Hoth Therapeutics Announces the selection of NUVISAN for Manufacturing HT-001 Drug Batches for CLEER-001 Clinical Study for Cancer Patients
Hoth Therapeutics, Inc. (NASDAQ: HOTH) has partnered with NUVISAN, a European CRO/CDMO, to manufacture clinical batches of its HT-001 topical drug for the upcoming CLEER-001 trial targeting skin toxicities in cancer therapy. This phase 2a randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of HT-001 for patients undergoing EGFR inhibitor treatments at 14 sites in the United States. The collaboration aims to leverage NUVISAN's expertise in topical formulation to enhance the clinical development of this therapy.
- Partnership with NUVISAN for clinical batch manufacturing of HT-001 enhances trial preparations.
- CLEER-001 trial aims to address unmet needs in cancer treatment-related skin toxicities.
- Dependence on third-party manufacturing could introduce supply chain risks.
- Potential delays or complications in the clinical trial process remain a concern.
NEW YORK, Feb. 9, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced it has signed an agreement with NUVISAN, a European CRO/CDMO with topical manufacturing capabilities in Sophia-Antipolis, France, to manufacture clinical batches of HT-001 topical drug product for its upcoming CLEER-001 clinical trial for cancer patients. HT-001 is a novel topical therapy in development for treatment of cutaneous toxicities associated with Epidermal Growth Factor Receptor (EGFR) inhibitor cancer therapy.
NUVISAN group, our selected CRO/CDMO service provider, offers integrated solutions along the drug development value chain, from target identification to the proof of concept in patient with all supporting services (Chemistry, DMPK, GMP synthesis, formulation development, analytics, bioanalysis, clinical trial supplies and Phase 1 clinical studies). With its rich dermatological heritage, NUVISAN France specializes in innovative topical formulation development and GMP manufacturing.
"Having a manufacturing service provider like NUVISAN with unparalleled experience and quality in topical formulations really sets the upcoming CLEER-001 phase 2a clinical trial up for success," commented Robb Knie, CEO of Hoth Therapeutics, Inc. "We look forward to partnering with NUVISAN from clinical manufacturing of HT-001 and beyond to bring this much needed topical therapy to cancer patients receiving EGFR inhibitor therapy globally."
"NUVISAN is excited to work with such an inspiring biotech to accelerate the development of this innovative therapy. Hoth Therapeutics is aiming to improve the lives of cancer patients around the world and this is the kind of challenge that our highly skilled and experienced topical scientists like to take on." commented Pierre Diebolt, Managing Director of NUVISAN France.
The CLEER-001 clinical trial is a randomized, placebo-controlled, phase 2a dose-ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFR inhibitors. The study is planned to include 14 clinical sites in the United States.
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, mast-cell derived cancers and anaphylaxis 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/.
About NUVISAN Group
NUVISAN Group is a 1000+ employee CRO/CDMO (Contract Research Organization/Contract Development Manufacturing Organization) specialized in drug development. The company provides a wide range of services along the drug development value chain, from early hit identification to late stage clinical research with all supporting services (Medicinal Chemistry, DMPK, GMP synthesis, formulation development, analytical, bioanalysis, Phase 1 clinical trials, clinical trial supplies). Founded in 1979, its operations run at six different sites in Europe (Neu-Ulm-HQ, Berlin, Grafing, Gauting, Waltrop in Germany and Sophia-Antipolis in France). For more information, visit www.nuvisan.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 Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials, the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing, timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's 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 undue 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 Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth 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 of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update 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 Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
NUVISAN Contact:
Email: william.thomas@nuvisan.com
www.nuvisan.com
Phone: +33 4 93 95 70 73
View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-announces-the-selection-of-nuvisan-for-manufacturing-ht-001-drug-batches-for-cleer-001-clinical-study-for-cancer-patients-301478625.html
SOURCE Hoth Therapeutics, Inc.
FAQ
What is Hoth Therapeutics planning with NUVISAN?
What is the CLEER-001 clinical trial about?
Where will the CLEER-001 trial be conducted?
What are the goals of the HT-001 drug?
What is the significance of the partnership with NUVISAN?
