Shares of Hoth Therapeutics (NASDAQ: HOTH) doubled after the company announced FDA acceptance of its Investigational New Drug (IND) application for HT-001, a therapeutic for the treatment for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy.

The company noted that EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.

Hoth Therapeutics CEO Robb Knie stated: "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. 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.”

The company is now enrolling for a Phase 2a clinical trial, which is planned to commence in early 2023.

The trial will include a randomized, double-blind, placebo-controlled, multi-center Phase 2a dose-ranging study to evaluate the efficacy, safety, and tolerability of HT-001 for the treatment of EGFRI-induced skin toxicity.

The study will include adult patients scheduled to receive initial or repeat EGFRI therapy.

The study will be conducted in 2 periods: Part 1, an open-label cohort consisting of 12 patients to measure pharmacokinetics of HT 001 gel followed by Part 2, a randomized, parallel arm study comparing 3 dose strengths of HT-001 gel to placebo (HT 001 vehicle). Patients in the randomized cohorts will be randomly assigned to 1 of the 4 treatment arms in a 2:2:2:1 ratio (active groups = 2: placebo = 1).

All patients in both open-label and blinded cohorts will apply the study drug once a day to each area affected with cutaneous toxicity up to 30% body surface area (BSA) involvement, inclusive of skin, scalp, and nails.

The company says that the goal of the study will be to determine the minimum efficacious dose strength(s) for further investigation. The dose effect, together with the application site safety assessments, and therapeutic effects based on the primary and secondary endpoints will be evaluated.

Shares of Hoth Therapeutics trade on the NASDAQ under the ticker symbol HOTH. For more information visit www.hoththerapeutics.com.