Hoth Therapeutics Achieves Groundbreaking Results in Phase 2a Clinical Trial with 100% Success Rate for HT-001 in Reducing Cancer Treatment-Related Skin Toxicities

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100% of Patients in Cohort 1 Achieve Primary Efficacy Endpoint

  • The Phase 2a clinical trial of HT-001 demonstrated remarkable success in addressing skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients.
  • All patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.

No Treatment-Related Adverse Effects Observed

  • The innovative therapy, HT-001, has shown a strong safety profile with no treatment-related adverse effects reported.
  • This is a crucial finding, as it underscores the potential of HT-001 to mitigate debilitating skin toxicities while maintaining critical cancer treatments.

Preserves Cancer Treatment Efficacy with Zero Dose Reductions

  • A significant improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects.
  • The data highlight HT-001’s potential to set a new standard of care in this underserved area.

Exceptional Patient Outcomes

Data from the Open-Label Portion of the CLEER-001 Trial

  • 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.

Remarkable Success: 100% of Patients Achieve Primary Efficacy Endpoint

  • All patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.
  • This is a groundbreaking approach to addressing skin toxicities linked to EGFRi in cancer patients.

Reduced Pain and Itching Scores

  • 66% of patients reported reduced pain and itching scores, further enhancing quality of life.
  • This is a crucial finding, as it underscores the potential of HT-001 to mitigate debilitating skin toxicities while maintaining critical cancer treatments.

Preserving Cancer Treatment Efficacy

  • Crucially, all patients maintained their full EGFRi dosage, preserving the cancer treatment’s full therapeutic effect.
  • This is a significant improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects.

A Groundbreaking Approach

The Innovative Scale: ARIGA

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

CEO’s Remarks

  • "These results are a significant milestone, underscoring HT-001’s potential to transform patient care by addressing the debilitating side effects of cancer treatment."
  • "We believe that this breakthrough has the potential to change the standard of care for patients receiving EGFRi therapy."

A Strong Safety Profile

No Treatment-Related Adverse Effects Reported

  • The innovative therapy, HT-001, has shown a strong safety profile with no treatment-related adverse effects reported.
  • This is a crucial finding, as it underscores the potential of HT-001 to mitigate debilitating skin toxicities while maintaining critical cancer treatments.

Preserving Cancer Treatment Efficacy

Zero Dose Reductions or Treatment Halts

  • A significant improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects.
  • The data highlight HT-001’s potential to set a new standard of care in this underserved area.

Conclusion

  • The Phase 2a clinical trial of HT-001 has demonstrated remarkable success in addressing skin toxicities linked to EGFRi in cancer patients.
  • With its strong safety profile and ability to preserve cancer treatment efficacy, HT-001 has the potential to set a new standard of care for this underserved population.

Investor Contact

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

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