FDA Accepts IND for HT-001 for EGFRi-Associated Rash and Skin Disorders

The FDA has accepted an investigational new drug (IND) application for HT-001 for the treatment for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy, according to Hoth Therapeutics, Inc.¹

HT-001 is a topical gel being developed for the treatment of mild to moderate cutaneous toxicities. These include the skin, scalp, and nails, all of which are associated with EGFR inhibitor therapy.

EGFR inhibitors are critical therapeutic agents that can be used to treat patients with non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.

Currently, there are no other agents approved for this indication. With this IND, the agent will be investigated in the phase 2a CLEER trial (NCT05639933) to evaluate its safety and tolerability.²

"We are excited to begin our trial and bring hope to patients who are suffering.With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this trial brings us one step closer to a new treatment option for underserved cancer patients," stated Robb Knie, chief executive officer of Hoth Therapeutics, Inc, in the press release.

In this randomized, double-blind, placebo-controlled, multi-center, dose-ranging, phase 2a study, investigators will evaluate the efficacy, safety, and tolerability of HT-001 when used as a topical treatment for patients with EGFR inhibitor (EGFRi)-induced skin toxicities.

Those included in the study are patients aged 18 years and older who have been prescribed an approved EGFRi and who are expected to begin EGFRI treatment within < 4 weeks of screening. Patients must have an ECOG performance status of 0 to 2, and a predicted life expectancy 3 months or greater.

The study will be conducted in 2 parts. Part 1 is the open-label portion of the trial which will enroll 12 patients and measure the pharmacokinetics (PK) of HT-001. In part 2, the randomized, parallel arm portion of the study, 3 dose strengths of HT-001 gel will be compared with placebo. In these randomized cohorts, patients will be randomly assigned to 1 of the 4 treatment arms in a 2:2:2:1 ratio.

Primary end points of the trial include to determine the proportion of patients with a grade ≤ 1 based on the Acneiform Rash Investigator's Global Assessment scale and PK of HT-001. Investigators will also assess the secondary end points of the change from baseline in pruritus numeric rating scale, pain numeric rating scale, change in acneiform rash severity, time to improvement, time to rescue therapy, EGFRi dose reduction or discontinuation, safety, tolerability, modified draize scale, physical examination, height, and body weight.

Additional outcome measures consist of change in quality-of-life, xerosis severity scale, scoring system for paronychia related to oncologic treatments, progression-free survival, and overall survival.

The trial has an estimated enrollment of 152 patients and a study completion date of January 29, 2025.

“"We look forward to advancing HT-001 into the clinical phase as we believe that this novel therapeutic will be a key treatment in the onco-dermatology space. We anticipate beginning our phase 2a trial in Q1 of 2023,” added Knie, in the press release.

REFERENCES:

Hoth Therapeutics announces FDA acceptance of IND application for HT-001 for the treatment of cancer disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. News release. Hoth Therapeutics, Inc. December 29, 2022. Accessed January 17, 2023. https://prn.to/3IU6xJy

Study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with epidermal growth factor receptor inhibitors (CLEER). ClinicalTrials.gov. Updated December 7, 2022. Accessed January 17, 2023. https://clinicaltrials.gov/ct2/show/NCT05639933?term=HT-001+EGFR&draw=2&rank=1