Clinical stage medicine developer AdAlta (ASX:1AD) has completed the enrolment of healthy volunteers into its AD-214 phase one extension study.
The $9.71 million market capitalisation company says all 8 participants have now received at least their first dose of the medicine candidate being developed as a first-in-class therapy to treat debilitating and fatal fibrotic diseases.
These diseases include idiopathic pulmonary fibrosis (IPF).
AdAlta reports the phase one extension study is designed to assess the safety and availability of multiple 10 milligram per kilogram (mg/kg) intravenous doses of AD-214, which is the highest dose anticipated to be used in the forthcoming phase two clinical studies.
Of the 8 participants, 4 have received 3 doses of AD-214, while the remaining candidates have received at least one dose or a placebo. To date, no safety concerns have been reported by study investigators.
AdAlta anticipates having pharmacokinetic and receptor engagement results from the first 3 doses available for discussion with partners in November this year, with full safety and tolerability results due in March 2024.
Speaking on the completion of enrolment, AdAlta Chief Executive Officer (CEO) and Managing Director Dr Tim Oldham says: “We are grateful to all the volunteers that have participated in this Phase One 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 Two study for AD214.
It is additive to our recent laboratory studies which indicated that commercially suitable dosing frequencies could be clinically effective.
“The data being generated continues to show that AD-214 is well tolerated”
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 Two studies. Potential partners continue to respond positively to the current study and recent results.”
AdAlta is an ASX-listed developer headquartered in Melbourne, Australia, that uses its proprietary i-body technology platform to solve challenging medication targeting problems as well as generate a ‘promising’ new class of single domain antibody-enabled protein and cell therapeutics.
The company’s leading candidate, AD-214, is being developed for the treatment of IPF and other human fibrotic diseases for which current therapies are sub-optimal and there is a high unmet medical need.
Write to Adam Drought at Mining.com.au