• AdAlta’s AD-214 Phase 1 extension study interim data reinforce safety profile and dose selection
  • Company preparing for partnering and Phase 2 trial of AD-214 into Idiopathic Pulmonary Fibrosis
  • In the US ~40,000 people die annually from Idiopathic Pulmonary Fibrosis, same mortality as breast cancer


Special Report: AdAlta’s planned Phase 2 trial of its lead asset AD-214 in Idiopathic Pulmonary Fibrosis (IPF) has been given a boost after its Phase 1 extension clinical study reinforced the safety profile and potential efficacy of the 10 mg/kg dose.

Clinical-stage biopharmaceutical development company AdAlta (ASX:1AD) says the favourable results of its phase 1 extension clinical trial are consistent with prior findings at lower doses, support ongoing partnering initiatives and further de-risk planned Phase 2 studies.

The Phase 1 extension clinical in healthy volunteers aimed to establish the safety of multiple 10 mg/kg doses of AD-214 and confirm this as the target dosing regimen for Phase II clinical efficacy studies.

1AD says all participants have now received three doses of AD-214, the same number as previously administered at 5 mg/kg doses, enabling interim comparison with these prior studies and dose simulation models.


Results consistent with findings at lower doses

1AD study investigators have reported no dose limiting toxicity, no need to interrupt doses and no requirement to administer medication to manage infusion reactions.

Furthermore, frequency of mild infusion related reactions appears lower than that observed at 5 mg/kg in the original Phase I study.

1AD says bioavailability of AD-214 and the blocking of its target receptor, CXCR4 was also in line with prior single dose studies, consistent across all three doses and, most significantly, in line with the predictions of dose simulation models.

The immune response to AD-214, as measured by the number of participants in which anti-drug antibodies were detected and the level of these antidrug antibodies, was lower at this time point than observed in prior multi-dose studies.


Developing next gen protein therapeutics

1AD is using its i-body® platform to discover and develop next generation protein therapeutics addressing drug targets that are challenging for other technologies.

The biotech says an i-body® is a unique human protein that combines the advantages of small molecules for stability and antibodies, with a high affinity and specificity for treating certain illnesses, in one powerful treatment.

1AD’s internal pipeline is focused on G protein-coupled receptors GPCRs implicated in fibrotic and inflammatory disease and cancer.

The biotech’s external pipeline is leveraging partner expertise to pursue a wider range of targets and indications.

1AD says AD-214 is a first in class molecule being being developed for the treatment of IPF and other fibrotic diseases, for which current therapies are sub-optimal.


More effective treatments needed for deadly disease

1AD says in the US ~21,000 people die each year from IPF, which is more than half the mortality of breast cancer.

IPF affects the lung’s alveolar or air sac tissue, causing it to thicken and stiffen.

The thickening leads to permanent scarring (fibrosis) in the lungs, gradually impeding normal breathing functions.

Factors such as smoking or a family history of IPF heighten the risk of developing IPF, which also escalates with age.

It is more common in men than women, and mostly affects people over 50 years of age.

Primary symptoms include breathlessness and coughing, although some individuals might not initially exhibit any signs. Symptoms can get worse as the disease progresses.

While considered a rare disease the American Lung Association says it is more common than once thought, with up to 207,000 people affected in the US and about 58,000 new cases diagnosed each year.

In 2017, 1AD was given orphan drug designation with the US FDA. The designation means it gets increased access to the FDA, new drug application fee waivers, a potentially faster route to market plus an additional seven years of exclusivity once the drug is on market.


Results de-risking Phase 2 trial and enhance partnership discussions

CEO and managing director Tim Oldham says the interim results were very much in-line
with the company’s expectations.

“We have therefore materially reduced Phase 2 clinical trial risk by reinforcing the
favourable safety profile for AD-214 at planned Phase II doses, and matching the predictions of our dose simulation model that led us to believe this 10 mg/kg dose every two weeks could be effective,” he says.

“We are sharing these results with potential partners and anticipate that they will further enhance our existing out-licensing and project financing discussions.”

He says the study participants will receive a fourth and final dose twelve weeks after their third dose with the aim of confirming that there is no immune response to AD-214 that might affect efficacy and safety.

Full safety and tolerability results are due in the March Quarter of 2024.

To support its clinical program 1AD recently announced it had commitments to raise $1.65 million in an oversubscribed placement to institutional and sophisticated investors.

As a result of oversubscriptions 1AD says $450k worth of subscriptions will be subject to shareholder approval at an EGM in December.



This article was developed in collaboration with AdAlta, a Stockhead advertiser at the time of publishing.


This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.