On March 30, 2026 Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company"), a biotech/life sciences company focused on advancing the clinical development programs of novel and potentially disruptive therapeutics assets, reported independent clinical validation of its Phase 2 SkinJect dataset from Dr. Babar Rao, principal investigator of the SKNJCT-003 study and a globally recognized dermatology key opinion leader.
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Dr. Rao’s independent assessment reinforces the Company’s view that the dataset is clinically meaningful, decision-grade, and supportive of continued development and regulatory engagement.
Dr. Rao, speaking in his capacity as principal investigator during the Company’s business update call, stated: "In my view as principal investigator, the dataset is clinically meaningful, supports continued development, and justifies regulatory engagement and further trials."
Independent KOL Validation of Phase 2 Results
The SKNJCT-003 study is a randomized, double-blind, three-arm Phase 2 trial evaluating microneedle-mediated delivery of doxorubicin compared with a biologically active device-only control in patients with nodular basal cell carcinoma (BCC).
Dr. Rao described that the study design provides a rigorous clinical framework, enabling:
Isolation of the incremental therapeutic contribution of doxorubicin
Evaluation of both clinical (visual) and histological clearance endpoints
Interpretation of outcomes in the context of a biologically active microneedle platform
"The clear separation between active drug and device-only control demonstrates a clinically meaningful therapeutic effect on top of a biologically active platform," Dr. Rao noted.
The 200µg cohort at Day 57 demonstrated the highest observed activity in the study, including:
~80% overall response rate
73% clinical clearance
40% histological clearance
Evidence of continued biological activity over time
These findings support the Company’s selection of the 200µg dose as the lead regimen for further development.
Dr. Rao highlighted the real-world clinical implications of the dataset, particularly the importance of clinical (visual) clearance:
"Approximately three out of four treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention."
In clinical practice, lesions achieving visual clearance may be monitored or treated with less invasive approaches, suggesting SkinJect could serve as a non-surgical treatment alternative in appropriate patients.
This may be particularly impactful in:
Patients with limited access to Mohs surgery
Patients seeking less invasive treatment options
Individuals with high lesion burden, including those with Gorlin Syndrome
Dr. Babar Rao is a globally recognized dermatologist, dermatopathologist, Mohs surgeon, and clinical investigator with extensive experience in skin oncology and dermatologic research.
He currently serves as Professor of Dermatology and Pathology and Director of Clinical Research at Rutgers Robert Wood Johnson Medical School. He also holds academic appointments as Clinical Associate Professor of Dermatology at Weill Cornell Medical College and Adjunct Professor of Dermatology at California Health Sciences University.
Dr. Rao is board certified in dermatology and is a Fellow of the American Academy of Dermatology. He completed his dermatology residency and chief residency at Cornell University Medical Center, followed by advanced training at leading institutions including New York University Medical Center, Boston University School of Medicine, UT Southwestern Medical Center, and St. John’s Institute of Dermatology at the University of London.
He has authored more than 200 peer-reviewed scientific publications and multiple academic book chapters and has served as principal investigator in numerous clinical trials evaluating novel therapies for skin cancer and other dermatologic conditions.
Dr. Rao has served as principal investigator across multiple dermatology clinical programs evaluating emerging therapeutic modalities in skin cancer.
(Press release, Skinject, MAR 30, 2026, View Source [SID1234664044])