Ms. Carolyn Bonner reports

MEDICUS PHARMA PROVIDES UPDATE ON SKNJCT-003 PHASE 2 CLINICAL STUDY FOR THE TREATMENT OF NODULAR BASAL CELL CARCINOMA (BCC)

Medicus Pharma Ltd.'s phase 2 clinical study (SKNJCT-003), which is currently under way in nine clinical sites in United States, has now randomized more than 50 per cent of the 60 patients expected to be enrolled in the study.

The company also announced that it is on track to complete an interim data analysis before the end of Q1 2025 and to submit its findings to the U.S. Food and Drug Administration (FDA) as part of a package seeking a Type C meeting with the FDA in Q2 2025.

The purpose of the Type C meeting is to formally discuss the product development and gain further alignment on the clinical pathway. The company's aim is to gain FDA's consent to fast-track the clinical development program.

Clinical trial design

The clinical study, SKNJCT-003, is designed to be a randomized, double-blind, placebo-controlled (P-MNA), multicentre study enrolling up to 60 subjects presenting with BCC (basal cell carcinoma) of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared with a placebo control. The participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100 micrograms of D-MNA and a high-dose group receiving 200 micrograms of D-MNA.

The high-dose, 200-microgram D-MNA proposed in the study is the maximum dose that was used in the company's phase 1 safety and tolerability study (SKNJCT-001) completed in March, 2021.

SKNJCT-001 met its primary objective of safety and tolerability. The investigational product, D-MNA, was well tolerated across all dose levels in all 13 participants enrolled in the study, with no dose-limiting toxicities (DLTs) or serious adverse events (SAEs). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs (electrocardiograms) and physical examinations. The study also describes the efficacy of the investigational product, D-MNA, with six participants experiencing complete responses. The complete response is defined as the disappearance of BCC histologically in the final excision at the end-of-study visit. The participant profile demonstrating complete responses was diverse, and all participants (six out of six) had nodular subtype of BCC.

About Medicus Pharma Ltd:

Medicus Pharma is a biotechnology/life sciences company focused on accelerating the clinical development programs of novel and disruptive therapeutics assets.

SkinJect Inc., a wholly owned subsidiary of Medicus Pharma, is a development-stage, life sciences company focused on commercializing novel, non-invasive treatment for basal cell skin cancer using patented dissolvable microneedle patch to deliver chemotherapeutic agent to eradicate tumour cells. The company has completed a phase 1 safety and tolerability study (SKNJCT-001) in March, 2021, which met its primary objective of safety and tolerability; the study also describes the efficacy of the investigational product D-MNA, with six participants experiencing complete response on histological examination of the resected lesion. The company submitted a phase 2 IND (investigational new drug) clinical protocol to the FDA in January, 2024, for a randomized, controlled, double-blind, multicentre clinical study (SKNJCT-003) that is expected to randomize up to 60 patients. The study is designed to evaluate the efficacy of two dose levels (100 micrograms and 200 micrograms) of D-MNA compared with placebo (P-MNA) in subjects with nodular BCC. Patient recruitment is currently under way in nine sites across the United States.

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