On March 26, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing first-in-class therapies for allergic and inflammatory diseases, reported two major developments in the ongoing advancement of its proprietary antisense oligonucleotide (ASO) cancer fighting drug candidate, HT-KIT (Press release, Hoth Therapeutics, MAR 26, 2025, View Source [SID1234651491]).
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The Company has filed amended claims with the U.S. Patent and Trademark Office for its lead ASO technology targeting MS4A6A and FcεRIβ—genes implicated in allergic inflammation and mast cell-related diseases. These refined claims enhance intellectual property protection for HT-KIT and further position it as a novel therapeutic platform with broad clinical potential, including use in treating conditions such as anaphylaxis, mastocytosis, and allergic asthma.
In parallel, Hoth has initiated a GLP-compliant 4-week intravenous toxicity study with a 14-day recovery period in C57BL/6 mice. This preclinical study, conducted in partnership with OnTargetx R&D Inc. and ITR Laboratories, is designed to evaluate the safety profile of HT-KIT in support of upcoming regulatory filings. The study will include multiple dose groups, detailed pathology assessments, and pharmacokinetic profiling.
"These strategic milestones mark significant momentum for HT-KIT as we move toward clinical readiness, "said Robb Knie, CEO of Hoth Therapeutics. "The strengthened patent position and robust preclinical package will be instrumental as we explore partnerships and advance our discussions with regulators."
Next Steps in Development
Hoth Therapeutics is committed to advancing HT-KIT toward clinical evaluation. The company is currently conducting additional preclinical studies to further validate HT-KIT’s efficacy and safety profile, with plans to initiate regulatory discussions for first-in-human trials.