Medicus Pharma Receives Regulatory Approval for Phase 2 Trial of Non-Invasive BCC Treatment

Strategic Insights -

Medicus Pharma has secured regulatory clearance from the UAE Department of Health to conduct a Phase 2 clinical trial evaluating its D-MNA therapy for basal cell carcinoma (BCC) of the skin. The trial, SKNJCT-004, will involve 36 patients across four medical centers in the UAE and compare the efficacy of two doses of D-MNA against a placebo.

Key Takeaways:

  • The randomized, double-blind, placebo-controlled trial will enroll up to 36 patients with BCC of the skin across four medical centers in the UAE.
  • The trial will assess the efficacy of two doses of Medicus' topical formulation, D-MNA, against a placebo in treating BCC lesions.
  • The 200ð­g dose of D-MNA was previously tested in a Phase 1 trial (SKNJCT-001), which concluded in March 2021 and met its safety and tolerability goals.
  • The Phase 1 trial reported no serious adverse events or dose-limiting toxicities and achieved complete histological clearance of BCC lesions in six out of 13 participants.
  • Medicus is concurrently conducting a Phase 2 trial (SKNJCT-003) in the US, which began enrolling patients in August 2024 and has shown more than 60% clinical clearance among patients treated, based on data from over half of the targeted 60 enrollees.
  • The company has announced the expansion of the US trial to include 90 participants and additional sites in Europe.

Statistics:

  • 36 patients will be enrolled in the Phase 2 trial, SKNJCT-004, in the UAE.
  • 200ð­g dose of D-MNA was previously tested in the Phase 1 trial (SKNJCT-001), which concluded in March 2021.
  • 83% (6 out of 13) of patients in the Phase 1 trial achieved complete histological clearance of BCC lesions.
  • More than 60% of patients in the US-based Phase 2 trial (SKNJCT-003) have shown clinical clearance based on data from over half of the targeted 60 enrollees.
  • The US-based Phase 2 trial has been expanded to include 90 participants and additional sites in Europe.

Sources:

  • UAE Department of Health
  • Medicus Pharma (NASDAQ:MDCX)
  • "(...) SKNJCT-004 will begin a Phase 2 clinical trial (...) evaluating its non-invasive therapy for basal cell carcinoma (BCC) of the skin (...) enrolling up to 36 patients (...) across four medical centers in the UAE."