Dr. Raza Bokhari reports

MEDICUS PHARMA LTD. ANNOUNCES COLLABORATION AGREEMENT TO EXPAND PHASE 2 CLINICAL STUDY IN ASIA PACIFIC REGION

Medicus Pharma Ltd. has signed an agreement with Swanielle Inc. to explore expansion of the phase 2 clinical study for treatment of basal cell carcinoma in the Asia Pacific region.

Under the agreement, Swanielle, a bespoke health care consulting firm, will help identify a pharmaceutical/biotech company or companies in Southeast Asia to partner with Medicus to expand the phase 2 clinical study in the Asia Pacific region.

The phase 2 clinical study (SKNJCT-003) is currently under way in nine clinical sites in United States and has already randomized more than 25 per cent of the 60 patients expected to be enrolled in the study. Medicus is planning to initiate an interim data analysis in first quarter 2025 and submit its findings to the U.S. Food and Drug Administration as a part of a package seeking a Type C meeting with the FDA in second quarter 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 fast-track the clinical development program and convert the SKNJCT-003 exploratory clinical trial into a pivotal clinical trial.

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 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 to 1 to 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 or serious adverse events. Furthermore, there were no systemic effects or clinically significant abnormal findings in laboratory limits, 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 (six out of six) had nodular subtype of BCC.

"We are delighted with the progress we have made in advancing the clinical development program of our novel, non-invasive treatment to cure the most common cancer in the world," stated Dr. Raza Bokhari, executive chairman and chief executive officer. "The collaboration with Swanielle to explore expansion of our clinical study to treat BCC in Southeast Asia will help us gather useful efficacy and safety data, which will strengthen the analysis of the pivotal trial that we plan to commence in not-so-distant future."

The agreement with Swanielle has an initial term of one year, commencing on Dec. 1, 2024. Under the agreement, Swanielle will receive a retainer fee of $22,500. In addition to the retainer, there is a variable rate success fee of 1 per cent to 5 per cent dependent on the execution of a definitive agreement between company and a qualifying partner.

Swanielle does not have any interest, directly or indirectly, in the company or its securities, or any right or intent to acquire such an interest.

About Medicus Pharma Ltd.

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

SkinJect Inc., a wholly owned subsidiary of Medicus, is a development-stage, life science 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 of 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 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 doses of two-dose levels (100 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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