AdAlta completes patient recruitment for AD-214 study to treat debilitating diseases
Clinical stage drug discovery company AdAlta (ASX: 1AD) has completed the recruitment of healthy volunteers to its Phase I extension study of lead candidate AD-214 to treat debilitating and fatal scarring diseases including idiopathic pulmonary fibrosis (IPF).
The study is designed to assess the safety and availability of multiple intravenous doses measuring 10 milligrams per kilogram, which is the highest dose anticipated to be used in future Phase II clinical studies.
AdAlta confirmed that eight participants had received between one and three doses of AD-214 or a placebo drug and four had received three doses.
No safety concerns have been reported by study investigators.
The company expects to have pharmacokinetic and receptor engagement results from the first three doses available in November to help advance partner and project financing discussions.
Full safety and tolerability results are due in the second quarter of next year.
AdAlta chief executive officer Dr Tim Oldham said the study was progressing well.
“We are grateful to all the volunteers who have participated and helped generate data which continues to show that AD-214 is well-tolerated… they are also helping to inform dosing regimens and the broader protocol for our Phase II study,” he said.
“In parallel with this, we have been progressing partner and financing discussions to help secure funds to progress AD-214 into further studies [and] potential partners have responded positively to the current study and recent results.”
AdAlta is using its proprietary i-body technology platform developed to solve challenging drug targeting problems and generate a new class of single-domain, antibody-enabled protein and cell therapeutics with the potential to treat challenging medical conditions.
The technology mimics the shape and stability of a versatile antigen-binding domain initially discovered in sharks and later developed as a human protein.
The result is a range of unique proteins capable of interacting with difficult-to-access targets using high selectivity, specificity and affinity.
They include G-protein coupled receptors (GPCRs) which have been implicated in many serious diseases.
AdAlta’s i-bodies are the first fully human single domain antibody scaffold and the first based on the shark motif to reach clinical trials.