Hoth intends to continue development under Orphan Drug Designation
NEW YORK, Nov. 14, 2023 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for its HT-KIT therapeutic. The Pre-IND meeting was completed through written responses provided by the FDA Nonmalignant Hematology Division of Regulatory Operations for Cardiology, Hematology, Endocrinology, and Nephrology.
HT-KIT is an antisense oligonucleotide that targets the proto-oncogene cKIT by inducing mRNA frame shifting and already has Orphan Drug Designation from the FDA.
Hoth Therapeutics, Inc., is developing the drug product HT-KIT indicated for the treatment of adult patients with AdvSM. HT-KIT is a single-strand phosphorodiamidate morpholino oligonucleotide (PMO).
The purpose of the requested meeting was to gain the Agency's agreement on the suitability the 505(b)(1) regulatory pathway for approval of HT-KIT; adequacy of referenced nonclinical information and the proposed drug development plan to support opening the IND; and to discuss any filing issues the Agency may have with the proposed product.
The Sponsor was granted Orphan Drug Designation for HT-KIT for the treatment of mastocytosis.
Based on the FDA's feedback, Hoth intends to advance its IND-enabling activities for HT-KIT as planned.
"We are very pleased with the outcome of the pre-IND meeting written responses from the FDA," said Robb Knie, CEO of Hoth Therapeutics. "The positive feedback from the FDA is a significant milestone for Hoth in executing our development of HT-KIT and one step closer to getting this exciting cancer fighting therapeutic into the clinic and ready for the patients who would benefit the most."
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. 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.
View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-announces-successful-completion-of-pre-ind-meeting-with-fda-regarding-development-of-hoths-cancer-fighting-ht-kit-301987112.html
SOURCE Hoth Therapeutics, Inc.