Hoth Therapeutics Inc. (NASDAQ: HOTH) has signed a manufacturing agreement with NUVISAN to produce clinical batches of HT-001 topical drug candidates for the upcoming CLEER-001 clinical study for cancer patients.
NUVISAN was chosen as Hoth’s CDMO/CRO for HT-001
NUVISAN is an EU CDMO/CRO with topical production capabilities located in Sophia-Antipolis, France. HT-001 is a new topical medication in clinical trials to treat cutaneous side effects linked to cancer treatments that inhibit the epidermal growth factor receptor (EGFR).
The company’s chosen VDMO/CRO service provider, NUVISAN group, provided integrated solutions across the drug research value chain beginning from selection through proof of concept in patients and also all related services such as GMP synthesis, chemistry, DMPK, formulation development, clinical trial supplies, bioanalytics, analytics and first phase clinical trials. In addition, NUVISAN France focuses on breakthrough topical formulations development and GMP production, thanks to its dermatological background.
Hoth CEO Robb Knie said, “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. 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.”
CLEER-001 study evaluating safety and efficacy if HT-001
NUVISAN France Managing Director, Pierre Diebolt, said, “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.”
The CLEER-001 clinical study is a Phase 2a dose-ranging trial that will look at the tolerability, safety, and efficacy of topical HT-001 for skin toxicity caused by EGFR inhibitors treatment. The trial will take place at 14 clinical locations across the United States. Hoth’s portfolio focuses on enhancing the quality of life for people with skin toxicities linked with cancer therapy, atopic dermatitis, chronic wounds, asthma, acne, psoriasis, and mast cell-related malignancies.
