Hoth Therapeutics Completes HT-001 Formulation Development for Upcoming Cancer Patient Clinical Trial
Hoth Therapeutics (NASDAQ: HOTH) has finalized the formulation of HT-001, aimed at alleviating cutaneous toxicities in cancer patients undergoing EGFR inhibitor therapy. This development allows the company to initiate IND-enabling toxicology studies, crucial for the upcoming Phase 2a clinical trial, pending IND approval. The formulation, created with input from top scientific advisors, has shown promising efficacy in preliminary tests. Hoth now focuses on completing necessary regulatory studies for HT-001.
- Completion of HT-001 formulation allows initiation of IND-enabling toxicology studies.
- Preliminary data indicate effective skin protection up to 24 hours post-application.
- High Active Pharmaceutical Ingredients (API) permeation and retention observed.
- None.
NEW YORK, April 12, 2021 /PRNewswire/ -- Today, Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, together with its manufacturing partner, has successfully completed the formulation for HT-001, a treatment for cancer patients suffering from cutaneous toxicities (skin, nails, scalp) due to EGFR inhibitor therapies.
HT-001 is expected to start its Phase 2a trial in pending approval of the IND submission. The finalization of the HT-001 formulation will allow the company to begin IND-enabling toxicology studies and manufacturing of clinical batches for the planned Phase 2a clinical trial.
The HT-001 formulation was developed in conjunction with Scientific Advisor Board Members, Dr. Jonathan Zippin, Dr. Adam Friedman, and Dr. Mario Lacouture, to ensure patient-focused attributes were key inputs of the formulation development. The HT-001 formulation includes a proprietary excipient blend to promote a protective skin barrier function after application. Preliminary data has shown effective skin protection up to 24hours after application based on a transepidermal water loss test model. In vitro permeation testing using human skin has also shown high Active Pharmaceutical Ingredients (API) permeation and retention after application of the selected HT-001 formulation.
"Working with our manufacturing partner, we have been able to successfully optimize the HT-001 formulation for topical application by patients while ensuring API solubility and stability," said Dr. Stefanie Johns, Chief Scientific Officer at Hoth. "We believe this formulation will not only facilitate positive responses in the target areas of toxicity, but also provide the skin protection needed to potentially make patients more comfortable during EGFR inhibitor therapy."
Hoth Therapeutics will now focus on completing the required regulatory studies for HT-001.
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 www.hoththerapeutics.com.
Forward-Looking Statement
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.
Investor Relations Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
Media Relations Contact:
Makovsky
Miriam Brito, Assistant Vice President
Email: hoth-mak@makovsky.com
Phone: (914)-406-0435
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SOURCE Hoth Therapeutics, Inc.
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