Hoth Therapeutics Reports 100% Success Rate in Phase 2a Trial for HT-001 to Combat Cancer Treatment Side Effects

Hoth Therapeutics Achieves Breakthrough in Phase 2a Trial: HT-001 Delivers 100% Success in Combating Cancer Treatment Skin Toxicities

Highlights

• 100% of Patients in Cohort 1 Achieve Primary Efficacy Endpoint: The results from the open-label portion of the CLEER-001 trial demonstrate remarkable success, with all patients achieving the primary efficacy endpoint of an ARIGA score ≤1 by the six-week mark.
• No Treatment-Related Adverse Effects Observed: Crucially, no treatment-related adverse effects have been reported, reaffirming HT-001’s excellent tolerability and safety profile.
• Preserves Cancer Treatment Efficacy with Zero Dose Reductions: Notably, all patients maintained their full EGFRi dosage, preserving the cancer treatment’s full therapeutic effect—a significant improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects.

Exceptional Patient Outcomes

Data from the open-label portion of the CLEER-001 trial demonstrated remarkable success:

• 100% of patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.
• 66% of patients reported reduced pain and itching scores, further enhancing quality of life.

A Groundbreaking Approach

The trial uses the proprietary Acneiform Rash Investigator Global Assessment Scale (ARIGA), developed in collaboration with onco-dermatology experts. The innovative scale ensures precise measurement and assessment of skin toxicity improvements.

Robb Knie, CEO of Hoth Therapeutics, commented, "These results are a significant milestone, underscoring HT-001’s potential to transform patient care by mitigating debilitating skin toxicities while maintaining critical cancer treatments."

A Strong Safety Profile

No treatment-related adverse effects have been reported, reaffirming HT-001’s excellent tolerability and safety profile.

Looking Ahead, Knie added, "As the study progresses, we anticipate further validating these results and are excited about the potential impact HT-001 could have on patient outcomes."

About Hoth Therapeutics, Inc.

Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and groundbreaking treatments with a goal to improve patient quality of life. The company is committed to advancing therapies like HT-001 that hold immense potential to create breakthroughs and diversify treatment options.

Forward-Looking Statement

This press release includes forward-looking statements based upon Hoth’s current expectations. These statements concern the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of marketing approvals; the potential market size and opportunity for our products and product candidates; the potential benefits of our products and product candidates; the potential risks and uncertainties that could cause actual results to differ materially from those indicated by these forward-looking statements as a result of various important factors, including but not limited to, market conditions and the factors described in the section titled "Risk Factors" in Hoth’s most recent Annual Report on Form 10-K and Hoth’s other filings made with the U. S. Securities and Exchange Commission.

Investor Contact

For more information about Hoth Therapeutics or its products and product candidates, please contact:

LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
Phone: (678) 570-6791