lncTAC today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for LT-010, a first-in-class (FIC) small nucleic acid therapy developed from the company's proprietary transdermal delivery platform. This milestone accelerates lncTAC's global strategic expansion.  

Preclinical data and results from investigator-initiated trials (IITs) demonstrated:

· Superior efficacy: In key endpoints such as hair density, LT-010 significantly outperformed currently marketed representative treatments.

· Better safety: No drug-related adverse events were reported in large animal models or in IIT subjects who received once-weekly topical applications for 52 consecutive weeks.

· Improved patient compliance: The once-weekly dosing regimen required to maintain efficacy substantially enhances patient adherence.

Earlier, the core technology behind this program was presented as an oral report at the 83rd Annual Meeting of the Society for Investigative Dermatology (SID), where it received high praise from international experts.

This FDA IND clearance marks a major milestone for lncTAC. Moving forward, the company will continue to advance its four delivery platforms and corresponding pipelines covering dermatology, oncology, central nervous system (CNS), and respiratory diseases, accelerating clinical translation of its lncRNA and extrahepatic nucleic acid delivery platforms to bring breakthrough therapies to patients.