Hoth Therapeutics (HOTH) Announces Submission of Investigational New Drug Application for HT-001

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) on December 1, 2022. The IND application supports a proposed indication of treatment for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. 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.

"With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this IND application brings us one step closer to a new treatment option for underserved cancer patients," said Robb Knie, CEO of Hoth Therapeutics, Inc. "We are excited about 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 as soon as possible after FDA review."

The IND Submission is being submitted 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. During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, and chemistry, manufacturing, controls. Hoth also plans to present clinical trial designs for the IND-opening, phase 2a dose ranging study as well as a proposed follow-up phase 2b safety and efficacy dose extension study; both studies will be conducted in cancer patients receiving EGFR inhibitor therapy.). The FDA will review this application and determine the acceptability of the data before Hoth begins this first clinical trial, which could be as early as Q1 2023. It is possible that the FDA will require additional information.

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