Mr. Carolyn Bonner reports

MEDICUS PHARMA LTD. ANNOUNCES FIRST PATIENT RANDOMIZED IN PHASE 2 TRIAL OF SKNJCT-003 FOR THE TREATMENT OF NODULAR BASAL CELL CARCINOMA IN ADULTS

Medicus Pharma Ltd. has enrolled the first patient in its phase 2 clinical trial, SKNJCT-003, for the treatment of nodular basal cell carcinoma (nBCC).

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 nBCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared to 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 mug of D-MNA and a high-dose group receiving 200 mug of D-MNA.

The high-dose, 200 mug D-MNA, proposed in the study is the maximum dose that was used in SkinJect'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 (SAE). Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory parameters, vital signs, ECGs 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 participants profile demonstrating complete responses was diverse and all participants (6/6) had nodular subtype of BCC.

"Randomizing the first participant is an important milestone for the company," stated Dr. Raza Bokhari, executive chairman and chief executive officer. "Our artificial intelligence (AI) powered phase 2 study protocol, supported by Confocal microscopy, is designed to position the company to gain regulatory alignment with the FDA and fast-track the clinical development program. BCC is the most common cancer across the globe with estimated five million cases diagnosed in the U.S. each year. There is no effective non-invasive treatment regimen available to treat BCC; we aspire to deliver both first in class and best in class novel therapeutic alternative to fulfill this unmet medical need."

About Medicus Pharma Ltd.

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

We seek Safe Harbor.