Hoth Therapeutics(US:HOTH) Prnewswire·2025-12-03 19:00Core Insights - Hoth Therapeutics, Inc. has provided a comprehensive update on its therapeutic pipeline, highlighting significant progress in multiple programs including HT-001, HT-KIT, HT-ALZ, and a new GDNF-based metabolic initiative [1] Pipeline Highlights - HT-001 (Topical Epidermal Growth Factor Inhibitor): The Phase 2 CLEER-001 trial is advancing with a strong safety profile, no dose-limiting toxicities, and consistent improvement in rash severity and pruritus. Further updates are expected as enrollment continues [1] - HT-KIT (Orphan Drug Designation for Mast Cell Diseases): The program is progressing through IND-enabling activities, having received FDA Orphan Drug Designation. Preclinical efficacy shows potent KIT inhibition, and IND submission is expected in 2026 [1] - HT-ALZ (Therapeutic for Alzheimer's Disease): The program is advancing through GLP and PK development, with positive data on absorption, distribution, and CNS penetration. A regulatory package is expected to mature in 2026 [1] - GDNF-Based Weight-Loss & Metabolic Program: This new initiative targets obesity and metabolic dysfunction, with study preparations initiated at the Atlanta VA Medical Center. Early data is expected in 2026 [1] Intellectual Property & Collaborations - Hoth is expanding its intellectual property portfolio through new filings related to HT-001, HT-KIT, HT-ALZ, and GDNF applications. The company maintains collaborations with leading institutions and academic groups [1] Upcoming Milestones - Key upcoming milestones include updates on the CLEER-001 Phase 2 clinical data, completion of toxicology and IND filing for HT-KIT, GLP and PK updates for HT-ALZ, and early findings from the VA metabolic program [1] Management Commentary - The CEO of Hoth Therapeutics emphasized that the therapeutic pipeline is well-positioned, with advancements across multiple programs targeting significant medical needs [1]