AdAlta Limited (ASX: $1AD) Phase I extension study achieves critical milestone for Phase II and partnering

AdAlta Limited (ASX: $1AD) has announced the successful completion of the Phase I extension study of its lead asset AD-214, achieving a critical milestone for Phase II clinical studies in Idiopathic Pulmonary Fibrosis (IPF). The study confirmed the safety, tolerability, and bioavailability of the target Phase II dose, addressing key partnering questions and supporting the progression of AD-214 to Phase II clinical studies.

Executive Commentary

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.

Summary

AdAlta's Phase I extension study of AD-214 has successfully established the safety, tolerability, and bioavailability of the target Phase II dose, supporting its progression to Phase II clinical studies in Idiopathic Pulmonary Fibrosis (IPF). The study results have positively addressed key partnering questions, positioning AD-214 for potential licensing or asset financing transactions in the near term. The company aims to provide a new treatment option for patients with IPF while generating a return on its investment. AdAlta is pursuing out-licensing to large biopharmaceutical companies or co-developing AD-214 in an asset-specific investment vehicle. The completion of the Phase I extension study marks a significant milestone for AdAlta's corporate strategy and its commitment to addressing unmet medical needs in fibrotic diseases.