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FDA Grants Hoth Therapeutics Pre-IND Meeting Regarding Proposed Drug Development Plan for HT-001 Treatment for Cancer Patients
NEW YORK, Jan. 13, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced the Pre-IND meeting requested on
About this update from Hoth Therapeutics, Inc.
[{"type":"text","content":"NEW YORK, Jan. 13, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced the Pre-IND meeting requested on 22 December 2020 for HT-001 with the U.S. Food and Drug Administration (FDA) Division of Dermatology and Dental Products has been granted to receive written responses only from FDA that are targeted for delivery on February 22, 2021.\n\n \n \n \n \n \n \n\n \nHT-001 is a topical formulation under development for the treatment of rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy for patients undergoing treatment for cancer.\nThe Pre-IND meeting topics include the acceptability of the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, chemistry, and manufacturing controls. The proposed clinical trial designs for the first clinical studies (phase 2) in the HT-001 program are also included in the Pre-IND meeting topics to receive FDA feedback. \n\"We are looking forward to receiving feedback from FDA to continue advancing the HT-001 development program towards the clinic as efficiently as possible,\" stated Robb Knie, Chairman and CEO of Hoth Therapeutics. \"Receiving feedback from FDA in February positions us well to achieve our planned IND-enabling development activities on time with the eventual goal of initiating the first HT-001 clinical trial in patients.\"\nAbout Hoth Therapeutics, Inc.\nHoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth's pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne and other immunological disorders. Hoth has also recently entered into two different agreements to further the development of two different therapeutic prospects to prevent or treat COVID-19. To learn more, please visit www.hoththerapeutics.com.\nForward-Looking Statement\nThis press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigat...