AdAlta Ltd (ASX:1AD) has reported positive outcomes from its AD-214 Phase 1 extension study.
This study aims to assess the safety and availability of multiple 10 milligrams per kilogram intravenous doses of AD-214, the company's lead drug candidate.
AD-214 holds promise as a first-in-class therapy for debilitating fibrotic diseases, including Idiopathic Pulmonary Fibrosis (IPF), and this Phase 1 extension study reinforces its potential as a treatment option in this critical medical area.
Successful dosing
All eight healthy volunteers participating in the study have successfully received three doses of AD-214.
Investigators continue to report no safety concerns, confirming the favourable tolerability profile observed at lower doses of AD-214.
The study revealed a lower frequency of mild infusion-related reactions compared to lower doses in the original Phase 1 study. This bodes well for the drug's safety and tolerability profile.
Outcomes support partnering and financing
The Phase 1 extension study's outcomes support AdAlta's partnering program for AD-214.
The company has made substantial progress in discussions related to partnering and project financing, and aims to advance AD-214 into Phase 2 studies.
CEO and managing director Dr Tim Oldham said: “We continue to be grateful to the volunteers participating in this Phase 1 extension study.
“The favourable safety profile of AD-214 continues to be demonstrated at the anticipated Phase 2 clinical study doses.
“This study also supports our partnering program for AD-214 and we are pleased to have materially progressed several partnering and project financing discussions over the past month to help progress AD-214 into Phase 2 studies.”
What’s next?
Looking ahead, full pharmacokinetic and receptor engagement analysis will commence as scheduled, with discussions with potential partners set for November 2023.
In twelve weeks, participants will receive a final dose to confirm the absence of any immune response that might affect efficacy and safety.
Comprehensive safety and tolerability results are expected in the March quarter of 2024.