Medicus Pharma has received authorisation from the UAE Department of Health – Abu Dhabi to begin a Phase 2a clinical study evaluating Teverelix in women with moderate-to-severe symptomatic endometriosis.

The PRECISION-E2 study will investigate whether genomic and biological data can help identify women who are more likely to respond to treatment with the long-acting GnRH antagonist.

The prospective, randomised, placebo-controlled study is expected to enrol approximately 84 women with moderate-to-severe symptomatic endometriosis across multiple sites in the United Arab Emirates.

The regulatory authorisation follows a review of the study’s chemistry, manufacturing and controls, non-clinical, clinical and safety documentation. The study can proceed subject to site-specific Institutional Review Board and ethics approvals.

Study will assess different Teverelix doses

Participants will be randomised into four treatment groups, receiving either 60mg of Teverelix administered subcutaneously, 90mg administered subcutaneously, 90mg administered intramuscularly or placebo administered subcutaneously.

The primary pharmacodynamic endpoint is the proportion of participants who achieve and maintain serum estradiol within the established Barbieri therapeutic window of approximately 20-50 pg/mL for at least 14 consecutive days following treatment.

The study will also assess pharmacokinetic parameters, hormonal and bone turnover biomarkers, safety, immunogenicity, endometriosis-associated pain and quality of life.

Exploratory genomic analyses will investigate potential links between genetic characteristics and treatment response.

Medicus said the study is designed to explore whether combining clinical, pharmacodynamic and genomic data can identify potential biomarkers associated with controlled estradiol suppression, clinical benefit and treatment tolerability.

Any potential treatment-response biomarkers or multi-gene signatures identified through the study would need to be confirmed in subsequent clinical research before being used to guide patient selection.

“Today’s IND authorization represents far more than approval to initiate another clinical study,” said Raza Bokhari, executive chairman and CEO of Medicus Pharma. “It validates a development strategy designed to combine precision endocrinology, pharmacology and population genomics within a prospective clinical trial.”

Bokhari added that the company believes the study could help inform the future development of Teverelix and research into personalised treatment approaches for endometriosis and other estrogen-driven diseases.

Genomics to be explored alongside clinical data

PRECISION-E2 will integrate genomic information with endocrine pharmacology, pharmacokinetics, biomarkers, safety assessments and patient-reported outcomes.

The planned analyses include whole-genome information, subject to applicable approvals and governance requirements, alongside measurements of estradiol, luteinising hormone and follicle-stimulating hormone.

Researchers will also examine pharmacokinetic exposure, bone turnover biomarkers, clinical symptoms, quality-of-life outcomes and safety and tolerability.

The exploratory genomic work will focus on predefined genes and biological pathways linked to estrogen receptor signalling, estrogen synthesis and metabolism, gonadotropin signalling, endometriosis biology, inflammatory pathways and pain perception.

Candidate genes include ESR1, ESR2, CYP19A1, GNRHR, FSHR and LHCGR.

The approach is intended to help researchers understand why individual women may respond differently to hormonal therapies and could inform future development of Teverelix.

Endometriosis remains an unmet need

Endometriosis affects approximately one in 10 women of reproductive age worldwide and can cause chronic pelvic pain, painful periods and infertility.

The condition can also have a wider impact on education, employment, family planning, emotional wellbeing and quality of life.

While several treatments are available, some women continue to experience inadequate symptom control, adverse effects, recurrence after treatment stops or differences in how they respond to therapy.

Medicus said PRECISION-E2 has been designed to assess whether Teverelix can achieve rapid, controlled and sustained estradiol suppression while also generating data that could help inform future dose selection and route of administration.

The study will therefore combine assessment of the drug’s pharmacodynamic effects with clinical outcomes and exploratory genomic analysis.

The company is developing Teverelix as a potential treatment for women with moderate-to-severe symptomatic endometriosis, with PRECISION-E2 intended to provide early data on its pharmacological effects and potential treatment-response markers.