Medicus Pharma Ltd. (NASDAQ:MDCX) on Wednesday reported expanded Phase 2 SKNJCT-003 study data showing a clear dose-response relationship for its Doxorubicin Microneedle Array (D-MNA or SkinJect) for nodular basal cell carcinoma (BCC).

The company said the pre-specified analysis builds on previously disclosed topline results, offering deeper biological, histological, and safety insights.

The findings reinforce consistency across earlier studies, including Phase 1 and interim Phase 2 data.

A total of 90 patients were enrolled and split evenly across three groups: device-only, 100µg dose, and 200µg dose.

The topline results, announced in March, from the SKNJCT-003 Phase 2 study indicated that the 200µg dose cohort achieved a 73% clinical clearance rate and a 40% histological clearance rate.

Higher Dose Shows Stronger Efficacy Signal

The expanded dataset highlighted a progressive improvement tied to dose levels, with the 200µg cohort delivering the strongest results at Day 57.

Clearance rates improved between Day 29 and Day 57, suggesting continued biological activity.

The refined 69-patient dataset further sharpened efficacy signals and improved interpretability for regulatory alignment.

The company noted that the higher dose demonstrated stronger separation from the control arm, supporting a drug-driven therapeutic effect rather than device-related activity.

Safety Profile And Treatment Implications

D-MNA maintained a favorable safety profile, with no drug-related serious adverse events or systemic toxicity observed. Most reactions were mild and localized.

SkinJect is being developed as a potential non-surgical treatment option for nodular BCC, a common form of skin cancer currently treated primarily with surgical intervention.

The data also suggest that some lesions could potentially avoid immediate surgery, indicating a shift toward less invasive treatment approaches within a practical therapeutic window.

Regulatory Path And Next Steps

The company believes the dataset supports future registration-focused discussions, including optimization of patient selection, dosing, and treatment timelines.

With consistent results across studies and a clear dose-response signal, Medicus is positioning the program for End-of-Phase 2 engagement with the U.S. Food and Drug Administration (FDA).

In April, the company submitted an Orphan Drug Designation (ODD) application to the FDA for BCC in patients with Gorlin Syndrome, a rare genetic disorder characterized by the development of multiple, recurrent skin cancers.

MDCX Price Action: Medicus Pharma shares were up 1.02% at $0.27 during premarket trading on Wednesday. The stock is trading near its 52-week low of $0.25, according to Benzinga Pro data.

Image Credit: AdobeStock Image