Hoth Therapeutics, Inc. develops clinical-stage therapies for unmet medical needs, with news centered on pipeline progress, regulatory authorizations, intellectual property and financing activity. Company updates frequently cover HT-001, a topical therapeutic for EGFR inhibitor-associated skin toxicities in cancer patients, as well as HT-VA/GDNF metabolic research tied to obesity, MAFLD and related liver-fat pathways.
Other HOTH news themes include patent protection for mast-cell targeting splice-switching oligonucleotide technology, use of the OpenClaw AI-enabled platform for drug-discovery analysis, and capital formation through registered direct offerings and warrant issuances. The company’s public updates generally reflect early-stage pharmaceutical research moving from preclinical work into clinical development.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced its submission of preclinical data on HT-ALZ for presentation at the Alzheimer's Association International Conference from July 31 - August 4, 2022, in San Diego. Dr. Carla Yuede, the lead researcher, will present findings from a sponsored research agreement with Washington University. This data is crucial in evaluating HT-ALZ's potential in treating Alzheimer's disease and aligns with Hoth's mission to address unmet medical needs across various indications, including neurological disorders.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) appointed Dr. John Cirrito and Dr. Carla Yuede to its Scientific Advisory Board to lead the development of HT-ALZ, an oral therapy targeting Alzheimer's disease. Dr. Cirrito, with extensive experience in Alzheimer's research, and Dr. Yuede, a behavioral neuroscience expert, will enhance the company's efforts in this critical area. CEO Robb Knie expressed optimism about their expertise driving the project forward. Hoth also has a sponsored research agreement with Washington University to further the preclinical studies for HT-ALZ.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) has announced positive proof-of-concept data for its HT-ALZ therapeutic in an Alzheimer's disease mouse model. Conducted in collaboration with Washington University, the study showed a significant reduction of amyloid β (Aβ) in mice after treatment with HT-ALZ, indicating its potential to modify plaque formation. HT-ALZ is positioned for streamlined development under the 505(b)(2) regulatory pathway, accelerating its entry into efficacy trials. Future research will assess the impact of HT-ALZ on memory and cognitive function.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) has submitted an Orphan Drug Designation Request to the FDA for HT-KIT to treat mastocytosis. HT-KIT targets the proto-oncogene cKIT, inducing apoptosis in neoplastic mast cells. The Orphan Drug Act offers benefits such as exclusive marketing rights, tax credits, and regulatory assistance, crucial for rare disease treatments. The company aims to leverage these advantages for the development of HT-KIT. Hoth's pipeline includes therapies for various conditions, highlighting its commitment to addressing unmet medical needs.
Hoth Therapeutics (NASDAQ: HOTH) has licensed its cannabinoid therapeutic HT-005 back to Zylö Therapeutics, focusing on treating lupus patients. This agreement allows Hoth to gain equity in Zylö and potential royalties while saving on future development costs, as Zylö will handle the subsequent stages of development. HT-005 has shown efficacy in animal studies, significantly reducing skin plaques associated with cutaneous lupus erythematosus. Hoth aims to develop therapies for various conditions, including atopic dermatitis and psoriasis.
Hoth Therapeutics (NASDAQ: HOTH) announced the initiation of enrollment and dosing for the second cohort in their Phase 1b clinical trial of BioLexa, targeting mild to moderate atopic dermatitis (eczema). This significant milestone is expected to enhance patient outcomes, with the second cohort consisting of current dermatitis patients. The trial is based in Australia, with ongoing patient enrollment. BioLexa aims to tackle chronic infections associated with Staphylococcal biofilms, leveraging a patented formulation to enhance treatment efficacy.
Hoth Therapeutics (NASDAQ: HOTH) has announced a Sponsored Research Agreement with North Carolina State University to advance its cancer treatment, HT-KIT. The study, led by Dr. Glenn Cruse, aims to optimize dosing for aggressive mast cell cancers. HT-KIT targets the cKIT receptor, crucial for cancers like gastrointestinal stromal tumors and acute myeloid leukemia. This collaboration follows Hoth's recent API and drug product manufacturing achievements, aligning with their commitment to push HT-KIT towards clinical trials.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) has entered agreements with STA Pharmaceutical, a subsidiary of WuXi AppTec, for the development and manufacturing of the active pharmaceutical ingredient (API) and formulation of HT-KIT, a therapy targeting mast cell-derived cancers and anaphylaxis. The collaboration aims to expedite the production of HT-KIT, with initial small-scale material expected by Q1 2022. Following this, Hoth plans to pursue a Pre-IND meeting with the FDA.
Hoth Therapeutics (NASDAQ: HOTH) has extended its partnership with REPROCELL to study the HT-003 therapeutic platform in inflammatory bowel disease (IBD), utilizing fresh tissue from ulcerative colitis and Crohn's disease patients. The research will be conducted at REPROCELL's Centre for Predictive Drug Discovery in Glasgow. Both companies have reported promising findings regarding the therapeutic potential of HT-003, focusing on lead candidates for improved responses targeting IBD.
Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced the Human Research Ethics Committee (HREC) approval to initiate Cohort 2 of the Phase 1b clinical trial for BioLexa Lotion, aimed at treating mild to moderate atopic dermatitis in Australia. The randomized, double-blind study will assess the safety and pharmacokinetics of BioLexa Lotion over 14 days in adult patients. Screening for Cohort 2 is set to begin this month, with the company's scientific advisors optimistic about BioLexa's potential in addressing global healthcare needs.