Epidermal growth factor receptor (EGFR) inhibitors are changing the way that many types of cancers are treated, but these drugs can cause adverse skin reactions including acneiform rashes in at least half of patients.
Now, Hoth Therapeutics, Inc. has received approval from the University of Miami to enroll patients for its first-in-human Phase 2a clinical trial of HT-001 topical gel for the treatment of skin toxicities associated with EGFR inhibitors. There are no other drugs approved for this indication.
EGFR signaling helps maintain skin homeostasis, and inhibition results in high influx of inflammatory cells and production of proinflammatory cytokines in the skin. HT-001 gel may inhibit recruitment and activation of immune cells, reducing inflammation, the company states.
“We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001,” says Hoth Therapeutics Chief Executive Officer Robb Knie in a news release. “ Coupled with approval at Washington University of St. Louis and MD Anderson Cancer Center, University of Miami will be our third site approved to host our trial and bring hope to cancer patients suffering from skin toxicities associated with EGFRi treatments.”
The study aims to determine the therapeutic effect of HT-001 in patients who develop acneiform rash while on an EGFR inhibitor using the acneiform rash investigator’s global assessment scale and to evaluate the safety of HT-001 during treatment. Study participants will apply HT-001 Gel once per day for 6 weeks. The study will be completed in 2 periods: the first period is open-label, and all patients will receive HT-001 topical gel with the active ingredient; the second period is blinded and patients will be randomized to receive one of three concentrations of HT-001 or placebo. Researchers will compare HT-001 to the placebo in the second period to see if HT-001 provides a significant treatment effect.
Updates on the trial are expected in the first quarter of 2024, he says. Stay tuned.
