Leadingtac announced on March 18, 2025 that the Phase I human clinical trial of LT-002 (IRAK4 protein degrader), a small molecule drug candidate for the treatment of hidradenitis suppurativa, atopic dermatitis and other dermatological disorders, has been successfully completed in all healthy volunteers. volunteers and the last subject will be discharged on March 31st.

Following Leadingtac's initiation of the first healthy volunteer dosing of its IRAK4-targeted drug LT-002 on June 25, 2024, the company has successfully completed the safe dosing of all of its more than 100 healthy volunteers in a short span of nine months. This is an important milestone reached in the clinical development process of the LT-002 program, marking the entry of the program into Phase IC/II clinical trials to explore the safety and efficacy of LT-002 in patients with hidradenitis suppurativa and atopic dermatitis, among others.

The Phase I clinical trial of LT-002 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetic profile of LT-002 in healthy adults through single ascending dose (SAD) and multiple ascending dose (MAD) administration.The study explored single administration of 9 doses and multiple administration of 4 doses and the results demonstrated a favorable safety and pharmacokinetic profile. According to the current unblinded data, LT-002 showed good safety and tolerability in all healthy volunteers; meanwhile, the drug showed high accumulation in the skin of target tissues, and significant degradation of IRAK4 protein in both peripheral blood mononuclear cells (PBMC) and skin, which was able to reach more than 99% and 90%, respectively, and showed significant dose-dependence; In addition, LT-002 significantly inhibited the release of several pro-inflammatory cytokines, demonstrating its great potential in anti-inflammation.

Dr. Yan Feng, Founder and CEO of Leadingtac, said, “We are very pleased to see the outstanding performance of LT-002 in the Phase I clinical trial, which not only validates the certainty of our research and development direction, but also strengthens our confidence in continuing to push forward with subsequent clinical studies.” He further noted that the success of this trial provides new hope and options for future therapies targeting autoimmune diseases such as hidradenitis suppurativa and atopic dermatitis.

About Us:

Leadingtac is a leading company in the field of PROTAC drug discovery and development in China. Founded at the end of 2019, Leadingtac has established R&D centers in Zhangjiang, Pudong, Shanghai and Keqiao, Shaoxing, Zhejiang. The company's R&D direction focuses on Target Protein Degradation, and has independently developed SPUD® (Specific Protein Ubiquitination and Degradation), which can efficiently and rapidly screen for proteasomal degradation, new E3 ligand screening, and lysosomal degradation. Ubiquitination and Degradation) technology platform:

Nano-SPUD® for Target Proteins

Nano-SPUD® for E3 Ligases

Lyso-SPUD® for Lysosome

Based on this platform, Leadingtac has independently developed its first pipeline of IRAK4 degraders, LT-002, for the treatment of autoimmune diseases, which has a huge market potential and has been approved by the CDE and FDA to enter clinical trials in China and the United States, and is the first in the country and the second in the world in terms of research and development progress.

Leadingtac's follow-on pipeline includes the JAK-STAT pathway, KRAS and other difficult-to-adhere-to targets for the treatment of autoimmune diseases, as well as solid tumors such as lung, pancreatic, and colorectal cancers, all of which are also leading the world in terms of R&D progress.