Hoth Therapeutics Provides Shareholder Update on COVID-19 Initiatives and Dermatological Therapy Pipeline

Hoth Therapeutics, Inc., a biopharmaceutical company, today is providing shareholders with a update on its COVID-19 initiatives including vaccine and real-time, breath-based mobile testing device as well as its dermatological therapy pipeline.  

Mr. Robb Knie, Chief Executive Officer of Hoth, commented, "By leveraging our platform, expertise and strategic relationships, we have made significant progress in advancing our robust therapeutics pipeline. Additionally, we've been able to invest in strategic, undervalued assets – all amidst the ongoing global pandemic. Since inception, we have acquired the rights to assets that addresses global issues, via our partnership for a COVID-19 vaccine, novel peptides and medical device. While continuing to evaluate these assets, we recently submitted for ethics board approval in Australia for our lead therapy candidate, BioLexa, for Atopic Dermatitis, to launch our clinical study in humans during the second half of this year. Going forward, we have several initiatives that we believe will help enhance shareholder value."

Dermatological Therapeutics Pipeline:

The BioLexa Platform, Hoth's leading therapy candidate, is a proprietary antimicrobial therapy designed for the treatment of atopic dermatitis or eczema, through a non-corticosteroid approach. Recently, Hoth submitted its planned clinical study for approval of BioLexa treatment of Atopic Dermatitis to the Bellberry Human Research Ethics Committee in Australia. Hoth anticipates to begin the study during the second half of 2020.

Hoth has executed a licensing agreement with Isoprene Pharmaceuticals, Inc. to acquire the rights to VNLG-152, a novel retinamides (Retinoic acid metabolism blocking agents, or RAMBAs) for the treatment of dermatological diseases. 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 is working closely with the Weill Cornell lab to finalize the results of its preclinical work.

The Company entered into a further 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 animal 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. Hoth has partnered with Tergus to produce GMP materials in hopes of a Pre-IND consultation with the FDA before year end.

Gene Therapy

After COVID-19 delays the Company has begun the initiation of a preclinical study for the treatment of asthma and allergic inflammation in collaboration with North Carolina State University (NC State). The study has begun the delivery and distribution of nebulized particles which will enable the therapeutic oligonucleotide (oligo), short DNA and RNA molecules that have a wide range of applications in gene testing. Hoth has appointed Dr. Glenn Cruse to its Scientific Advisory Board and will oversee the Company's gene therapy program's advancements. Hoth also 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. These findings set a breakthrough for allergic diseases as they are driven by the activation of mast cells and the release of mediators in response to IgE-directed antigens.

COVID-19 Initiatives:

Hoth also recently licensed the intellectual property rights relating to the development of a medical device that has the potential to allow public health professionals to immediately diagnose COVID-19 infection via breath sample and track through a mobile device from the George Washington University ('GW').  Hoth is working to share further data about the device and determine how few virus particles can be detected using the device to help counteract spread and allow for quicker and more efficient testing and tracing.  The laboratory team at GW will consist not only of virologists but of engineers and engineering postdoctoral students, all of whom have to be trained to handle deactivated pathogens to help speed the development of this program. 

VaxCelerate is a self-assembling vaccine (SAV) platform designed to protect patients at risk of COVID-19 infection believed to offer unique advantages over other compounds in combination therapy. In infectious applications, it allows rapid development against viruses and other pathogens. Preclinical animal testing of the first construct of VaxCelerate against COVID-19 has commenced. Hoth believes, along with its joint venture partner HaloVax, to have results of this animal study and additional next steps in early Q4 2020.

Additionally, Hoth has licensed the technology and intellectual property for a novel peptide therapeutic to prevent spike protein binding, which may be a leading cause of COVID-19, and potentially slow its transmission. Dr. Michael Peters at VCU has begun further pre-clinical testing through a Scientific Research Agreement that Hoth executed with VCU.

Hoth filed its Form 10-Q with the Securities and Exchange Commission for the period ended June 30, 2020 on August 13, 2020.