Dr. Raza Bokhari reports

MEDICUS PHARMA LTD. RECEIVES FDA COMMENTS ON PHASE 2 CLINICAL PROTOCOL TO NON-INVASIVELY TREAT BASAL CELL CARCINOMA OF THE SKIN

Medicus Pharma Ltd. has received comments from the U.S. Food and Drug Administration (FDA).

The clinical non-hold comments from the FDA consider the results of the study exploratory and request the company to provide data from clinical studies (SKNJCT-001) to support the dose of 100 micrograms and 200 micrograms of microarray needles containing doxorubicin (D-MNA). FDA has also requested the company to provide an updated investigator brochure that includes information from the clinical studies SKNJCT-001 and SKNJCT-002; and, specifically, includes data regarding any adverse events/dose-limiting toxicities at each dose level.

Earlier this year, the company had submitted to the FDA for comments a phase 2 investigational new drug (IND) clinical protocol (SKNJCT-003) to non-invasively treat basal cell carcinoma (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 placebo in patients with nodular BCC. 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 Skinject Inc.'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 found to be safe and well tolerated across all dose levels in all 13 participants enrolled in the study, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs) or adverse events (AEs). 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.

"We are immensely encouraged by the feedback from the FDA," stated Dr. Raza Bokhari, executive chairman and chief executive officer. "The clinical non-hold comments by the FDA bring us one step closer to delivering a game-changing, novel, non-invasive alternative to treat basal cell carcinoma (BCC) of the skin."

The company intends to make a full submission to the FDA in Q2 2024 and shall provide the information requested by the FDA as well as include CMC (chemistry, manufacturing and controls) stability data.

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, 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.

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