On December 3, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused clinical-stage biopharmaceutical company, reported a comprehensive update on its therapeutic pipeline. The Company detailed meaningful progress across HT-001, HT-KIT, HT-ALZ, and its newly launched GDNF-based metabolic program, while continuing to strengthen its global intellectual-property portfolio and expand strategic research partnerships.
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Pipeline Highlights
HT-001 (Topical Epidermal Growth Factor Inhibitor) – Phase 2 CLEER-001 Trial Advancing
Hoth continues to advance HT-001 in its Phase 2 CLEER-001 clinical trial targeting EGFR-inhibitor–associated rash, a significant unmet need in oncology supportive care.
Recent progress includes:
Strong safety profile to date with no dose-limiting toxicities observed.
Consistent improvement trends in rash severity and pruritus
Increased clinical-site engagement and favorable investigator feedback.
A further clinical update is anticipated in the coming months as enrollment continues to progress.
HT-KIT (Orphan Drug Designation for Mast Cell Diseases) – IND Preparation Underway
HT-KIT, Hoth’s targeted KIT-inhibitor program for mastocytosis and related mast-cell–driven diseases, continues to progress through IND-enabling activities.
Key accomplishments:
FDA Orphan Drug Designation already granted.
Compelling preclinical efficacy showing potent KIT inhibition and suppressed mast-cell activation.
IND-enabling toxicology studies moving toward completion.
Ongoing manufacturing scale-up and analytical characterization
Hoth expects to finalize its’ IND submission in 2026, followed by first-in-human studies.
HT-ALZ (Therapeutic for Alzheimer’s Disease) – Advancing Through GLP and PK Development.
HT-ALZ continues to deliver supportive data across absorption, distribution, and neuroinflammatory pathways.
Recent highlights:
GLP studies underway with positive PK, biodistribution, and CNS-penetration modeling
Regulatory-facing package expected to mature in 2026.
GDNF-Based Weight-Loss & Metabolic Program (VA Collaboration) – Newly Accelerated Initiative
Hoth’s newest program leverages GDNF (Glial-Derived Neurotrophic Factor) to target obesity, hepatic steatosis, and metabolic dysfunction, representing one of the largest and fastest-growing therapeutic markets globally.
Recent achievements:
Study preparations initiated with the Atlanta VA Medical Center
Mouse procurement completed; high-fat-diet regimen launches per approved VA protocols.
Aim 1 of the research program now underway, with early data expected in 2026.
Program supported by strong academic collaboration and growing IP protection.
Expanding Intellectual Property & Strategic Collaborations
Hoth continues to broaden its IP position through new filings and expanded protection around:
HT-001 dermatology and oncology-supportive-care mechanisms
HT-KIT mast-cell-disease formulations, methods, and manufacturing
HT-ALZ CNS-focused data and delivery systems
GDNF weight-loss and hepatic-function applications
The Company maintains collaborations with leading institutions, including the Atlanta VA Medical Center, academic neuroscience groups, and AI-assisted discovery platforms.
Upcoming Milestones
CLEER-001 Phase 2 HT-001 clinical data update
Completion of toxicology and IND filing for HT-KIT
GLP, BBB, and PK updates for HT-ALZ
VA metabolic program early findings
Management Commentary
Robb Knie, Chief Executive Officer of Hoth Therapeutics, commented:
"Our therapeutic pipeline has never been more focused or better positioned. With HT-001 advancing in the clinic, HT-KIT nearing IND submission, HT-ALZ progressing through GLP development, and our new GDNF program targeting one of the largest markets in medicine."
(Press release, Hoth Therapeutics, DEC 3, 2025, View Source [SID1234661114])