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New data from AdAlta Limited supports the efficaciousness of AD-214 in treating Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases. The data revealed that meaningful inhibition can be achieved at much lower levels which may allow for a clinically convenient dosing frequency of every two weeks.
Such findings have de-risked and improved confidence in the dosing regimens for AD-214 Phase II clinical studies. This is instrumental in addressing a key question from potential commercial partners about linking a clinically measurable parameter (receptor occupancy) with efficacy.
The disclosed data favourably connects the results from preclinical animal studies and Phase I clinical trials of AD-214. This is significant as it provides insights into the effective dosing frequency for the Phase II study of AD-214.
AdAlta Limited has secured Human Research Ethics Committee (HREC) approval to commence a Phase I extension clinical study of its main product candidate, AD-214, set to start with the first healthy volunteer in August 2023.
The AD-214 Phase I extension study is designed to confirm safety and pharmacokinetic and pharmacodynamic trends of multiple doses of AD -214 using higher doses than in the previous study, contributing significantly to ongoing partnering discussions as well as reducing Phase II study time and cost.
Apart from a healthy volunteer cohort, the HREC approval also includes a patient cohort which could confirm the safety of AD-214 when administered in combination with standard of care, catering to patients suffering from idiopathic pulmonary fibrosis and other fibrotic diseases.
AdAlta Limited has been granted a second Japanese patent relating to its lead program, AD-214.
The patent is directed to polypeptides containing the binding loops of the company’s lead i-body AD-214.
The patent coverage extends to i-bodies that are related to AD-214 for treating CXCR4-related diseases or disorders which includes the lead indication of idiopathic pulmonary fibrosis as well as cancer, viral infections, inflammatory diseases, sclerosis, kidney disease, eye disorders and immune deficiency disorder s and wounds