D-MNA Hits 55% Histological Clearance in Nodular BCC at Day 57

A pre-specified expanded analysis from the phase 2 SKNJCT-003 trial evaluating a doxorubicin microneedle array (D-MNA) for nodular basal cell carcinoma has demonstrated a progressive, dose-dependent response, with the strongest efficacy signal emerging at day 57 in the 200µg cohort.¹

The findings, reported by Medicus Pharma Ltd, build on previously disclosed topline results from the 90-patient randomized dataset and offer a more granular look at the drug's histological and clinical activity following central pathology reconciliation.²

Study Design and Population Refinement

SKNJCT-003 (NCT06608238) was a randomized, double-blind, 3-arm phase 2 study enrolling patients with nodular BCC at multiple centers. Participants were randomized 1:1:1 to device-only control (P-MNA), low-dose D-MNA (100µg), or high-dose D-MNA (200µg). Of the 90 enrolled patients, central pathology reconciliation identified 69 who met the intended nodular BCC inclusion criteria; the remaining 21 were classified as superficial or mixed subtype lesions. The expanded efficacy analysis is drawn from this 69-patient refined population.

Efficacy Results

At day 29, clinical and histological clearance rates were broadly comparable across arms. The device-only group (n=12) achieved 42% clinical clearance and 25% histological clearance (complete response, CR). The 100µg cohort (n=12) matched those figures. The 200µg arm (n=11) showed 46% clinical clearance and 27% histological CR—modest separation at that early timepoint.

The more pronounced differences emerged by day 57. In the device-only arm (n=14), clinical clearance fell to 29% and histological CR held at 29%. In the 100µg group (n=9), clinical clearance reached 44% with 33% histological CR. The 200µg cohort demonstrated the strongest response: 64% clinical clearance and 55% histological CR.

The device-only arm's early activity—consistent with microneedle-induced local immune stimulation—did not deepen over time, while the 200µg cohort showed continued improvement between day 29 and day 57, a pattern the company characterizes as consistent with drug-driven therapeutic effect rather than a mechanical response alone.

Safety

D-MNA continued to show a favorable tolerability profile across the study. No drug-related serious adverse events were reported, and no evidence of systemic doxorubicin toxicity was observed. Treatment-site reactions were predominantly mild and localized, consistent with findings from the earlier phase 1 SKNJCT-001 study conducted in March 2021.³

Investigator Perspective

Babar K. Rao, MD, FAAD, principal investigator of SKNJCT-003 and professor of dermatology and pathology at Rutgers Robert Wood Johnson Medical School, reviewed the expanded dataset and noted the alignment across visual, histologic, and central pathology findings.

Rao noted that the consistency between visual, histologic, and central pathology findings is highly encouraging and provides growing confidence that the therapy is producing meaningful biologic anti-tumor effects. He also highlighted the speed of observed response, noting that clinically meaningful anti-tumor activity was detected within weeks—a potential differentiator from non-surgical therapies that typically require longer treatment courses.

Regulatory and Development Context

Medicus characterizes the expanded dataset as supportive of end-of-phase 2 discussions with the FDA. The company views the 200µg regimen as the lead dose and notes that the refined patient population and histologic data may inform subsequent study design, including lesion selection criteria, dose regimen, treatment-to-excision interval, and endpoint strategy.

“We are encouraged by these additional findings in the expanded analysis, which we believe meaningfully strengthens the clinical and regulatory foundation of the SKNJCT-003 Program” said Raza Bokhari, MD, MBA, chairman and CEO of Medicus, in a news release. “We are confident that this dataset moves us from proof-of-concept to a clear registrational path, and we believe Skinject has the potential to fundamentally change the current approach of treating patients with BCC, addressing a major unmet medical need.”

Clinical Takeaway

For clinicians managing nodular BCC, D-MNA represents an investigational intralesional approach that, if validated in registration-enabling studies, could offer a non-surgical or surgery-deferring option for appropriate patients. The data suggest that the 200µg dose produces meaningful, progressive tumor clearance within a clinically practical timeframe, though the relatively small per-arm sample sizes and the study's pre-registration status warrant cautious interpretation. The reproducibility of the safety profile across phase 1 and phase 2 will be an important consideration as the program moves forward.

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References

1. Medicus Pharma reports positive phase 2 SKNJCT-003 topline data observing 73% clinical clearance and 40% histological clearance (CR) at day 57 in 200μg cohort. News release. Medicus Pharma. Published March 5, 2026. Accessed May 6, 2026. https://medicuspharma.com/medicus-pharma-reports-positive-phase-2-sknjct-003-topline-data-observing-73-clinical-clearance-and-40-histological-clearance-cr-at-day-57-in-200g-cohort/
2. Medicus Pharma announces results from pre-specified expanded phase 2 SKNJCT-003 data analysis demonstrating positive dose-response. News release. Medicus Pharma. Published May 6, 2026. Accessed May 6, 2026. https://www.globenewswire.com/news-release/2026/05/06/3288692/0/en/medicus-pharma-announces-results-from-pre-specified-expanded-phase-2-sknjct-003-data-analysis-demonstrating-positive-dose-response.html
3. Medicus Pharma Ltd. publishes phase 1 clinical study report demonstrating safety & tolerability in all participants with basal cell carcinoma. News release. Medicus Pharma. Published February 15, 2024. Accessed May 6, 2026. https://medicuspharma.com/medicus-pharma-ltd-publishes-phase-1-clinical-study-report-demonstrating-safety-tolerability-in-all-participants-with-basal-cell-carcinoma/