Phase I extension study of AD-214 tested the target Phase II dose of AD-214 in healthy volunteers
AdAlta says the findings positively answer key partner questions and support progressing AD-214 Phase II clinical studies in Idiopathic Pulmonary Fibrosis (IPF)
Results now being shared with existing pipeline of potential partners
Special Report: Key results from a Phase I extension study of AdAlta’s lead asset, AD-214, have positively answered questions being asked by pharma partners, while establishing the tolerability of the planned Phase II dose.
AdAlta’s (ASX:1AD) lead asset, AD-214, is being developed for fibrotic diseases, including the debilitating and fatal disease, Idiopathic Pulmonary Fibrosis (IPF).
The company recently undertook a Phase I extension study of AD-214 to evaluate the safety and tolerability of multiple intravenous (IV) 10 mg/kg doses in healthy volunteers.
Collecting the data was essential for both progressing to Phase II studies and for partnering. All participants received four doses of AD-214, with the fourth dose 12 weeks after the third and designed to assess the effect of antidrug antibodies (ADAs), a common response to biologic drugs.
Top line results
Key findings of the study demonstrated that AD-214 was well tolerated at 10mg/kg intravenously (IV) every two weeks, while the bioavailability was consistent across all doses.
The pharmacodynamic (PD) activity of AD-214 as measured by transient changes in white blood cell counts was consistent across all doses and with prior single dose studies. Blocking of AD-214’s target receptor was also in line with expectations and supported potential efficacy of this dose.
Antidrug antibodies (ADAs) were detected at low levels in all participants in the study but did not affect AD-214 PK or PD, supporting 1AD’s hypothesis that the low levels of ADAs are unlikely to be of clinical safety or efficacy concern.
Prepped for Phase II studies
Understanding the ADA profile of AD-214 is a key priority for potential pharmaceutical company partners and with these questions now answered, 1AD believes the molecule is prepped for Phase II clinical studies.
“This is a significant milestone for AdAlta,” 1AD managing director and CEO Tim Oldham says.
“We have already commenced the process of sharing these latest results with our potential partners with a view to progressing a licensing or asset financing transaction in the near term.
“Such a transaction would enable AD-214 to advance to Phase II clinical trials in Idiopathic Pulmonary Fibrosis to provide a new option for patients with this debilitating and fatal disease as well as providing a return on our investment to date.”
Results now being shared with existing pipeline of potential partners with a view to progressing a licensing or asset financing transaction in the near term.
This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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