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Thursday, December 29, 2022

FDA Signs Off Hoth Therapeutics' Trial Application For HT-001 For Skin Cancers

 

  • The FDA has accepted the Investigational New Drug (IND) application for Hoth Therapeutics Inc's  HT-001 therapeutic for rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy. 
  • EGFR inhibitors are critical therapeutic agents for the treatment of non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer, squamous-cell carcinoma of the head and neck, and breast cancer.
  • "With no specific treatment currently approved for the treatment of skin toxicities associated with EGFRi therapies, this trial brings us one step closer to a new treatment option for underserved cancer patients," said Robb Knie, CEO of Hoth Therapeutics. 
  • The company expects to begin the Phase 2a trial in Q1 of 2023.
  • In October, Hoth Therapeutics announced Phase 1b trial data for BioLexa in adult patients with mild-to-moderate atopic dermatitis showing an improvement in disease severity.

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