Medicus Pharma (NASDAQ:MDCX) has announced the submission of its Phase 2 clinical study design, evaluating its non-invasive therapy targeting basal cell carcinoma (BCC) of the skin, to the United Arab Emirates (UAE) Department of Health.
The study, SKNJCT-004, is set to enroll 36 participants across four leading medical institutions in the UAE: the Cleveland Clinic Abu Dhabi, Sheikh Shakbout Medical City, Burjeel Medical City, and American Hospital of Dubai.
The study is being coordinated by Insights Research Organization and Solutions, a UAE-based contract research organization.
SKNJCT-004 is a randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy of two dose levels of D-MNA compared to a placebo.
Participants will be assigned to one of three groups: a placebo group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, or a high-dose group receiving 200μg of D-MNA.
The high-dose level mirrors the maximum dosage used in Medicus Pharma’s Phase 1 safety and tolerability study (SKNJCT-001), completed in March 2021.
That study demonstrated that D-MNA was well tolerated at all dose levels, with no dose-limiting toxicities or serious adverse events. Additionally, six participants showed complete histological clearance of BCC, particularly among those with the nodular subtype.
'Substantial progress'
“We are making substantial progress in expanding the clinical development program of our novel non-invasive treatment to cure the most common cancer in the world, beyond the shores of United States,” Medicus Pharma CEO Dr Raza Bokhari said.
Bokhari highlighted that the UAE is quickly establishing itself as a key center for pharmaceutical R&D, fueled by strategic investments, public-private collaborations, and a strong focus on innovation.
“A clinical study in the Middle East will help us gather useful efficacy and safety data,” the CEO said.
“It will also help us strengthen our clinical development program, as we aspire to bring to market not only the first-in-class, but also the best-in-class, novel non-invasive treatment regimen for BCC.”
Phase 2 US study
In addition to the UAE study, Medicus Pharma is conducting a Phase 2 trial (SKNJCT-003) in the United States across nine clinical sites, with a target enrollment of 60 patients.
More than half of the participants have already been randomized, and the company anticipates completing an interim data analysis by the end of the first quarter.
These findings will be submitted to the US Food and Drug Administration (FDA) as part of a request for a Type C meeting in Q2, aimed at aligning on the clinical pathway and potentially accelerating the development process.
Shares of Medicus Pharma were up 6.7% on Thursday following the news