Company: MDCXW
Filing Date: 2025-09-29
Form Type: S-1
Source: 0001062993-25-015841
Chunk: 138

Company: Medicus Pharma Ltd.
Filing Date: 2025-09-29
Form: S-1
Chunk 138
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 of CV-related adverse events.

Clinical Development

In September 2020, Antev completed a Phase 1 clinical trial in which Teverelix was shown to be well tolerated with no dose-limiting toxicities and demonstrated rapid testosterone suppression. The study included 48 healthy male volunteers. In February 2023, Antev also completed a Phase 2a study in 50 patients with advanced prostate cancer, where Teverelix achieved the primary endpoint of greater than 90% probability of castration levels of testosterone suppression (97.5%), but the secondary endpoint of maintaining this rate above 90% was not met with the probability dropping to 82.5% by day 42.

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In January 2023, the FDA reviewed the Phase 1 and Phase 2a data and provided written guidance on Antev's proposed Phase 3 trial design for Teverelix. This supports the Company's clinical plans to develop Teverelix as a treatment for advanced prostate cancer patients with increased cardiovascular risk.

In December 2023, the FDA approved a Phase 2b open label study designed to recruit 40 men with advanced prostate cancer suitable for ADT. The participants will receive a loading dose of 180mg via intramuscular injection plus two 180mg doses via subcutaneous injection (total dosage of 540mg), followed by two 180mg doses (total dosage of 360mg) via subcutaneous injection on day 29 and every 6 weeks. The total duration of the treatment is 22 weeks. The primary endpoint is to confirm castration rate by day 29, sustaining to day 155, with a probability greater than 90%.

In November 2024, the FDA approved a Phase 2b study of Teverelix to treat AUR. The planned Phase 2b study is a randomized controlled double-blind study involving 390 men after a successful trial without catheterization in 60 to 70 sites in the United States and European Union. The patients will receive either a single intramuscular or a single subcutaneous injection (90 mg or 120 mg) or placebo in addition to standard therapy. The primary endpoint for the Phase 2b study is a composite of AUR, need for surgery or poor urinary flow metrics in the first 28 weeks plus 24 weeks follow up.

Patent Protection

Composition of matter patents for Teverelix have a natural expiration in 2039 and pending method of use patent applications, if