Medicus Pharma Ltd. (NASDAQ:MDCX) said Monday it has submitted an optimized Phase 2 study design to the U.S. Food and Drug Administration under its existing Investigational New Drug application for Teverelix. It is an investigational therapy targeting benign prostatic hyperplasia-related complications.
Streamlined Study Targets Faster Clinical Insights
The revised trial design focuses on evaluating Teverelix, a GnRH antagonist, for preventing recurrent acute urinary retention in men with benign prostatic hyperplasia.
The indication represents an estimated $2 billion market opportunity.
The updated Phase 2 study, designated ANT-2111-02, reduces the sample size to approximately 126 patients while emphasizing the detection of a clear pharmacodynamic signal, specifically prostate volume reduction.
The company said the revised structure also enables differentiation across dosing and administration routes.
Reduced Size, Lower Costs, Improved Efficiency
The company noted that the optimized design reflects a data-driven shift, cutting the study size by roughly threefold compared to the earlier plan. The reduction is expected to lower development costs while improving execution speed and operational efficiency.
Management added that the streamlined approach could support earlier strategic discussions, including potential partnering opportunities, as clinical data becomes available more quickly.
Medicus Pharma Trial Design And Key Endpoints
The randomized, double-blind, single-dose study will include four arms, with patients receiving either Teverelix 90 mg via intramuscular injection, Teverelix 120 mg subcutaneously, or matched placebo controls.
All participants will receive a single dose on Day 1 while continuing standard alpha-blocker therapy.
The trial will span 52 weeks, including a 28-week treatment period followed by 24 weeks of follow-up.
The primary endpoint focuses on the percentage change in total prostate volume at Week 12, aiming to establish an early pharmacodynamic signal.
Secondary measures include maximum urine flow rate, post-void residual volume, recurrence of urinary retention, and the need for intervention.
An interim analysis is planned once approximately half of the participants complete the 12-week assessment, which is expected to guide dose selection, administration route, and the design of a potential Phase 3 study.
MDCX Stock Price Activity: Medicus Pharma shares were down 4.92% at $0.43 during premarket trading on Monday, according to Benzinga Pro data.
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