Hoth Therapeutics, Inc. (NASDAQ: HOTH) has made significant strides in strengthening its intellectual property portfolio with new patent filings for two key drug candidates, positioning the biopharmaceutical company for continued development of its innovative therapeutics pipeline.
The company recently received an official Filing Receipt from the United States Patent and Trademark Office (USPTO) for a new patent application related to the proprietary formulation of HT-001, Hoth's lead clinical asset. This application builds upon an already approved patent for the compound and seeks to expand protection for the unique composition and delivery method of HT-001.
HT-001 is being developed as a novel topical treatment specifically designed to alleviate dermatologic side effects commonly experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor therapy. The formulation-specific filing aims to further secure Hoth's intellectual property rights for this specialized therapeutic approach.
HT-KIT Program Advances with Patent Filing and Preclinical Study
In parallel, Hoth has filed amended claims with the USPTO for its proprietary antisense oligonucleotide (ASO) cancer-fighting drug candidate, HT-KIT. These refined claims target MS4A6A and FcεRIβ genes, which are implicated in allergic inflammation and mast cell-related diseases.
The enhanced patent protection positions HT-KIT as a novel therapeutic platform with broad clinical potential, including applications for treating conditions such as anaphylaxis, mastocytosis, and allergic asthma.
"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."
Preclinical Studies Underway
Complementing its intellectual property initiatives, Hoth has initiated a GLP-compliant 4-week intravenous toxicity study with a 14-day recovery period in C57BL/6 mice for the HT-KIT program. 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 comprehensive study will include multiple dose groups, detailed pathology assessments, and pharmacokinetic profiling to establish a thorough safety profile for the drug candidate.
Development Pipeline and Future Plans
Hoth Therapeutics is focused on developing first-in-class therapies for allergic and inflammatory diseases. 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.
For HT-001, the expanded patent protection strengthens the company's position as it continues development of this topical treatment addressing an important unmet need for cancer patients experiencing dermatologic side effects from EGFR inhibitor therapy.
These dual advancements in Hoth's patent portfolio reflect the company's strategic approach to building a diverse pipeline of novel therapeutics with strong intellectual property protection, potentially enhancing both patient outcomes and shareholder value.
