NEW YORK, Feb. 2, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company today is providing shareholders with an update on its pipeline of novel therapeutics targeting dermatological, COVID-19 and support care indications.
Drug Pipeline Highlights:
- BioLexa Platform: Scheduled to begin Phase 1b clinical trial in Q1 2021
- HT-001: Granted Pre-IND meeting with FDA with responses targeted for February 22, 2021
- HT-003: Received positive preclinical mechanism of action date for acne treatment and renewal of the preclinical research plan
- HT-004: Key proof-of-concept animal model data expected in Q2 2021
Mr. Robb Knie, Chief Executive Officer of Hoth, commented, "Hoth's entire pipeline of innovative novel therapeutics have made significant progress throughout their developmental process over the course of the last year. During that time, we have been able to strengthen our balance sheet to support the acceleration of completing additional testing and moving each asset forward towards approval. Today, we have a unique and diverse portfolio of assets. I believe that we are well-positioned to capitalize on the opportunities that lay ahead and we anticipate that 2021 will serve as an inflection point in our growth trajectory as we remain focused on delivering key updates that will help to drive shareholder value."
The BioLexa Platform
BioLexa is a proprietary antimicrobial therapy designed for the treatment of atopic dermatitis or eczema, through a non-corticosteroid approach. Hoth has received Human Research Ethics Committee (HREC) clearance to commence the first cohort of the Phase 1b clinical trial of BioLexa Lotion for the treatment of mild to moderate atopic dermatitis in Australia. The Company expects to dose the first subject during early 2021 and report interim data from the first cohort of the trial in the second quarter of 2021, followed by initiation of dosing in patients with mild to moderate atopic dermatitis.
The Company has also undergone rapid development with HT-001, a topical formulation under development for the treatment of rash and skin disorders associated with initial and repeat courses of epidermal growth factor receptor (EGFR) inhibitor therapy. Hoth submitted a Pre-IND meeting request in December 2020 for HT-001 with the U.S. Food and Drug Administration (FDA). Hoth has been granted to receive written responses only from FDA that are targeted for delivery on February 22, 2021. Additionally, the company signed an agreement with Charles River Laboratories to initiate preclinical studies of HT-001 in anticipation of selecting the final HT-001 formulation in early 2021.
In May 2020, Hoth introduced HT-002, a novel peptide therapeutic targeted for the treatment of illness associated with SARS-CoV-2 infection (COVID-19) and commenced early preclinical studies at Virginia Commonwealth University in June of 2020. Proof-of-concept virus binding assays are in-progress at Virginia Commonwealth University with a target data readout in March 2021.
The Company completed initial studies examining the ability of HT-003 to block acne pathogenic gene expression in human keratinocytes, the major cell type of the epidermis and the outermost of the layers of the skin. The initial data reported one of the most critical genes for acne pathophysiology, toll-like receptor 2 (TLR2), was significantly inhibited by HT-003. Additionally, no toxicity indicators have been observed in the studies conducted. In vitro mechanism studies and in vivo mouse model studies are expected to start in Q1 2021.
The methodology of HT-004 is a new approach for as an allergy and asthma therapeutic. HT-004 uses antisense oligonucleotide-mediated exon skipping to specifically target and down-regulate IgE receptor expression in mast cells that causes allergic inflammation. Studies were initiated in February 2020 that have demonstrated successful delivery of the API to the lungs. Pre-clinical studies completed in October 2020 have shown positive results supporting the therapeutic mechanism of action. Future development will identify and advance drug candidates for asthma and other allergic diseases using a humanized mouse model, with data readouts expected in Q2 of 2021.
Hoth has established partnership agreement with Zylö Therapeutics Inc., to co-develop a new topical treatment for patients with Cutaneous Lupus Erythematosus (CLE), a chronic autoimmune disease that affects the skin and is associated with a significant burden on patient quality of life. Therapeutic options for CLE are limited to steroids (topical and oral), topical calcineurin inhibitors, and other immunomodulating therapies that could have adverse effects during long-term use. Results from the proof of concept study demonstrated that the novel HT-005 loaded Z-pods™ were effective to reduce skin plaques associated with CLE, with statistical significance demonstrated in the overall average skin score as well as individual skin scores on the head and scapula. Further preclinical studies are being designed and planned to start mid-2021.
In early 2021, Hoth entered into a Non-Exclusive Commercial Evaluation License Agreement with the U.S. Army Medical Research and Development Command (USAMRDC) for a new molecular entity developed by the Walter Reed Army Institute of Research with a novel antibacterial mechanism of action that targets multiple bacterial pathogens. HT-006 has the potential to treat many different types of bacterial infections although Hoth will initially target treatment of serious bacterial infections of the lung, such as hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). Preclinical studies investigating the minimal inhibitory concentration of HT-006 for various multi-drug resistant bacterial species are planned to start in Q1 2021.
The SARS-CoV-2 vaccine is being developed using VaxCelerate, a self-assembling vaccine platform licensed from the Vaccine and Immunotherapy Center at Massachusetts General Hospital by HaloVax, LLC, a biopharmaceutical company and joint venture entity of Voltron Therapeutics, Inc. and Hoth Therapeutics, Inc. VaxCelerate offers two unique elements to combat SARS-CoV-2: a fixed immune adjuvant and variable immune targeting, the combination which is designed to illicit a robust, protective immune response. HaloVax announced successful completion of a small animal safety and immunogenicity study of the first construct in September 2021. A manufacturing agreement for its vaccine portfolio with a global pharmaceutical contract development and manufacturing organization was executed in September 2021. HaloVax is conducting key IND-enabling preclinical studies and is targeting a Pre-IND meeting with FDA by the end of 2021.
In May 2020, Hoth introduced HT-002, a novel peptide therapeutic targeted for the treatment of illness associated with SARS-CoV-2 infection (COVID-19) and commenced early preclinical studies at Virginia Commonwealth University in June of 2020. Proof-of-concept virus binding assays are in-progress at Virginia Commonwealth University with a target data readout in March 2021
On-the-Go SARS-CoV-2 Testing Device System
The On-the-Go SARS-CoV-2 Testing Device System is under development as a point-of-care/patient-use device as an aid in the diagnosis of COVID-19 infection. The On-the-Go SARS-CoV-2 Testing Device is currently in the research phase of development. Proof-of-concept data characterizing the detection of SARS-CoV-2 virus by prototype devices is currently in process.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. Hoth's pipeline development is focused to improve the quality of life for patients suffering from indications including atopic dermatitis, skin toxicities associated with cancer therapy, chronic wounds, psoriasis, asthma, acne, and pneumonia. Hoth has also entered into two different agreements to further the development of two therapeutic prospects to prevent or treat COVID-19. To learn more, please visit https://ir.hoththerapeutics.com/.
This press release includes forward-looking statements based upon Hoth's current expectations which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; our intellectual property; our reliance on third party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section entitled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
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