AutotechBio's Dementia New Drug 'ATB2005' Receives Approval for Phase 1 Clinical Trial Plan
Autotech Bio announced on the 5th that it recently received approval from the Ministry of Food and Drug Safety for the clinical phase 1 trial plan (IND) of 'ATB2005,' a candidate drug for degenerative neurological diseases developed with the support of the Dementia Overcoming Research and Development Project Group.
ATB2005 is a new drug candidate based on a targeted protein degradation (TPD) platform developed by Professor Yongtae Kwon of Seoul National University College of Medicine as a targeted degrader of the pathological Tau protein, known as a cause of Alzheimer's dementia. Autotech Bio, founded by Professor Kwon, secured non-clinical data through a three-year research project under the Dementia Overcoming Research and Development Project, enabling progression to human clinical trials.
Previous non-clinical studies confirmed that ATB2005 exhibits efficacy in improving various degenerative neurological diseases caused by pathological Tau protein.
This clinical trial, led by Professor Kyungsang Yoo's team from the Department of Clinical Pharmacology at Seoul National University Hospital, is a randomized, double-blind, placebo-controlled, dose-escalation phase 1 study that will orally administer ATB2005 to healthy adult males to evaluate safety, tolerability, and pharmacokinetic properties. Full-scale dosing is expected to commence in the first half of next year.
CEO Yongtae Kwon stated, “ATB2005 secured a wide safety margin with excellent efficacy and safety in non-clinical studies,” adding, “With this IND approval, we are accelerating our entry into the global Alzheimer's market, where unmet needs are high.”
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Inhee Muk, director of the Dementia Overcoming Research and Development Project Group, also congratulated, saying, “We celebrate Autotech Bio’s advancement to the clinical phase and IND approval for phase 1 trials through specific technology development based on autophagy mechanisms grounded in basic research.” She added, “The project group will continue to actively discover and support the development of internationally competitive dementia causative treatments.”
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