WHAT IS HT-001?
HT-001 is a topical formulation under development for the treatment of patients mild to moderate rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy. EGFR inhibitors are used for treatment of cancers with EGFR up-regulation (such as non-small cell lung cancer, pancreatic cancer, breast cancer, and colon cancer). However, EGFR inhibitors are often associated with dose-limiting skin toxicities that can result in interruption of treatment. HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential outcomes of EGFR therapy.
HT-001 is currently in the late preclinical/early clinical stage of development. Hoth had a Pre-IND Meeting with FDA in Q1 2021 and has scheduled the required safety and toxicology studies to be completed by Q3 2021.
Hoth Therapeutics is planning to submit its IND in Q4 2021 and initiate Phase 2a Clinical study in Q1 2022.
PUBLICATION & NEWS
April 12, 2021 Hoth Therapeutics Completes HT-001 Formulation Development for Upcoming Cancer Patient Clinical Trial
April 6, 2021 Hoth Therapeutics Engages Worldwide Clinical Trials as Contract Research Organization for Phase 2a HT-001 Clinical Trial for Cancer Patients
February 23, 2021 Hoth Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA Regarding Proposed Development of HT-001 For Cancer Patients
February 8, 2021 Hoth Therapeutics Partners with Camargo Pharmaceutical Services for the HT-001 IND, a Treatment for Cancer Patients
January 13, 2021 FDA Grants Hoth Therapeutics Pre-IND Meeting Regarding Proposed Drug Development Plan for HT-001 Treatment for Cancer Patients
January 11, 2021 Hoth Therapeutics to Initiate IND Enabling Studies of HT-001 Treatment for Cancer Patients
December 23, 2020 Hoth Therapeutics Submits Request for a Pre-Investigational New Drug (Pre-IND) Meeting for HT-001, Treatment for Cancer Patients
June 16, 2020 Hoth Therapeutics Enters into Expanded Sponsored Research Agreement with the George Washington University for Dermatology Treatment Candidate HT-001
March 19, 2020 Hoth Therapeutics Announces Positive Preclinical Data of HT-001 Treatment, Developed for Cancer Patients Suffering from Erlotinib-Induced Facial Dermatitis and Hair Loss
January 15, 2020 Hoth Therapeutics Exercises Patent Licensing Option with the George Washington University to Further Develop a Therapeutic for Cancer Patients Suffering Cutaneous Changes Like Rash and Hair Loss, as Well as Other Neurogenic Inflammation Side Effects
November 14, 2019 Hoth Therapeutics Initiates Preclinical Study Including Topical Form of HT-001 for Dermatological Treatment Relating to Side Effects of Cancer Medication
June 27, 2019 Hoth Therapeutics, Inc. Enters into Sponsored Research Agreement with the George Washington University