidney or eye fibrosis.
“We have secured manufacturing and toxicology bookings to prepare us for the next clinical trial in 2024. Other disease areas and routes of administration, including the inhaled version of AD214 remain options available to future partners that can be progressed at low cost to AdAlta.”
Unmet need opportunities abound
By considering the unmet needs in each disease area and the competitive landscape, AdAlta is able to prioritise indications and routes of administration.
The company has considered 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.
It now 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.
The progress being made in Phase II proof of concept studies using the IV version is underpinned by previously completed Phase I studies.
The encouraging progress made it easier to identify opportunities to increase manufacturing yields and reduce liver clearance.
Intravitreal (IVT) AD-214 could address the 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.
There is great potential here to achieve clinical proof of concept via Phase I studies.
GPCR Therapeutics collaboration
1AD has been collaborating with GPCR Therapeutics in the area of oncology, which is now the largest therapeutic market globally.
The collaboration with GCPR is a cost-effective way for AdAlta to progress an oncology pipeline, knowing that the application of CXCR4 antagonists such as AD-214 to treat cancer is attracting significant interest.
Potential partners
AdAlta has now demonstrated the delivery of AD-214 via inhalation and the potential to reduce collagen deposition in cultured lung tissue.
The additional time and cost to complete preclinical development and safety studies for IPF, coupled with the competitive clinical trial landscape has led 1AD to focus resources on injectable formats and make the inhalation program available to lung fibrosis partners to progress.
What’s next
AdAlta has a busy six months ahead. AD-214 milestones now include:
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