Idorsia (IDIA) Status Update summary

Innovation and Clinical Differentiation

• TRYVIO is the first FDA-approved therapy targeting the endothelin pathway for systemic hypertension, offering a novel mechanism for patients with difficult-to-control hypertension after decades of limited progress.

• Endothelin regulation is central to hypertension and was previously unaddressed, especially in high-risk groups such as African Americans, elderly, postmenopausal women, obese patients, and those with CKD, diabetes, heart failure, or sleep apnea.

• TRYVIO blocks both ETA and ETB receptors, providing multifaceted benefits without affecting healthy volunteers, supporting its safety and tolerability.

• Included in updated ACC/AHA clinical practice guidelines, TRYVIO addresses a significant unmet need for patients not adequately controlled on other antihypertensive drugs.

• TRYVIO is nominated for the 2025 Prix Galien USA Awards for Best Pharmaceutical Product.

Clinical Evidence and Patient Targeting

• The PRECISION phase 3 trial showed meaningful blood pressure reduction within two weeks, sustained over 48 weeks, with a 19mmHg decrease in resistant hypertension patients.

• TRYVIO demonstrated efficacy and safety across high-risk subgroups, with only mild, transient edema and modest hemoglobin decrease as side effects, and no drug-drug interactions.

• TRYVIO showed unique efficacy in reducing nighttime blood pressure, a strong predictor of poor outcomes.

• Blood pressure-lowering effects were consistent across age, sex, race, BMI, kidney function, and diabetes status.

• In patients with CKD stage 3/4, TRYVIO achieved unprecedented BP reductions and significant decreases in urine albumin-to-creatinine ratio, with stable eGFR over 48 weeks.

Market Opportunity and Commercial Strategy

• Nearly 26 million US patients could be eligible for TRYVIO, representing a substantial market opportunity, with 7 million easily identifiable for initial targeting.

• TRYVIO is approved for patients with EGFR as low as 15, with no hyperkalemia or hypotension, and is favorably viewed by physicians and payers for its efficacy and safety.

• The product is being reimbursed with reasonable utilization management, and retail pharmacy distribution is being rolled out following REMS removal.

• Geographic expansion opportunities exist in the EU, UK, Japan, and China, with further value possible through IP extension and indication expansion.

• TRYVIO is approved and commercially available in the US since October 2024; also approved as JERAYGO in the EU and UK, with applications under review in Canada and Switzerland.