Ms. Carolyn Bonner reports

MEDICUS PHARMA LTD. SUBMITS UPDATED PHASE 2 CLINICAL PROTOCOL TO NON-INVASIVELY TREAT BASAL CELL CARCINOMA OF THE SKIN

Medicus Pharma Ltd. has submitted an updated and complete phase 2 investigational new drug (IND) clinical protocol (SKNJCT-003) to the United States Food and Drug Administration (FDA) to treat non-invasively treat basal cell carcinoma (BCC) of the skin using micro-needle arrays containing doxorubicin (D-MNA), developed by its wholly owned portfolio company, Skinject Inc.

The submission included updates to the clinical protocol, supporting chemistry, manufacturing and controls (CMC), stability and sterility information, as well as responses to the clinical non-hold comments received from the FDA on March 21, 2024.

The company provided the safety data requested by the FDA from the phase 1 safety and tolerability study completed in March, 2021 (SKNJCT-001), to support the doses of 100 mug and 200 mug of D-MNA.

The company also provided an updated investigator brochure featuring safety information from the SKNJCT-001 and SKNJCT-002 clinical trials.

Earlier this year, the company had submitted a phase 2 IND clinical protocol (SKNJCT-003) to the FDA to non-invasively treat BCC of the skin using microarray needles containing doxorubicin (D-MNA). The clinical study, SKNJCT-003, is designed to be a randomized, double-blinded, placebo-controlled (P-MNA), multicentre study enrolling up to 60 subjects presenting with nodular type BCC of the skin. The study will evaluate the efficacy of two dose levels of D-MNA compared with. 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 (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 participants profile demonstrating complete responses was diverse and all participants (six/six) had nodular subtype of BCC.

The updated phase 2 clinical protocol (SKNJCT-003) includes the addition of artificial intelligence (AI) and confocal microscopy as supplementary endpoints at one of the clinical sites.

"This phase 2 clinical protocol, in its final form, is a comprehensive design, well positioned to get the nod from the FDA to commence randomizing participants hopefully before the end of this quarter," stated Dr. Raza Bokhari, executive chairman and chief executive officer. "We are very excited to incorporate artificial intelligence (AI) powered software and confocal microscopy as supplemental endpoints in one of the clinical site to improve the assessment accuracy of the clinical program and hopefully also eliminate any invasive intervention even at the diagnostic stage, making our treatment regimen completely non-invasive from start to finish."

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.