Hoth Therapeutics’ HT-001 Achieves 100% Response Rate in at least one endpoint in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities.
Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at 3:30PM EST to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists Jonathan Hale Zippin M.D., Ph.D., and Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients. Access/join the event through the following link: https://zoom.us/j/91353016981.
Phase 2a Trial Highlights (CLEER-001)
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100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement
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Over 65% reported reductions in pain and pruritus (itching)
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0% required dose reduction or discontinuation of their EGFRI therapy.
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Topical therapy was well tolerated with no serious adverse events.
NEW YORK, June 24, 2025 /PRNewswire/ — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company developing targeted therapies for rare and serious inflammatory conditions, today announced that its investigational candidate HT-001 met the primary efficacy endpoint in at least one metric in 100% of patients in its ongoing Phase 2a clinical study (CLEER-001) evaluating treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities.
EGFR inhibitors, used widely to treat non-small cell lung cancer (NSCLC), pancreatic, breast, colorectal, and head and neck cancers, are associated with dermatologic side effects in up to 90% of patients, often resulting in painful rashes, pruritus, dryness, nail changes, and alopecia. These adverse events frequently force dose reductions or treatment discontinuation, limiting therapeutic efficacy and patient outcomes.
“HT-001 is a breakthrough candidate with the potential to be the first FDA-approved therapy specifically targeting these EGFRI-related skin toxicities,” said Robb Knie, CEO of Hoth Therapeutics. “The ability to preserve full-dose cancer treatment while improving patient quality of life addresses a critical unmet need across oncology.”
Phase 2a Trial Highlights (CLEER-001)
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100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement
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Over 65% reported reductions in pain and pruritus (itching)
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0% required dose reduction or discontinuation of their EGFRI therapy.
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Topical therapy was well tolerated with no serious adverse events.
HT-001 is a once-daily topical gel formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA). This mechanism mitigates inflammatory pathways triggered by EGFR inhibition, particularly Substance P-driven responses that lead to skin breakdown. By targeting the neuroinflammatory axis, HT-001 reduces symptoms without immunosuppression or systemic toxicity.
Supporting Preclinical Data
In preclinical rat models co-treated with erlotinib (5.85 mg/kg/day), HT-001 significantly reduced:
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Dermatitis and alopecia severity
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Inflammatory markers including Substance P and neutrophil activity
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Disease progression even when HT-001 was introduced after symptom onset.
Additionally, in compassionate-use human cases, complete symptom resolution was observed within one week, with no recurrence for up to three weeks post-treatment discontinuation.
Regulatory and Development Pathway
HT-001 is being advanced under the 505(b)(2) regulatory pathway, enabling the use of existing safety data to accelerate development. Key milestones include:
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IND opened and chronic toxicology completed.
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Phase 2a trial (CLEER-001) currently underway in the U.S.
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Phase 2b/3 trial planning in progress
About Hoth Therapeutics
Hoth Therapeutics, Inc. (NASDAQ: HOTH) is a biopharmaceutical company developing innovative therapies for patients with unmet medical needs. The Company’s pipeline includes treatments targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions. For more information, visit: www.hoththerapeutics.com