Medicus Pharma has announced plans to extend its SKNJCT-003 Phase II clinical study for the treatment of nodular basal cell carcinoma (BCC). 

The Institutional Review Board (IRB) has approved the increase in the number of patients from 60 to 90. 

The trial will expand into additional sites in United States, as well as two clinical trial sites in Europe. 

The company has also submitted a clinical design (SKNJCT-004) to United Arab Emirates (UAE) Department of Health (DOH) and hopes to randomise 36 patients in four sites in UAE. 

“Increasing the number of participants in the study and expanding the clinical trial sites in Europe is very time appropriate,” stated Dr Raza Bokhari, Executive Chairman & CEO. “With our study design awaiting approval by the Department of Health in Abu Dhabi, and exploring collaboration in the Asia-pacific region, we are making promising progress in securing global validation of our novel, non-invasive treatment for BCC.” 

Medicus states that it is on track to submit the package seeking a Type C meeting with the US Food and Drug Administration (FDA) before the end of Q2 2025. 

Earlier in March 2025, the company’s interim analysis showed that clinical study SKNJCT-003 is trending positively with a proportion of subjects with complete clinical clearance of more than 60%.  

The analysis also showed the investigational product D-MNA was well tolerated for both dose levels, with no dose limiting toxicities (DLTs), or serious adverse events (SAEs).  

In addition, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs, and physical examination. The findings of the interim analysis are preliminary and may or may not correlate with the findings of the study once completed.

Diana Spencer, Senior Digital Content Editor, DDW