Shanghai Leadingtac Pharmaceutical Co., Ltd. (hereinafter referred to as "Leadingtac"),  a clinical-stage biopharmaceutical company focused on the development of protein degrader for the treatment of chronic inflammatory and autoimmune diseases,  announced on June 25th that the first healthy volunteer has been dosed in Phase 1 trial evaluating the safety,  pharmacokinetic profile and food effects of LT-002. 

LT-002 is a highly potent protein degrader targeted for IRAK4, being developed for autoimmune disease including Hidradenitis Suppurativa and Atopic Dermatitis, where IRAK4 play an important role in pathogenesis. LT-002 is a first in class IRAK4-targeted protein degrader in China and second in class following Kymera's KT-474. The molecule was screened on in house Targeted Protein Degradation (TPD) platform Nano-SPUD®, demonstrating superior efficacy in improving the symptoms of skin inflammation in preclinical animal model, as well as a favorable safety profile.

The Phase 1 double-blind, placebo-controlled, first-in-human study is designed to assess the safety, tolerability and pharmacokinetics of a single ascending dose and multiple ascending doses of orally administered LT-002 tablets. The dosing of the first healthy volunteer represents an important inflection point for Leadingtac, which is meaningful in the development of this important pipeline.  

“This is a very exciting step in the development of LT-002” said Dr. Yan Feng, Leadintac’s Founder and CEO. “From the inception of this project to the present, we have overcome numerous difficulties and tremendous challenges.  However, we are very fortunate to have a strong team and firm support from our investors and our partners. The dosing of our first HV is a hallmark of our journey towards developing novel therapeutic solutions to patients around the world and we are very much looking forward to seeing the positive results of the Phase I clinical trial that will have the potential to treat autoimmune diseases.” 

About Leadingtac:

Leadingtac is a clinical-stage biopharmaceutical company based in Zhangjiang, Shanghai. The company is founded in 2019, dedicated to First-in-class/Best-in-class small molecule innovative drug discovery and development, focusing on autoimmune and oncology, two disease areas with many unmet clinical needs, with Targeted Protein Degradation (TPD) drug discovery and development technology at its core business.  Leadingtac currently has a laboratory and office area of about 2,000 square meters, with 20 formal employees and has completed three rounds of funding since its establishment.