Hoth Therapeutics Inc., a patient-focused biopharmaceutical company, 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 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 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.