La Trobe University's Research and Innovation Precinct Partner AdAlta Limited announced it has received Human Research Ethics Committee approval to commence a Phase I clinical trial of its lead product candidate, AD-214.
AdAlta Limited, a clinical stage drug development company, is using its proprietary i-body technology platform to solve challenging drug targeting problems and generate a promising new class of single domain antibody protein therapeutics with the potential to treat some of today’s most challenging medical conditions. AD-214 is being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other human fibrotic diseases, for which current therapies are sub-optimal and there is a high unmet medical need.
AdAlta Chief Scientific Officer, Prof Michael Foley commented, “This approval is a milestone that AdAlta has been working towards for many years. It is based on the first independent review of our complete pre-clinical development package and confirms that AdAlta has completed all the necessary safety and efficacy testing to support progressing the development of AD-214 into human clinical studies. We are incredibly grateful to the healthy volunteers, patients and physicians who will participate in this study to help improve outcomes for those suffering the debilitating effects of Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF).”
CEO and Managing Director Dr Tim Oldham added, “We are enormously proud to be able to say that AdAlta is now a clinical stage company. 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.”
AdAlta also advises that the development of a radio-labelled version of AD-214 for PET imaging has recommenced following staged return to work at a collaborator laboratory. The radio-labelled version remains on track for introduction into the patient cohorts of the Phase I program in the first quarter of 2021 where it will add significant clinical and partnering value to the Phase I program.
Additional details about the trial design can be found at ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world.
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