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Hoth Therapeutics Announces it Received FDA Approval to Expand HT-001 Clinical Trial to Treat Severely Ill Patients
Patients will be able to enroll in trial at any time and regardless of failure from other therapeutics NEW YORK, Jan. 18, 2024 /PRNewswire/ -- Hoth
About this update from Hoth Therapeutics, Inc.
[{"type":"text","content":"Patients will be able to enroll in trial at any time and regardless of failure from other therapeutics\nNEW YORK, Jan. 18, 2024 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, announced today that it has received U.S. Food and Drug Administration (FDA) clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which is being developed as a potential treatment for cancer patients undergoing treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRI). The trial is being conducted under Hoth's open Investigational New Drug Application (IND) for HT-001.\n\n \n \n \n \n \n \n\n \n\"We are extremely pleased to announce clearance of our clinical trial optimization plan for HT-001. Armed with positive initial data and a clean safety profile to date, we believe that these protocol amendments could ultimately result in the generation of a highly compelling data set which could support patients suffering from the effects of EGFRI cancer treatment. These latest developments underscore Hoth Therapeutics' continued commitment to delivering a safe and effective treatment for this very underserved patient population,\" said Robb Knie, Chief Executive Officer of Hoth Therapeutics.\nThis is a randomized, double-blind, placebo-controlled, multi-center Phase 2a dose-ranging study to evaluate the efficacy, safety, and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity. The study will include adult patients (≥ 18 years of age) receiving EGFRI therapy.\nThe study will be conducted in 2 parallel cohorts: Part 1, an open-label cohort consisting of 12 patients to measure pharmacokinetics of HT 001 gel and 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).\nAll 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.\nThe goal of the study is to determine the minimum efficacious dose strength(s) for further investigation. The dose effect, together with the ap...