Clinical stage biotechnology company AdAlta Limited (ASX:1AD) has received promising notifications from the United States (US) Food and Drug Administration (FDA) on the development of its AD-214 drug.
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 said the advice from e USFDA indicates that:
Specific FDA guidance has been incorporated into the protocol for the current Phase I trial.
CEO and Managing Director, Dr Tim Oldham, said the FDA guidance was provided in response to AdAlta’s request for a Pre-Investigational New Drug Application (Pre-IND) meeting. IND applications are made when seeking to commence clinical development of therapeutic products in the US. Pre-IND meetings can be requested prior to IND submission to discuss the proposed product and clinical development program and receive guidance from the FDA to ensure completeness of the IND application and maximise probability of IND approval.
Dr Oldham said AdAlta does not require FDA approval of an IND application in order to conduct its current Phase I programme in Australia, however seeking advice now ensures that FDA specific requirements can be incorporated into current clinical and ongoing pre-clinical development.
This is the second independent review of the AD-214 preclinical data,” Dr Oldham said.
“It provides AdAlta and our potential partners increased confidence that AD-214’s development plan can obtain support from the FDA for future US clinical trials and is of international regulatory standard.
“It has been a straightforward process to incorporate the guidance received into our pre-clinical and Australian Phase I trial programme.”
The FDA also agreed that AdAlta’s Phase I clinical trial design, encompassing both healthy volunteers and Interstitial Lung Disease (ILD)/Idiopathic Pulmonary Fibrosis (IPF) patients, is “reasonable”.
FDA review of the preclinical data concluded that AD-214 may show biological activity at doses lower than AdAlta’s originally proposed starting dose of 1 mg/kg. To ensure that a complete clinical profile of AD-214 biological activity is available for future FDA review, AdAlta has amended Part A of its Australian Phase I protocol in healthy volunteers.
Part A of the Phase I trial remains on track for completion by the end of 2020 with top line safety data due at the beginning of 2021. Part A of the Phase I clinical study remains fully funded. FDA comments regarding Parts B and C of the Phase I trial in ILD/IPF patients will be incorporated, if warranted, during the planned review of Part A results with the HREC.
AdAlta plans to include the results of the Phase I trial alongside the full pre-clinical data set in an IND application to the FDA which will be required if trials are to be completed in the US by AdAlta or a potential partn