Innovative biotech company AdAlta (ASX: 1AD) has been approved to commence human clinical trials for its next generation of protein therapeutics aimed at solving drug targeting problems commonly encountered in the sector. 

Approval has been granted by the Human Research Ethics Committee which enables AdAlta to commence recruiting healthy participants for trials of AD-214, their lead i-body candidate for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Current IPF therapies are sub-optimal for the 300,000 sufferers of the incurable disease which leads to more than 40,000 deaths annually at a median time of death 3.8 years after diagnosis. 

 “We are enormously proud to be able to say that AdAlta is now a clinical stage company,” said AdAlta Managing Director, Dr Tim Oldham. 

“This milestone is significant not only for AD-214 and all the patients for whom we are working to improve outcomes, but also because it demonstrates that AdAlta can use our i-body platform to develop therapeutic candidates against complex biological receptors from discovery through the complete preclinical development phase.”

Key to AdAlta’s technology is its proprietary i-body technology which mimics the shape and stability of a unique and versatile antigen-binding domain. Initially discovered in sharks, it was then developed as a human protein. 

On further research and development, it created a range of proteins capable of interacting with high selectivity and affinity towards previously difficult to access targets such as G-protein coupled receptors that are present in many serious diseases.

Phase I trials of AD-214 will initially focus on top line safety and tolerability with AdAlta hoping to advance towards trials on IPF patients in early-2021.  

Highlighting interest in AdAlta’s i-body technology, the company was engaged by GE Healthcare for a collaborative partnership which commenced in September 2019.

Following news of their approval to commence clinical trials, 1AD shares responded strongly to reach a high of $0.105 in morning trade, a 29.6% rise on the previous $0.081 close.