Non-Invasive Basal Cell Carcinoma Treatment Yields High Clinical Clearance Rate

A high clinical clearance rate was observed with doxorubicin microneedle array (D-MNA) as a non-invasive way to treat basal cell carcinoma of the skin, according to results from the phase 2 SKNJCT-003 trial (NCT06608238).¹

On day 29 post-treatment, 15 patients receiving 200 ug D-MNA had a clinical clearance rate of 40% and a histological clearance rate of 27%; in the 100 ug arm, 17 patients had a clinical clearance rate of 47% and a histological clearance rate of 24%; and in the placeboa arm, 15 patients had a clinical clearance rate of 33% and a histological clearance rate of 20%.

On day 57 post-treatment, 15 patients in the 200 ug D-MNA arm had a clinical clearance rate of 73% and a histological clearance rate of 40%; in the 100 ug arm with 12 patients, the clinical clearance rate was 42% and the histological clearance rate was 33%, and in the placebo arm with 16 patients, the clinical clearance rate was 38% and the histological clearance rate was 38%.

Additional data, including the full safety analyses and procedural observations, will be completed in Q2 2026.

“We are extremely encouraged by these topline results, which not only validate management’s scientific and investment thesis, but also provide what we consider to be decision-grade evidence of clinical activity, particularly at the 200-microgram dose level,” Raza Bokhari, MD, MBA, executive chairman and chief executive officer of Medicus, said in the press release.¹

Trial Design of Phase 2 SKNJCT-003

The study enrolled 90 patients and randomly assigned patients 1:1:1 to either the placebo group, the 100 ug group, or the 200 ug group. At each time point, 47 patients were assessed on day 29, and 43 patients on day 57. The primary end point was achieving both clinical and histological clearance at a prespecified post-treatment timepoint.

Patients were included in the study if they were male or non-pregnant female 18 years or older; had a clinical diagnosis of a primary, previously untreated, histologically confirmed nodular basal cell carcinoma lesion that was suitable for excision; were willing to refrain from exposure to excessive direct sunlight or ultraviolet while also avoiding tanning beds during the study; and were able to receive the test article treatments, comply with study instructions, and commit to follow-up visits during the duration of the study.²

Patients were excluded from the study if they were pregnant, lactating, or planning to become pregnant; had nevoid basal cell carcinoma on the face, scalp, digits, mucosa, or skin that is scarred; had a history of treated nevoid basal cell carcinoma lesion recurrence; or were immunocompromised based on medical condition.

FDA Decisions for D-MNA

In August 2025, the agent’s developer accepted a Type C meeting with the FDA to discuss D-MNA and to further align on the agent’s clinical pathways.³

In the current press release, the developer noted that these results would support an end of phase 2 meeting with the FDA. However, the company noted there was no assurance this will become approved by the FDA.

SKINJCT-001 trial

Previously, the phase 1 SKINJCT-001 trial (NCT03646188) was conducted to determine the safety and tolerability, as well as the maximum tolerated dose of D-MNA in patients with superficial or nodular basal cell carcinoma.⁴ The study found the 200 ug dose to be optimal.

Complete responses were elicited and noted as the disappearance of basal cell carcinoma histologically at the final excision at the end of the study visit in 6 patients. Of note, all 6 patients had the nodular subtype of basal cell carcinoma.

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. March 5, 2026. Accessed March 6, 2206. https://tinyurl.com/2s3dx6br
2. The Purpose of this study is to evaluate the safety and efficacy of D-MNA in adult patients with nodular basal cell carcinoma. ClinicalTrials.gov. Updated September 9, 2024. Accessed March 6, 2026. https://tinyurl.com/ywz683j5
3. Medicus Pharma Ltd. provides update on doxorubicin containing novel microneedle array (D-MNA) clinical development program for the treatment of basal cell carcinoma (BCC) of the skin and reports second quarter 2025 financial highlights. News release. Medicus Pharma Ltd. August 21, 2025. Accessed March 6, 2026. https://tinyurl.com/ysfusn94
4. Dose escalation trial to evaluate dose limiting toxicity/​maximum tolerated dose of microneedle arrays containing doxorubicin (D-MNA) in basal cell carcinoma (BCC). ClinicalTrials.gov. Updated March 12, 2024. Accessed March 6, 2026. https://tinyurl.com/328jzzvh