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The year 2021 has reportedly been crucial for Hoth Therapeutics Inc. HOTH. The company has moved in its journey to developing new generation therapies for unmet medical needs and delivering value to patients as well as other healthcare stakeholders.

Hoth says that patients are at the forefront of its development strategy, which is guided by the belief that treatment should not make anyone sicker than the disease; Hoth seeks out overlooked drugs that promise to improve treatments and address significant unmet needs for patients.a

The company hopes to find the ideal indications for each asset and partners with leading companies like ReproCELL Inc. 4978 to bring therapies to market.

With development focused on improving the quality of life for patients suffering from conditions such as atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, mast-cell-derived cancers, and anaphylaxis and pneumonia, the year 2022 presents exciting new opportunities for Hoth.

Founded in 2017, the biopharmaceutical company has nine product pipelines it is advancing, and it believes that the pipelines, when combined, can address multibillion-dollar market opportunities.

Milestones 

Here’s a look at the main milestones Hoth reported in 2021 in its drug development:

BioLexa is a patented, proprietary antimicrobial topical formulation being developed to treat diseases mediated by staphylococcal biofilms. Mature bacterial biofilms often result in chronic, recurrent infections that are difficult to treat because of the barrier effect of the biofilm that facilitates antibiotic resistance and avoids immune system mechanisms.

This novel mechanism of action can broadly treat clinical manifestations resulting from staphylococcal biofilm formation.

The BioLexa topical agent is under development for the following indications:

• Atopic dermatitis (eczema)
• Aesthetic dermatology
• Surgical site infections
• Chronic/diabetic wound care

Development Status

The BioLexa Phase 1b/2a study in patients with atopic dermatitis was initiated in the first quarter of 2021.

Milestones

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

HT-001 is a topical formulation under development 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) inhibitor therapy.

EGFR inhibitors are used to treat cancers with EGFR up-regulation (such as non-small cell lung cancer, pancreatic cancer, breast cancer, and colon cancer). 

However, EGFR inhibitors are often associated with dose-limiting skin toxicities that can interrupt treatment. HT-001 is targeted to treat these EGFR-induced skin disorders to allow patients to achieve the best potential outcomes of EGFR therapy.

Development Status

HT-001 is currently in the late preclinical/early clinical stage of development. Hoth had a Pre-Investigational New Drug (IND) meeting with the FDA in the first quarter of Q1 2021 and completed the required safety and toxicology studies in the third quarter.

HT-002 is a novel peptide therapeutic targeted to treat illness associated with SARS-CoV-2 infection (COVID-19). The peptide is under evaluation for potential prophylactic, therapeutic benefits as well.

Development Status

HT-002 is at the preclinical stage of development.

In June 2020, Hoth entered a research agreement with Virginia Commonwealth University (VCU) to develop and optimize the novel peptide therapeutic.

The company’s VaxCelerate product, a self-assembling vaccine (SAV), is currently 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 (collectively called RAMBAs) for a broad spectrum of indications with underlying inflammation as the root cause. These variations include:

• HT-003D is a novel RAMBA under investigation for topical treatment in acne and psoriasis applications.
• HT-003IB is under investigation to treat inflammatory bowel diseases, such as Crohn’s and ulcerative colitis.

Development Status

HT-003D is currently in the late preclinical stages of development. In January 2021, Hoth Therapeutics expanded its research collaboration agreement with Weill Cornell Medicine to better understand 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 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. HT-004 is under investigation for the treatment of asthma using inhalational administration.

Development Status

HT-004 is in the late preclinical stage of development. The preclinical studies are being executed under the guidance of Glenn Cruse, Ph.D., at North Carolina State University. Cruse is also a member of the Hoth Scientific Advisory board.

Milestones

Hoth initiated drug product development in the fourth quarter of 2021.

HT-KIT is 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.

After the successes achieved in 2021, 2022 looks promising for the Hoth Therapeutics drug pipeline. 

Read more about the company’s drug pipelines 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.