Enhancing shareholder value through exceptional business performance and practices, and through responsible and effective communication with its shareholders.
NEW YORK, Nov. 2, 2020 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced key upcoming milestones towards the commercial development of the novel COVID-19 products currently being developed. Hoth Therapeutics has cast a wide net to contribute to the fight against COVID-19 that includes: HT-002 peptide therapeutic targeted to treat symptoms associated with COVID-19, the On-the-Go SARS-CoV-2 Testing Device, and VaxCelerate SARS-CoV-2 vaccine.
HT-002 is a novel peptide therapeutic targeted for the treatment of illness associated with SARS-CoV-2 infection (COVID-19 disease).
SARS-CoV-2 live virus inhibition test data is expected to be available in December 2020, which would characterize the therapeutic potential of the HT-002 peptide in an in vitro model. Pending results of the study, Hoth Therapeutics intends to pursue formulation development, preclinical safety testing, and meetings with the US Food and Drug Administration ("FDA") in 2021 for HT-002.
On-the-Go SARS-CoV-2 Testing Device
The On-the-Go SARS-CoV-2 Testing Device System is the first of its kind technology under development as a point-of-care/patient-use device as an aid in the diagnosis of COVID-19 infection. The system uses a nanohole array (NHA)-based plasmonic system that is being designed for high sensitivity and selectivity detection of SARS-CoV-2 virus with rapid reporting of results.
The On-the-Go SARS-CoV-2 Testing Device is currently in the research phase of development. Proof-of-concept data supporting sensitive detection of SARS-CoV-2 virus by prototype devices is expected by the end of 2020, with further studies characterizing specificity of the device contemplated in 2021. The initial research level data is expected to be used to support a pre-Emergency Use Authorization (EUA) meeting with the US Food and Drug Administration in 2021, which will be focused on the verification and validation requirements to obtain EUA for a non-laboratory use device.
"COVID-19 disease remains a critical unmet medical need in the US and there still exists a significant gap for effective vaccines, safe and efficacious therapeutics, and rapid, accurate diagnostic tests that can be performed by patients at home. We are pushing an aggressive development timeline for each of the COVID-19 products to help fill this gap," stated, Stefanie Johns, PhD, Chief Scientific Officer of Hoth Therapeutics. "We look forward to sharing our progress on these COVID-19 products as we stay focused on the development tasks at hand towards commercialization."
VaxCelerate SARS-CoV-2 Vaccine
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. 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.
Proof-of-concept mouse model data has recently been generated with the SARS-CoV-2 vaccine candidate that supports an immune response is achieved after inoculation. Additional studies are planned to optimize the vaccine formulation and collect additional preclinical data in a humanized-mouse model to position the vaccine candidate for initiating human clinical trials.
About Hoth Therapeutics, Inc.
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for dermatological disorders. Hoth's pipeline has the potential to improve the quality of life for patients suffering from indications including atopic dermatitis, chronic wounds, psoriasis, asthma and acne. Hoth has also recently entered into two different agreements to further the development of two different therapeutic prospects to prevent or treat COVID-19. To learn more, please visit www.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.
SOURCE Hoth Therapeutics, Inc.