Hoth Therapeutics Reports Being Ready For 2022 As It Anticipates Major Milestones In Drug Pipeline

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Hoth Therapeutics Inc. HOTH looks to take things a notch higher this year. 

The clinical-stage biopharmaceutical company plans to ramp up its work on the portfolio of clinical and preclinical drug candidates it is currently working on and explore opportunities for the future.

Since 2017 the company has been working on drug candidates for patients suffering from indications such as atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell-derived cancers, and anaphylaxis and pneumonia.

With foundations laid and achievements in 2021, Hoth is looking forward to marking some key milestones in 2022, which may present new opportunities for the company.

Hoth is guided by the belief that treatment should not make anyone sicker than the disease and it seeks out overlooked drugs that promise to improve treatments and address significant unmet needs for patients. As of the end of 2021, the company had nine drugs it is advancing through its pipeline.

Recap of 2021 Milestones

Milestones Hoth achieved in its drug development in 2021 include:

• In the first quarter of 2021, Hoth initiated its Phase 1b/2a study for BioLexa, which can broadly treat clinical manifestations resulting from Staphylococcal biofilm formation. BioLexa is a topical agent under development to treat atopic dermatitis (eczema), aesthetic dermatology, surgical site infections, and chronic/diabetic wound care. 

After receiving an interim data readout from the clinical study, BioLexa received approval to commence Cohort 2 in a clinical trial to treat atopic dermatitis patients.

• The company is also working on HT-001, a topical formulation for treating patients with mild to moderate rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR). EGFR inhibitor therapy treats non-small cell lung cancer, pancreatic cancer, breast cancer, and colon cancer. HT-001 is currently in the late preclinical/early clinical stage of development. Hoth had a pre-investigational new drug (IND) meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2021 and completed the required safety and toxicology studies in the third quarter.
• In June 2020, Hoth entered a research agreement with Virginia Commonwealth University (VCU) to develop and optimize HT-002, a novel peptide therapeutic targeted to treat illness associated with SARS-CoV-2 (COVID-19). The peptide is under evaluation for potential prophylactic, therapeutic benefits as well. HT-002 is at the preclinical stage of development.
• Hoth’s VaxCelerate product, a self-assembling vaccine (SAV), is in the late preclinical stage of development. It recently entered into a sponsored research agreement for the On-the-Go COVID-19 testing device.
• HT-003 is being developed as a platform of retinoic acid metabolism (RAMBAs) for a broad spectrum of indications with underlying inflammation as the root cause. Read about HT-003 variations here.

HT-003D is in the late preclinical stages of development. In January 2021, Hoth Therapeutics expanded its research collaboration agreement with Weill Cornell Medicine to learn more about the therapeutic mechanism of HT-003D for treating acne and other inflammatory skin diseases. The research also explored the safety of HT-003D in murine models.

• HT-004 is under investigation for the treatment of asthma using inhalational administration. It is in the late preclinical stage of development. Hoth initiated drug product development in Q4 2021. HT-OO4 is a potential disease-modifying agent that uses gene therapy-targeted methods to reduce mast cell responses to immunoglobulin E (IgE)-directed antigens, which is one of the key mechanisms in the pathophysiology of asthma, atopic dermatitis, and other allergic diseases.
• Hoth licensed HT-005 back to Zylö Therapeutics. HT-005 is being developed as a treatment for cutaneous lupus erythematosus (CLE), a painful skin disease that affects a majority of patients with lupus.
• Hoth entered a research agreement with the University of Cincinnati Research Institute to study HT-006, a potential antibiotic treatment for multidrug-resistant (MDR) bacterial lung infections like hospital-acquired pneumonia, cystic fibrosis, and chronic obstructive pulmonary disease.
• Hoth is developing HT-KIT for cell-derived cancers and anaphylaxis. After publishing white papers on the proof-of-concept studies, Hoth announced the submission of an orphan drug designation request for HT-KIT to treat mastocytosis.

Projected Milestones For 2022

Hoth believes the nine drugs it is advancing, when combined, can address a multibillion-dollar market opportunity. The company has reported that it has enough cash on hand to accomplish all of the clinical and preclinical programs in its pipeline this year.

In the first quarter of 2022, Hoth will conduct more preclinical research on the topical CLE treatment, HT-005. It will also proceed with studies of HT-006, the MDR bacterial lung infection treatment.

Hoth and STA Pharmaceutical, a wholly-owned subsidiary of Wuxi Apptec ADR WUXAY, plan to begin drug product development for their cancer therapeutic in early 2022. They also plan to start preliminary toxicology studies by the second quarter.

Read more about the company’s drug pipeline at ir.hoththerapeutics.com/pipeline-overview and ir.hoththerapeutics.com/.

This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice.