Hoth Therapeutics Inc. (NASD: HOTH), a patient-focused biopharmaceutical business, has increased 5.04% to $4.38 in after-hours trading hours on the latest check Thursday after filing an application.
What application did HOTH submit?
On December 1, 2022, Hoth Therapeutics (HOTH) lodged an Investigational New Drug (IND) application to the American Food and Drug Administration (FDA). The claimed indication of treatment for rash and skin conditions related to the epidermal growth factor receptor (EGFR) inhibitor medication is supported by the IND application. Non-small cell lung cancer (NSCLC), colorectal cancer, stomach cancer, squamous-cell carcinoma of the head and neck, and breast cancer can all be effectively treated with EGFR inhibitors.
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This IND application moves Hoth Therapeutics closer to a new therapy option for underprivileged cancer patients because there is presently no particular medication approved for the management of cutaneous toxicity related to EGFRi treatments. As HT-001 will be a significant therapy in the field of onco-dermatology, HOTH will advance the drug into the clinical stage. HOTH planned to start its Phase 2a trial as soon as the FDA approved it.
The 505(b)(2) development pathway is being used for the IND Submission, and HOTH wants to rely on data not gained through the right of reference in order to shorten the nonclinical and clinical program and accelerate the time to NDA submission. In the pre-IND conference with the FDA, HOTH intends to go through the requirements for nonclinical, clinical pharmacology, chemistry, controls, and manufacturing, as well as the overall proposed drug development program for HT-001.
How will HOTH proceed with this?
Additionally, HOTH intends to discuss the proposed phase 2b safety and efficacy dosage extension study and the IND-opening phase 2a dose range study, both of which will be carried out in cancer patients undergoing EGFR inhibitor treatment. Before Hoth Therapeutics (HOTH) launches its initial clinical study, which may happen as early as Q1 2023, the FDA will examine this application and decide if the data is acceptable. It’s probable that the FDA may want further details.