Tuesday, February 09, 2021
Hoth Therapeutics, Inc., a biopharmaceutical company, today announced that it has signed an agreement with Camargo Pharmaceutical Services to facilitate the writing and submission of the Investigational New Drug application for HT-001 topical product to the U.S. Food and Drug Administration for initiating the first clinical trial.
Camargo partners with emerging biopharma companies to address unmet medical needs in rare and complex areas by optimizing the path to patients. The Company will write, prepare, and submit an IND in the electronic Common Technical Document (eCTD) format to the US FDA. Initiation of the IND is in anticipation of FDA feedback expected for HT-001 from the Pre-IND meeting responses expected February 22, 2021 and the GLP toxicology studies in process.
HT-001 is a topical product being developed for the treatment of rash and skin disorders associated with initial and repeat courses of epidermal growth factor receptor (EGFR) inhibitor therapy. Currently in the preclinical stage of development of HT-001, the product is being positioned for NDA submission via the 505(b)(2) development pathway, in which Hoth Therapeutics intends to rely on information not obtained through right of reference in order to reduce the nonclinical and clinical program and expedite time to NDA submission.
Mr. Robb Knie, Chief Executive Officer of Hoth, commented, "We are pleased to be progressing through the federal approval process for initiation of clinical trials of our proprietary topical dermatological treatment."