HT-001 Improves Skin Side Effects From EGFR Treatments

Hoth Therapeutics reported new data on March 24, 2026, in New York showing that the topical treatment HT-001 demonstrated encouraging pharmacokinetics (PK), safety and clinical activity in patients with cancer experiencing skin toxicities linked to EGFR-targeted therapies, with findings suggesting improved symptom control and limited systemic exposure.

Main data that support the findings

The reported data showed that HT-001 led to measurable increases in drug exposure over time while maintaining low levels of absorption into the bloodstream. After repeated dosing, systemic drug exposure — meaning the total amount of drug in the body over time — increased by approximately 76.7%, rising from 45.61 h•ng/mL on Day 1 to 80.60 h•ng/mL on Day 42.

Additional PK measures supported this trend. The average drug level in the body (Cavg) increased from 1.90 ng/mL on Day 1 to 3.36 ng/mL on Day 42, representing an increase of approximately 76.8%. The highest level the drug reached in the body (Cmax) rose from 3.07 ng/mL to 4.56 ng/mL, an increase of about 48.5%. These findings indicate consistent increases in drug levels with continued use.

Importantly for patients, overall systemic exposure remained very low compared with oral treatments. On Day 1, exposure levels were approximately 0.2% of those seen with FDA-approved oral formulations and remained below 0.5% by Day 42, even after repeated dosing. This suggests that the topical formulation may limit how much drug enters the bloodstream.

The drug also showed evidence of sustained presence in the body. Drug levels increased over time in a predictable way with repeated dosing, supporting continued exposure throughout the treatment period. Analyses showed that drug levels rose and declined in a consistent pattern, indicating stable behavior in the body.

In addition to PK findings, HT-001 demonstrated clinical activity. Patients treated with the therapy experienced meaningful reductions in symptom severity related to EGFR therapy-associated skin toxicities. These improvements were sustained over the treatment period, aligning with the observed increase and maintenance of drug exposure.

For patients, EGFR therapy-associated skin toxicities can include rash, dryness or irritation that may affect quality of life. A treatment that reduces these symptoms while limiting systemic exposure may offer a supportive care option during cancer treatment.

Trial details

The reported findings are based on PK, safety and clinical activity analyses of HT-001 in patients with cancer experiencing skin toxicities related to EGFR-targeted therapies. HT-001 is administered as a topical treatment, meaning it is applied directly to the skin rather than taken by mouth.

The study evaluated how the drug behaves in the body over time, comparing measurements from Day 1 to Day 42 of treatment. Researchers assessed multiple indicators of drug exposure to understand how much of the drug entered the body and how long it stayed there with repeated use.

Systemic absorption was also monitored. While some absorption into the bloodstream was observed in a subset of patients, levels remained low overall, which is consistent with how topical treatments are designed to work.

Clinical activity was evaluated through changes in symptom severity. Patients showed reductions in symptoms over the course of treatment, suggesting that HT-001 may help manage skin-related side effects associated with EGFR therapies.

Safety

HT-001 demonstrated a favorable safety and tolerability profile in this analysis. No serious adverse events were reported, representing 0% of patients in the study.

There were also no dose-limiting toxicities observed, meaning that the treatment did not cause side effects severe enough to prevent dose increases or continued use. Additionally, no patients discontinued treatment due to side effects.

The low level of systemic absorption may help explain the safety profile, as less drug circulating in the body can reduce the likelihood of broader side effects.

For patients, these findings suggest that HT-001 may offer a way to manage EGFR therapy-related skin toxicities with limited additional burden from side effects, although further research is needed to confirm these results and guide future use.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.

References

1. “Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic Absorption.” News Release. March 24, 2026.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.