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Investing.com -- Hoth Therapeutics Inc (NASDAQ:HOTH) stock rose 2.5% after the clinical-stage biopharmaceutical company announced positive results from its ongoing Phase 2a clinical trial evaluating HT-001 for the treatment of skin toxicities caused by cancer drugs.
The company reported that its investigational candidate HT-001 met the primary efficacy endpoint in at least one metric in 100% of patients enrolled in the CLEER-001 study. The trial is evaluating the treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities, which affect up to 90% of cancer patients using these medications.
According to the trial data, over 65% of patients reported reductions in pain and itching, and none required dose reduction or discontinuation of their cancer therapy. The topical treatment was well-tolerated with no serious adverse events reported.
"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.
HT-001 is a once-daily topical gel formulated with an FDA-approved neurokinin-1 receptor antagonist. The treatment works by mitigating inflammatory pathways triggered by EGFR inhibition, particularly Substance P-driven responses that lead to skin breakdown.
The company is advancing HT-001 under the 505(b)(2) regulatory pathway, which may accelerate development by leveraging existing safety data. Hoth has completed chronic toxicology studies and is currently planning Phase 2b/3 trials.
EGFR inhibitors are widely used to treat various cancers including non-small cell lung cancer, pancreatic, breast, colorectal, and head and neck cancers, but their dermatologic side effects often force dose reductions or treatment discontinuation.
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