Medicus Pharma's SKNJCT-004 Trial Begins Enrolling Participants in UAE
PorAinvest
lunes, 15 de septiembre de 2025, 10:28 am ET2 min de lectura
MDCX--
The SKNJCT-004 study is designed as a randomized, double-blind, placebo-controlled, multi-center trial, enrolling up to 36 subjects presenting with BCC of the skin. Participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose, 200μg D-MNA, is the maximum dose used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021 [1].
Medicus Pharma's broader clinical program targeting BCC continues to advance. The company's SKNJCT-003 Phase 2 clinical study is currently underway in nine clinical sites across the United States and Europe. As of August 2025, SKNJCT-003 has randomized more than 75% of the 90 participants expected to be randomized in the study [1].
In addition to its clinical trials, Medicus Pharma has also expanded its portfolio through strategic acquisitions. In August 2025, the company completed the acquisition of Antev Limited, a UK-based late clinical stage biotech company developing Teverelix, a next-generation GnRH antagonist for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate [1].
The acquisition of Antev provides Medicus Pharma with control over three FDA-approved clinical studies, including a Phase 2b study design for advanced prostate cancer and acute urinary retention. The FDA has provided written guidance on the proposed Phase 3 trial design for Teverelix, supporting the Company's clinical plans to develop the drug for advanced prostate cancer patients with increased cardiovascular risk [1].
Medicus Pharma's progress in its clinical programs and strategic acquisitions underscores the company's commitment to advancing innovative treatments for various medical conditions. The company's ongoing Phase 2 studies, including SKNJCT-004 in the UAE and SKNJCT-003 in the US and Europe, aim to bring novel, non-invasive alternatives to market for the treatment of BCC and other conditions.
Medicus Pharma has started its Phase 2 BCC trial in the UAE, enrolling 36 patients across four medical centers. The trial aims to assess the efficacy of its investigational therapy D-MNA compared to a placebo control. The company's broader clinical program targeting BCC continues to advance, with its SKNJCT-003 Phase 2 study underway in the US. Medicus Pharma has also acquired UK-based biotech Antev, gaining control of three FDA-approved clinical studies.
Medicus Pharma Ltd. (NASDAQ:MDCX) has made significant progress in its efforts to develop innovative treatments for basal cell carcinoma (BCC) of the skin. The company has recently initiated its Phase 2 clinical study, SKNJCT-004, in the United Arab Emirates (UAE), with the goal of assessing the efficacy of its investigational therapy, D-MNA, compared to a placebo control. The study commenced patient recruitment at Cleveland Clinic Abu Dhabi (CCAD) and is expected to enroll 36 patients across four medical centers in the UAE [1].The SKNJCT-004 study is designed as a randomized, double-blind, placebo-controlled, multi-center trial, enrolling up to 36 subjects presenting with BCC of the skin. Participants will be randomized 1:1:1 to one of three groups: a placebo-controlled group receiving P-MNA, a low-dose group receiving 100μg of D-MNA, and a high-dose group receiving 200μg of D-MNA. The high-dose, 200μg D-MNA, is the maximum dose used in the Company's Phase 1 safety and tolerability study (SKNJCT-001) completed in March 2021 [1].
Medicus Pharma's broader clinical program targeting BCC continues to advance. The company's SKNJCT-003 Phase 2 clinical study is currently underway in nine clinical sites across the United States and Europe. As of August 2025, SKNJCT-003 has randomized more than 75% of the 90 participants expected to be randomized in the study [1].
In addition to its clinical trials, Medicus Pharma has also expanded its portfolio through strategic acquisitions. In August 2025, the company completed the acquisition of Antev Limited, a UK-based late clinical stage biotech company developing Teverelix, a next-generation GnRH antagonist for cardiovascular high-risk advanced prostate cancer patients and patients with first acute urinary retention relapse (AURr) episodes due to enlarged prostate [1].
The acquisition of Antev provides Medicus Pharma with control over three FDA-approved clinical studies, including a Phase 2b study design for advanced prostate cancer and acute urinary retention. The FDA has provided written guidance on the proposed Phase 3 trial design for Teverelix, supporting the Company's clinical plans to develop the drug for advanced prostate cancer patients with increased cardiovascular risk [1].
Medicus Pharma's progress in its clinical programs and strategic acquisitions underscores the company's commitment to advancing innovative treatments for various medical conditions. The company's ongoing Phase 2 studies, including SKNJCT-004 in the UAE and SKNJCT-003 in the US and Europe, aim to bring novel, non-invasive alternatives to market for the treatment of BCC and other conditions.

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