Doxorubicin Microneedle Array Shows Positive Response in Skin Cancer Subtype

Independent clinical validation of the phase 2 SkinJect dataset, assessing patients with nodular basal cell carcinoma, was found the be clinically meaningful, with results supporting further development and regulatory engagement, according to a press release from Medicus Pharma.¹

The SkinJect dataset was assessed in the phase 2 SKNJCT-003 trial (NCT06608238), which looked at microneedle-mediated delivery of doxorubicin vs biologically active device-only control for patients with nodular basal cell carcinoma.

SkinJect Independent Clinical Validation Findings

In the 200µg cohort at day 57, findings included approximately and 80% overall response rate, a 73% clinical clearance rate, a 40% histological clearance rate, and demonstrated continued biological activity. These findings have allowed for the drug’s developer to move forward with the 200µg dose as the lead regimen.

The press release also highlighted that SkinJect could serve as a non-surgical alternative option, for select patient groups. This may include patients who have limited access to Mohs surgery, those who would like less invasive treatment options, or those with high lesion burden.

“The clear separation between active drug and device-only control demonstrates a clinically meaningful therapeutic effect on top of a biologically active platform,” Babar Rao, MD, FAAD, professor of Dermatology and Pathology and director of Clinical Research at Rutgers Robert Wood Johnson Medical School, and principal investigator of the SKNJCT-003 trial, said in the press release.¹ “Approximately 3 out of 4 treated lesions may achieve visual tumor clearance, potentially allowing many patients to avoid immediate surgical intervention.”

Comparing the 200µg and 100µg Doses in the SKNJCT-003 Trial

In early March 2026, results regarding the clinical clearance rate were announced.² At day 29, patients in the 200µg cohort had a clinical clearance rate of 40%, and a histological clearance rate of 27%. For those in the 100µg cohort, the rates were 47% and 24%, respectively. For those receiving placebo, the rates were 33% and 20%.

In the SKNJCT-003 trial, a total of 90 patients were enrolled and randomly assigned 1:1:1 to the 200µg cohort, 100µg cohort, or the placebo cohort. On day 29, 47 patients were assessed and on day 57, 43 patients were assessed.

Patients were included in the trial if they were males or non-pregnant females who were 18 years or older; had a diagnosis of a primary, previously untreated, histologically confirmednodular basal cell carcinoma lesion suitable for excision; able and willing to refrain from direct sunlight or ultraviolet light; and were able to receive test article treatments, follow instructions, and commit to the follow-up visits.

Patients were excluded if they were pregnant, lactating, or planning to become pregnant; diagnosed with nevoid basal cell carcinoma on their face, scalp, digits, mucosa, or had scarred skin; had a history of nevoid basal cell carcinoma with lesion recurrence; and were immunocompromised from other medical conditions.

FDA Type C Meeting

A Type C meeting was held with the FDA to discuss the doxorubicin microneedle array for patients with superficial or nodular basal cell carcinoma.³ The meeting was accepted, and would allow the regulatory authorities and the drug’s developer meet to discuss the doxorubicin microneedle array clinical pathway.

References

1. Medicus Pharma reports KOL validation of SkinJect phase 2 data of 80% overall response rate. News release. Medicus Pharma. March 30, 2026. Accessed March 31, 2026. https://tinyurl.com/3rfh79v9
2. 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 31, 2026. https://tinyurl.com/2s3dx6br
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. August 21, 2025. Accessed March 31, 2026. https://tinyurl.com/ysfusn94