AdAlta Ltd (ASX:1AD) has successfully dosed the first participants in its AD-214 Phase I extension study, marking the next milestone in the drug's development.
AD-214 is being developed to target fibrotic diseases, and the company’s continued progress in its clinical studies moves the field of fibrosis therapy towards delivering a solution to the market.
Interim results soon
The Phase 1 extension study, “Safety, Tolerability, PK and PD Study of AD-214 Administered to Healthy Volunteers and Patients with Interstitial Lung Disease or Chronic Kidney Disease”, aims to evaluate the safety and pharmacokinetic and pharmacodynamic profile of multiple doses of AD-214.
AdAlta is on track to achieve interim results from the study before the end of 2023, providing a glimpse into the drug's potential. The final assessment visits are expected to be completed, and full results are anticipated to be available in the first quarter of 2024.
These results will play a pivotal role in shaping the safety profile and target dosing schedule for AD-214's future Phase 2 studies, setting the stage for further advancements towards potential regulatory approvals and commercialisation.
Accelerated return to the clinic
The study uses higher doses than the previous Phase 1 study, effectively accelerating AD-214's return to the clinic by more than a year earlier than initially forecasted in 2022.
The study's primary goal is to gather essential data to inform and de-risk the design of the upcoming Phase 2 study.
“We extend our gratitude to the volunteers who are participating in this extension study,” AdAlta CEO and managing director Dr. Tim Oldham said.
“Their involvement is essential in advancing a potential new therapy for sufferers of debilitating and incurable idiopathic pulmonary fibrosis and other fibrotic diseases.
Partner interest
“The company’s meetings with potential partners continue to indicate that this study will materially enhance the attractiveness of AD--214 to partners.”
The Phase 1 extension study will initially enrol up to eight healthy volunteers, with six participants receiving AD-214 and two participants receiving a placebo.
The first group of two participants, termed the "sentinel group," has already received the first of four 10 mg/kg doses of AD-214 or placebo, and no issues have been reported so far.