Medicus Pharma has announced the completion of patient enrollment for its phase 2 SKNJCT-003 trial, evaluating the safety and efficacy of SkinJect Doxorubicin Microneedle Array (D-MNA) in the treatment of nodular basal cell carcinoma (BCC) of the skin.
The study is currently underway in nine clinical sites across the US, and has recruited a total of 90 US patients. Medicus expects to release topline study results in early 2026, and to secure an end-of-phase 2 (EOP2) meeting with the US FDA in the first half of 2026.
The study is a randomised, double-blind, placebo-controlled multidose study. The highest dose administered to a patient subgroup (200μg D-MNA) was also the maximum dose administered in Medicus’ phase 1 safety and tolerability study, SKNJCT-001, completed in March 2021.
The SKNJCT-001 trial included 13 participants and met both its primary endpoints of safety and tolerability, with the drug being well-tolerated and no serious adverse events being reported.
Interim results for SKNJCT-003, released in March 2025, demonstrated more than 60% clinical clearance. Additionally, in October 2025, Medicus treated the first patient in its SKNJCT-004 study, which is ongoing in the United Arab Emirates (UAE). The study is expected to randomise 36 patients across six UAE sites, with Cleveland Clinic Abu Dhabi (CCAD) as the principal investigator.
In November 2025, Medicus received full approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA) and Wales Research Ethics Committee (WREC) to expand SKNJCT-003.
Raza Bokhari, executive chairman and CEO of Medicus, said: “Successfully completing the US enrolment of 90 patients for SKNJCT-003 brings us one more step closer to bringing to market a non-invasive, patient-friendly, cost-effective, localised immune therapy to treat basal cell carcinoma of the skin, which we believe represents ~$2bn in potential market opportunity.”
Related news from Medicus includes the announcement of a partnership with the Gorlin Syndrome Alliance (GSA) to advance compassionate access to SkinJect treatment for patients suffering from Gorlin Syndrome, also known as nevoid basal cell carcinoma syndrome.