Medication developer AdAlta (ASX:1AD) has reported new data that it claims supports the potential efficacy of its fibrotic treatment, AD-214.
The $11 million market capitalisation company says the data favourably links AD-214 preclinical animal studies and phase one human clinical trial results and provides ‘important’ dose frequency insights.
AdAlta reports the data links CXCR4 receptor occupancy with CXCR4 inhibition to provide direct evidence suggesting that the administration of AD-214 every 2 weeks could be clinically feasible.
“This new data is critically important”
As a result, these findings de-risk and improve the company’s confidence in its AD-214 phase two clinical study dosing regimens.
Speaking on the results, AdAlta Chief Executive Officer (CEO) and Managing Director Dr Tim Oldham said: “This new data is critically important. We have known AD-214 is efficacious in animal models of fibrotic diseases and also that it can at least partially block its target receptor for several days and even weeks after a single IV infusion. What we have not known is whether we could replicate the therapeutic effect seen in animals at these levels of receptor occupancy and hence at dosing frequencies acceptable in humans.
For the first time, we have been able to show that we can maximally inhibit a key fibrotic process with as little as 60% receptor occupancy and that meaningful inhibition can be achieved at much lower levels. This supports the hypothesis that AD-214 may be able to be dosed at a clinically convenient frequency of no more than every 2 weeks. This information is also extremely valuable for determining appropriate dosing for AD-214 phase two clinical studies.
Linking a clinically measurable parameter with efficacy answers a question commonly asked by potential commercial partners and substantially reduces the risk of phase two studies. The completion of these difficult experiments is a credit to our in-house scientific team.”
AdAlta is a clinical stage medication developer headquartered in Melbourne, Victoria, and is actively using its proprietary i-body technology platform to solve challenging medication targeting problems and generate a ‘promising’ new class of single-domain antibody protein therapeutics.
The company had $5.57 million cash at hand at the end of March 2023, as stated in its latest quarterly report released on 28 April, though it said in May it was on track to complete a $3.15 million rights issue.