Hoth Therapeutics, a biopharmaceutical company based in New York, has announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for HT-001, a therapeutic treatment for cancer disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy.
EGFR inhibitors are a critical class of therapeutic agents used to treat a range of cancers, including non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer. However, the use of these drugs can sometimes be accompanied by the development of skin toxicities, including rash and other disorders, for which there is currently no approved treatment.
HT-001 is being developed as a potential treatment option for these skin toxicities. The acceptance of Hoth Therapeutics’ IND application by the FDA means that the company can now proceed with clinical testing of HT-001. Hoth Therapeutics CEO Robb Knie said in a statement: “With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this trial brings us one step closer to a new treatment option for underserved cancer patients… We anticipate beginning our Phase 2a trial in Q1 of 2023.”
The Phase 2a trial will evaluate the safety and efficacy of HT-001 in patients suffering from skin toxicities caused by EGFR inhibitor therapy. If successful, the trial could pave the way for HT-001 to be approved as a treatment option for these patients, providing much-needed relief to those suffering from these adverse effects.