Medicus Pharma has received positive feedback from FDA and central institutional review board (IRB) approval for an optimised Phase 2 clinical trial evaluating Teverelix in men following a first episode of acute urinary retention associated with benign prostatic hyperplasia (BPH).

The company said the redesigned Phase 2 study, known as Ant-2111-02, is expected to enrol around 126 patients across the USA and Europe, compared with approximately 390 patients under its previous development plan. The revised study is intended to assess the effects of Teverelix on prostate volume and urinary function while supporting dose optimisation and future clinical development.

According to Medicus, FDA provided seven recommendations covering protocol implementation, safety monitoring and study documentation. The company said the comments are operational in nature and do not require changes to the study’s scientific rationale, patient population, treatment arms, primary endpoint or planned interim analysis.

The protocol has also received approval with modifications from central IRB Advarra. The requested changes relate to informed consent documentation, while individual study sites must still complete local approvals before patient recruitment can begin.

Dr Raza Bokhari, executive chairman and chief executive officer of Medicus Pharma, said: “FDA’s positive feedback and central IRB approval represent meaningful progress toward advancing our Teverelix Program.

“Acute urinary retention is a serious and distressing complication frequently associated with benign prostatic hyperplasia. By redesigning this study, we believe we have transformed the Teverelix development program into a substantially more efficient clinical strategy, reducing anticipated enrollment from approximately 390 patients to approximately 126 patients while preserving our ability to generate decision-grade clinical evidence.”

Acute urinary retention is a medical emergency in which a person is suddenly unable to urinate. It is a serious complication of benign prostatic hyperplasia and often requires emergency catheterisation, with many patients experiencing recurrent episodes or progressing to surgical treatment.

The randomised, double-blind, placebo-controlled Phase 2 study will investigate whether Teverelix can reduce prostate volume and lower the risk of recurrent acute urinary retention while also assessing urinary function, safety and treatment durability.

Medicus said it is now working with regulatory and clinical partners to incorporate FDA recommendations, finalise participating clinical sites and complete study start-up activities before initiating patient enrolment.