Topical gel shows promise in treating cutaneous events from EGFR inhibitor cancer therapy

Key takeaways:

• Phase 2a interim data show 100% of patients achieving the primary endpoint of skin toxicity improvement.
• Also, 66% of patients report a reduction in skin pain and itching.

A novel topical gel, HT-001, has shown potential as a treatment for cutaneous side effects from epidermal growth factor receptor inhibitor cancer therapy, according to a Hoth Therapeutics press release detailing phase 2a interim data.

“These results are a significant milestone, underscoring HT-001's potential to transform patient care by mitigating debilitating skin toxicities while maintaining critical cancer treatments,” Robb Knie, CEO of Hoth Therapeutics, said in the release. “Our data highlight HT-001's strong safety profile and the potential for it to set a new standard of care in this underserved area.”

According to a 2021 study by Joly-Tonetti and colleagues, 45% to 100% of patients treated with epidermal growth factor receptor inhibitors (EGFRi) for cancer experience adverse skin reactions including skin inflammation, infection, pruritus and dryness.

As a result, patients must often discontinue the drug to prevent severe skin impairments — a course of action which can interfere with their cancer treatment.

HT-001 is a novel topical gel indicated for the treatment of mild to moderate cutaneous toxicities associated with EGFRi cancer therapy, according to Hoth Therapeutic’s website. With no other drugs approved for this indication, the emergence of these new, phase 2a interim data creates a potentially “encouraging” path for cancer patients suffering from this side effect, according to the press release.

These results showed that 100% of the patients receiving HT-001 treatment reached the study’s primary endpoint of Acneiform Rash Investigator Global Assessment Scale score less than or equal to 1, indicating a significant skin toxicity improvement, by week 6. Additionally, 66% of patients also reported reduced skin pain and itching.

All patients were able to continue their initial EGFRi dosage for their cancer. There were no treatment-related adverse effects.

The company is currently developing HT-001 with intentions of submitting a new drug application via the 505(b)(2) regulatory pathway, according to the company website.

References:

• Introduction to HT-001 topical gel. https://hoththerapeutics.com/wp-content/uploads/2021/05/HOTH-HT-001_Non-Confidential_MAY2021-1.pdf. Published May 2021. Accessed Jan. 7, 2025.
• Joly-Tonetti N, et al. BMC Cancer. 2021;doi:10.1186/s12885-020-07685-5.