Medicus files IND for genomics-enabled Phase 2 endometriosis trial

Medicus Pharma has submitted an investigational new drug application in Abu Dhabi for a Phase 2a study evaluating Teverelix in women with endometriosis, with the trial incorporating genomic analyses through the Emirati Genome Program.

The PRECISION-E2 study will assess the pharmacodynamics, safety, tolerability and clinical activity of the investigational long-acting GnRH antagonist in approximately 84 women with moderate-to-severe symptomatic endometriosis across multiple sites in the United Arab Emirates.

A key feature of the trial is its planned integration with the Emirati Genome Program, enabling researchers to investigate whether genetic variation influences response to treatment. The study will combine genomic analyses with clinical outcomes, hormonal biomarkers, pharmacokinetic and pharmacodynamic data and patient-reported measures.

Participants will be randomised to one of three Teverelix treatment regimens, administered either subcutaneously or intramuscularly, with the aim of identifying an approach that achieves controlled oestradiol suppression while maintaining an acceptable safety profile.

Investigators also plan to examine potential associations between genetic variation in oestrogen-signalling and gonadotropin pathways and treatment response, symptom improvement and safety outcomes.

Raza Bokhari, executive chairman and chief executive officer of Medicus Pharma, said: “To our knowledge, this is among the first prospective studies evaluating a long-acting GnRH antagonist in endometriosis through a precision medicine framework.”

He added: “We believe this approach has the potential to help transform the management of endometriosis from a one-size-fits-all treatment paradigm toward a more personalized and data-driven model of care.”

Endometriosis affects an estimated one in 10 women of reproductive age worldwide and is associated with chronic pelvic pain, dysmenorrhoea and infertility. Despite available therapies, many patients continue to experience inadequate symptom control or treatment-limiting side effects.

Medicus said successful completion of the study could support further clinical development of Teverelix in endometriosis while informing research into other oestrogen-driven conditions, including uterine fibroids.

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