In July 2019 Hoth entered into a sponsored research agreement with the George Washington University (GW) to explore the potential use of WEG-232 for topical and/or systemic therapy to counter the dermatological related side-effects of Erlotinib therapy in cancer patients. Erlotinib is a drug that is used to combat various cancers and has been known to cause varying degrees of skin rashes, lesions, hair loss and nail changes to patients. These side-effects can impact the patient’s quality of life and even cause treatment interruption, jeopardizing the overall success of the treatment. The research agreement intends to explore whether other chronic conditions that also display dermatitis may benefit from this novel therapeutic approach.

Current Study:

A preclinical study was conducted at the George Washington University overseen by Dr. William B Weglicki, M.D., Professor of Biochemistry and Molecular Medicine and Professor of Medicine at the GW School of Medicine and Health Science. The preclinical study results demonstrated the potential effectiveness of WEG-232, a topical treatment with specific substance P-receptor inhibitor for Erlotinib-induced facial dermatitis and hair loss in cancer patients.

Erlotinib, an EGFR1-tyrosine kinase inhibitor, is an effective anti-tumorigenesis agent, which combats several cancers including lung, colon, head and neck.  Typically, significant and often severe cutaneous toxicities are serious side effects of Erlotinib, limiting its full potential use to prolong patient survival. Previous studies suggest that neurogenic inflammation plays a serious role in causing EGFR-TKI induced off-target toxicity.  This trial was designed to assess if topical application of WEG-232, a specific Substance P-receptor inhibitor, would be protective against erlotinib-induced facial rash and/or hair loss.

The research, which took place at the George Washington University and supported by Hoth, suggests the topical application of WEG-232 could be very effective in suppressing erlotinib induced-facial rash/hair loss with approximate 71% reduction. It concluded that WEG-232 may be used as an effective intervention to prevent EGFR-TKI-induced cutaneous toxicity.

Next Steps:

Further our preclinical work while also preparing for a pre-Investigational New Drug (Pre-IND) meeting request with the U.S. FDA. Please check back for further updates.


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