AdAlta (ASX:1AD) has announced results from its Phase 1 extension study of lead asset AD-214 in development for fibrotic diseases, including the debilitating and fatal disease, Idiopathic Pulmonary Fibrosis (IPF).
The company said the trial established the safety and tolerability of the planned Phase II dose.
AdAlta CEO and managing director Tim Oldham said, “With these excellent results, we believe we have answered in the best way possible the key clinical questions large pharma company partners have been asking about AD-214. With these questions answered, the molecule is now prepared for Phase II clinical studies, a significant milestone for AdAlta.
“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.”
The company said the study was designed to assess the safety and tolerability of planned Phase 2 doses of AD-214 and answer questions from potential partners. All participants received four doses of AD-214. The first three were two weeks apart, as planned for the Phase 2 study. The fourth dose was 12 weeks after the third and designed to assess the effect, if any, of anti-drug antibodies (ADAs) raised by the body against AD-214.
The company said AD-214 was well tolerated at 10 mg/kg intravenously (IV) every two weeks. The bioavailability and pharmacokinetics of AD-214 was consistent across all doses and with prior single dose studies. ADAs were detected at low levels in all participants in the study but did not affect AD-214 PK or PD, said the company.
