Medicus gets UAE OK for phase 2 trial of SKNJCT-004 for skin cancer

Medicus gets UAE OK for phase 2 trial of SKNJCT-004 for skin cancer

By, Admin 26 May 2025

Medicus Pharma Ltd, a biotech/life sciences company focused on accelerating clinical development of novel therapeutics, announced it has received "study may proceed" approval from the UAE Department of Health to commence a Phase 2 clinical study to non-invasively treat basal cell carcinoma (BCC) of the skin.

  • Study Name: SKNJCT-004
  • Design: Randomized, double-blind, placebo-controlled, multi-center
  • Target Enrollment: 36 patients
  • Study Locations:
    • Cleveland Clinic Abu Dhabi
    • Sheikh Shakbout Medical City
    • Burjeel Medical City
    • American Hospital of Dubai

Trial Coordination

  • Coordinated by Insights Research Organization and Solutions (IROS), a UAE-based contract research organization.
  • IROS is a M42 portfolio company.

Study Design: SKNJCT-004

The study will evaluate the efficacy of two dose levels of D-MNA versus a placebo control.
Participants (36) will be randomized 1:1:1 into the following groups:

  • Placebo group: Receiving P-MNA
  • Low-dose group: Receiving 100µg of D-MNA
  • High-dose group: Receiving 200µg of D-MNA

The 200µg D-MNA dose proposed is the maximum dose used in the SKNJCT-001 Phase 1 study, completed in March 2021.

SKNJCT-001: Completed Phase 1 Study Overview

Primary Objective Met: Safety and tolerability

  • Participants: 13
  • Findings:
    • D-MNA was well tolerated across all dose levels
    • No dose-limiting toxicities (DLTs)
    • No serious adverse events (SAEs)
    • No systemic effects or significant lab/vitals/ECG abnormalities
  • Efficacy Observed:
    • 6 participants had complete responses
    • Complete response = histological disappearance of BCC
    • All 6 had the nodular subtype of basal cell carcinoma

SKNJCT-003: Ongoing Phase 2 Study in the United States

  • Sites: 9 clinical sites across the US
  • Started: August 2024
  • Interim Analysis (March 2025):
    • Over 60% clinical clearance
    • Conducted after >50% of initial 60 patients were randomized
    • Preliminary: May or may not correlate with final outcomes
  • April 2025 Updates:
    • Participant count increased to 90
    • Clinical trial expanding to Europe

Corporate Expansion & Strategic Acquisition

April 2025: Medicus Pharma entered a binding letter of intent to acquire Antev Ltd, a UK-based, late-clinical-stage biotech firm.

  • Lead Candidate: Teverelix – a next-generation GnRH antagonist
  • Target Indications:
    • Cardiovascular high-risk prostate cancer patients
    • Patients with first acute urinary retention (AURr) episodes due to enlarged prostate

Acquisition Status:

  • Subject to:
    • Satisfactory due diligence
    • Negotiation of definitive agreements
    • Corporate, regulatory, and third-party approvals
    • Fulfillment of customary closing conditions

About SkinJect Inc.

SkinJect Inc., a wholly owned subsidiary of Medicus Pharma Ltd, is:

  • A development-stage life sciences company
  • Commercializing a novel, non-invasive BCC skin cancer treatment
  • Uses a patented dissolvable microneedle patch to deliver a chemotherapeutic agent that eradicates tumor cells

Clinical Programs:

  • Phase 1 (SKNJCT-001): Completed March 2021 – Met safety and tolerability goals; 6 patients showed complete response
  • Phase 2 (SKNJCT-003): Ongoing in the US and Europe
  • Phase 2 (SKNJCT-004): Newly initiated in UAE

April 2025: Also announced binding LOI to acquire Antev Ltd, developing Teverelix for prostate-related conditions

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