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
