AdAlta Ltd (ASX:1AD) has wrapped up the enrolment of healthy volunteers for its AD-214 Phase 1 extension study, and early indications are that it is well tolerated.
The aim of the trial is to evaluate the safety of AD-214, the company’s flagship candidate for treating fibrotic diseases including Idiopathic Pulmonary Fibrosis.
Pivotal development
The Melbourne-based company, which focuses on novel protein and cell therapeutics, views this development as pivotal in progressing AD-214 to Phase 2 clinical trials.
Eight participants have successfully received at least their first dose of AD-214 or a placebo.
Four of them have also received the full three doses.
Study investigators have reported no safety concerns, bolstering the drug's profile for project financing and potential partnerships.
Pharmacokinetic and receptor engagement data are expected by November 2023, while complete safety and tolerability results are slated for release in the first quarter of 2024.
This accomplishment aids not just in the drug's future study phases, but also in its financial and partnership discussions.
Well tolerated
CEO and managing director Dr Tim Oldham said: “We are grateful to all the volunteers that have participated in this Phase 1 extension study.
“The data being generated continues to show that AD-214 is well tolerated and is also helping to inform dosing regimens and the broader protocol for our coming Phase 2 study for AD-214.
“It is additive to our recent laboratory studies which indicated that commercially suitable dosing frequencies could be clinically effective.
“In parallel with these workstreams, we have been progressing partnering and project financing discussions to help secure the funds to progress AD-214 into Phase 2 studies.
“Potential partners continue to respond positively to the current study and recent results.”