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AdAlta (ASX:1AD) - CEO & Managing Director, Dr Tim Oldham
CEO & Managing Director, Dr Tim Oldham
Source: AdAlta
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  • AdAlta (1AD) has received Human Research Ethics Committee approval to commence a phase one clinical trial of its lead product candidate, AD-214
  • As a result of the green light, no further regulatory approval is required
  • The biotech company is utilising the i-body technology platform to develop a growing pipeline of i-bodies to initially treat fibrotic diseases
  • AD-214 is an Fc-Fusion protein that contains two AD-114 i-body molecules at the front end, and an Fc Fragment at the back end
  • When combined, the i-body and Fc Fragment supposedly create a superior next-generation lead drug candidate
  • The first healthy volunteer is expected to receive AD-214 in late July
  • Safety results from the phase one trial are expected early next year
  • AdAlta’s shares are up a healthy 29.6 per cent on the back of today’s news and are trading for 10.5 cents each

Biotech company AdAlta (1AD) has received Human Research Ethics Committee (HREC) approval to commence a phase one clinical trial of its lead product candidate, AD-214.

The approval comes after AdAlta has completed all the necessary pre-clinical safety and efficacy testing of AD-214 that’s required before human clinical trials can begin.

The phase one trial is being conducted under Australia’s Clinical Trials Notification (CTN) Scheme. This means the company won’t need further regulatory review and it can notify the Therapeutic Goods Administration (TGA) of the HREC approval to complete site initiation activities.

“This approval is a milestone that AdAlta has been working towards for many years,” Chief Scientific Officer Professor Michael Foley said.

AdAlta is utilising the power of the i-body technology platform to develop a growing pipeline of i-bodies to treat a range of conditions. The company is initially targeting fibrotic diseases.

AD-214 is an Fc-Fusion protein that contains two AD-114 i-body molecules at the front end, that bind to the human target, CXCR4. At the back end of AD-214 is the Fc Fragment or tail region of a traditional monoclonal antibody that will extend the duration of time in which the i-body will stay in the body.

When combined, the i-body and Fc Fragment create a superior next-generation lead drug candidate.

Healthy volunteer screening for Part A of the trial is expected to commence later this month and the first subject is expected to receive AD-214 in the second half of July.

Subject to the satisfactory completion of part A, the company will initiate parts B and C of the trial in patients with Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF), in early 2021.

“We are enormously proud to be able to say that AdAlta is now a clinical-stage company,” CEO and Managing Director Dr Tim Oldham said.

“This milestone is significant not only for AD-214 and all the patients for whom we are working to improve outcomes, but also because it demonstrates that AdAlta can use our i-body platform to develop therapeutic candidates against complex biological receptors from discovery through the complete preclinical development phase,” he added.

While the main endpoint of the trial is safety and tolerability of AD-214, AdAlta will investigate pharmacokinetic (the concentration of AD-214 in the blood over time) and pharmacodynamic (biological effects of AD-214 over time) parameters.

The trial isn’t designed to show evidence of efficacy against ILD or IPF, however, respiratory effects of AD-214 will be monitored for more information.

Safety results from the healthy volunteers are expected to be available at the beginning of next year.

AdAlta’s shares are up a healthy 29.6 per cent on the back of today’s news and are trading for 10.5 cents each at 1:08 pm AEST.

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