Medicus Pharma Ltd (MDCX), a biotech/life sciences company, on Wednesday announced the submission of a Phase 2b SKNJCT-005 protocol under an existing investigational new drug (IND) application to the FDA for SkinJect in the treatment lesions associated with Gorlin syndrome.
Shares rose by over 15% on Wednesday, following the announcement.
Gorlin syndrome or Nevoid basal cell carcinoma (NBCC) is a rare genetic disorder associated with a lifetime development of multiple basal cell carcinomas and recurrent skin cancers. The disease effects approximately one in every 30,000 to 60,000 individuals worldwide.
SkinJect is a novel, localised immuno-oncology product developed for treating lesions caused by non-melanoma skin diseases, mainly basal cell carcinoma and Gorlin syndrome.
The proposed open-label, multi-center registrational Phase 2b SKNJCT-005 trial plans to administer SkinJect in a 200 mcg dose to 50 patients. The study may then assess two to four lesions that receive three treatments, with an option for a fourth treatment, by evaluating visual clearance. The primary endpoint will measure the proportion of patients achieving 50% clinical clearance of lesions by week 10.
The Phase 2 SKNJCT-003 trial similarly evaluated doxorubicin containing microneedle arrays (D-MNA) in patients with nodular basal cell carcinoma (nBCC), resulting in 64% clinical clearance, and 55% histological clearance of lesions.
The company is additionally seeking an Orphan drug designation and a Rare Pediatric Disease Priority Review Voucher from the FDA for SkinJect in treating Gorlin syndrome.
MDCX is currently trading at $0.39, up 16.31%.
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