Medicus Pharma Ltd. (Medicus Pharma (MDCX)) released expanded data from its Phase 2 SKNJCT-003 study on Wednesday, and the numbers are telling a pretty clear story: when it comes to treating nodular basal cell carcinoma with its Doxorubicin Microneedle Array (D-MNA, or SkinJect), higher doses seem to work better.

The company reported a dose-response relationship across the three groups in the study: a device-only control, a 100µg dose, and a 200µg dose. A total of 90 patients were enrolled, split evenly among the groups. The pre-specified analysis digs deeper into the topline results announced back in March, offering biological, histological, and safety insights that reinforce what earlier Phase 1 and interim Phase 2 data had suggested.

The 200µg dose cohort was the standout. It achieved a 73% clinical clearance rate and a 40% histological clearance rate at Day 57. But here's the interesting part: clearance rates actually improved between Day 29 and Day 57, which suggests the drug keeps working even after the initial treatment period. That's the kind of continued biological activity you want to see.

The company also refined the dataset to 69 patients, which sharpened the efficacy signals and made the results easier to interpret for regulatory purposes. And importantly, the higher dose showed a stronger separation from the control arm, supporting the idea that the therapeutic effect is drug-driven, not just a result of the device itself.

Safety Profile and Treatment Implications

On the safety front, D-MNA maintained a favorable profile. No drug-related serious adverse events or systemic toxicity were observed, and most reactions were mild and localized. That's a big deal for a treatment that's being developed as a non-surgical option for nodular BCC, a common form of skin cancer that's typically treated with surgery.

The data also suggest that some lesions could potentially avoid immediate surgery, pointing toward a shift to less invasive treatment approaches. That's a practical therapeutic window that could change how doctors and patients think about managing this condition.

Regulatory Path and Next Steps

Medicus 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, the company is positioning the program for End-of-Phase 2 engagement with the U.S. Food and Drug Administration (FDA).

In April, Medicus submitted an Orphan Drug Designation (ODD) application to the FDA for BCC in patients with Gorlin Syndrome, a rare genetic disorder that causes multiple, recurrent skin cancers. That's a strategic move that could provide additional regulatory benefits if approved.

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.