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NEW YORK - Hoth Therapeutics, Inc. (NASDAQ:HOTH), a small-cap biotech company with a market capitalization of $17.17 million, announced on Wednesday that its cancer treatment candidate HT-KIT demonstrated positive safety results in preclinical studies, showing dose-responsive effects without observable toxicity. According to InvestingPro data, the company’s stock has surged over 63% in the past six months, reflecting growing investor interest in its pipeline.
The multi-dose study revealed that liver weight increased from 1.11g to 1.32g as dosage increased from 0 to 3.0 mg/kg, indicating pharmacological engagement with the target. According to the company, kidney, spleen, thymus, and other organ weights remained stable across all treatment groups, with no gross pathology or visible lesions observed in any treated animals.
"These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission."
HT-KIT targets the c-KIT pathway and is being developed as an oncology treatment. The company plans to initiate Good Laboratory Practice (GLP) toxicology studies, followed by an Investigational New Drug (IND) application submission.
Hoth Therapeutics focuses on developing treatments for rare and inflammatory diseases. The preclinical results reported were from an animal study that serves as a preliminary step before human clinical trials can begin.
The information in this article is based on a company press release statement.
In other recent news, Hoth Therapeutics has secured a Japanese patent for its HT-KIT platform technology, which targets mast cell diseases. The patent provides exclusive protection until 2039, highlighting the company’s strategic focus on global markets. Additionally, Hoth is advancing its oncology treatment, HT-001, which is aimed at addressing skin toxicities from cancer therapies. The company plans to expand access through a compassionate use program, enabling patients who are not eligible for clinical trials to receive the treatment.
Hoth Therapeutics has also reported significant preclinical results for HT-KIT, showing over an 80% reduction in KIT expression and tumor growth inhibition in specific cancer models. The company is preparing to submit an Investigational New Drug application to the FDA in 2026. Furthermore, Hoth’s subsidiary, Merveille.ai, has completed the payment of fees for an international patent application concerning hair loss treatment. This step is part of the company’s efforts to strengthen its intellectual property portfolio.
These developments underscore Hoth Therapeutics’ commitment to advancing its pipeline and securing market exclusivity for its innovative therapies.
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