Hoth Therapeutics Inc. (HOTH) Provides Shareholder Update on Therapeutics Pipeline

June 3, 2020 8:08 AM EDT
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Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today provided an update on its pipeline of therapeutics including six compounds in various stages of clinical development, targeting atopic dermatitis, lupus as well as a COVID-19 vaccine and peptide therapeutic.

"Hoth has assembled a unique and portfolio of therapeutics, that is each addressing significant unmet market needs globally," stated Mr. Robb Knie, CEO of Hoth Therapeutics. "We have partnered with some of the most renowned doctor, clinics, and scientific institutions as we strive to bring these innovative therapeutic solutions through the clinic. We have several significant milestones upcoming throughout the rest of 2020 into next year including our human study for BioLexa, targeting the treatment of eczema in adolescents. Management remains committed to developing, and bringing these novel treatments to market and improving the lives of those that require them."

BioLexa Platform (Dermatological)

The BioLexa Platform is a proprietary antimicrobial therapy designed for the treatment of atopic dermatitis or eczema through a non-corticosteroid approach. In January 2020, Hoth concluded its "In-life 28-day animal study." The BioLexa Platform has recorded positive results from its pilot project in 2019 and most recently obtained strong data from initial animal testing. Additionally the Company is preparing to begin its first trial in humans later this year.

VNLG-152 (Dermatological)

Earlier this year, Hoth acquired the full licensing rights of VNLG-152 novel retinamides (Retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases. The Company previously announced that pre-clinical work is underway at Weill Cornell Medicine to examine the efficacy of RAMBAs in blocking acne pathogenic gene expression and carcinogenesis in mice. Currently, Hoth is exploring whether VNLG-152 is capable of blocking this inflammatory response. Immediately after identifying an effective dose of VNLG-152, the researchers will conduct studies on mouse skin to determine if this drug is effective in blocking acne-like inflammation. As the Weill Cornell lab reopens later this month Hoth has intentions to finalize the results of its preclinical work.

WEG-232 (Dermatological)

Last year Hoth entered into a research agreement with the George Washington University (GW) to explore the potential use of WEG-232 for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients. Erlotinib is a drug that is used to combat various cancers and has been known to cause varying degrees of skin rashes, lesions, hair loss and nail changes to patient. A recent research study suggested the topical application of WEG-232 could be very effective in suppressing erlotinib induced-facial rash/hair loss with approximate 71% reduction. It concluded that WEG-232 may be used as an effective intervention to prevent EGFR-TKI-induced cutaneous toxicity. Hoth recently engaged Tergus Pharma as CMO as it looks forward to filing a pre-IND with the FDA this year to receive guidance and begin its human trial.

VaxCelerate (COVID-19)

VaxCelerate is a self-assembling vaccine (SAV) platform designed to protect patients at risk of Coronavirus (COVID-19) infection. VaxCelerate is believed to offer unique advantages over other compounds in combination therapy. In infectious applications, it allows rapid development against viruses and other pathogens. The vaccine focuses on both DNA and internal / external mutated proteins providing the immune system with more potential targets to attack. VaxCelerate is currently in animal trials and Hoth will share those results as the testing completes.

Novel Peptide Therapeutic (COVID-19)

The Company recently licensed technology and intellectual property exclusively from Virginia Commonwealth University ("VCU") for a novel peptide therapeutic to prevent spike protein binding, a potential leading cause of COVID-19. This treatment could be a breakthrough in slowing the transmission of the virus. Current research is being led by inventor, Michael H. Peters, Ph.D., Professor, Department of Chemical and Life Science Engineering at VCU, College of Engineering. The work is being aided, in part, by powerful supercomputers as part of the COVID-19 High Performance Computing Consortium through a virtual system that scientists can use to interactively share computing resources known as the Extreme Science and Engineering Discovery Environment. Hoth hopes to have an update as to further collaboration with VCU in the month ahead.

AEA-loaded Z-pods™ (Lupus)

Developed in partnership with Zylö Therapeutics, Hoth's AEA-loaded Z-pods™ are currently being tested for approval in the treatment of Cutaneous Lupus Erythematosus (CLE). The preclinical results were announced in earlier this year and demonstrated that topical administration with AEA-loaded nanoparticles significantly prevents the development of CLE in an established animal model of lupus. Hoth is currently working with Zylö to plan and coordinate the next phase of development and will update shareholder as soon as more information is available.

Exon Skipping Approach (Allergic Disease)

During November of 2019, Hoth entered into a licensing agreement with North Carolina State University (NC State) to study NC State's Exon Skipping Approach for treating allergic diseases. This Exon Skipping Approach was developed by Dr. Glenn Cruse, Principal Investigator and Assistant Professor in the Department of Molecular Biomedical Sciences at the NC State College of Veterinary Medicine. During Dr. Cruse's research, a new approach for the technique of antisense oligonucleotide-mediated exon skipping to specifically target and down-regulate IgE receptor expression in mast cells was identified. The preclinical studies were initiated in February 2020 and NC State is ready to move to the next stage of the study once laboratories open.



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