Hoth Therapeutics, Inc. issued the following announcement on Dec. 23.
Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, announced the request for a Pre-Investigational New Drug (IND) meeting to the U.S. Food and Drug Administration (FDA) to discuss the proposed drug development program for HT-001, a topical drug formation under development for the treatment of 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.
Cancer patients receiving EGFR inhibitor therapy often require repeat courses to achieve effective cancer treatment, and >50% of patients have significant dermatological side effects within the first 2 weeks of treatment that persist even after stopping EGFR therapy. These skin toxicities can severely impact patient quality of life and can result in reduction of EGFR inhibitor dose or 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, as there are currently no approved drugs to specifically treat EGFR inhibitor-induced skin disorders.
In July 2019 Hoth Therapeutics entered into a Sponsored Research Agreement with the George Washington University (GW) to explore preclinical pharmacology studies with topically administered HT-001.
Currently in the preclinical stage of development of HT-001, Hoth Therapeutics anticipates a meeting with the FDA to be scheduled during the first quarter of 2021. HT-001 is being positioned for 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. 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.
"Palliative care treatment for cancer patients continues to be an underserved segment of the market that our HT-001 product has an opportunity to provide patients with a better quality of life during their cancer treatment," stated Robb Knie, Chairman and CEO of Hoth Therapeutics. "We look forward to working closely with the FDA on our Phase 2a and Phase 2b trial designs and advancing HT-001 through the research and development process."
About Hoth Therapeutics, Inc.
Hoth 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. 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 .
Original source can be found here.
