JK07 treatment for heart failure with combined post- and pre-capillary pulmonary hypertension

A Phase 2a, Open-Label Study to Assess the Safety, Tolerability, and Efficacy of JK07 in Participants With Heart Failure and Group 2 Combined Post-Capillary and Pre-Capillary Pulmonary Hypertension (RENEU-PH)

This trial will try a high dose of an experimental drug called JK07 in adults with heart failure and combined post‑ and pre‑capillary pulmonary hypertension to see if it is safe, tolerable, and improves heart and lung pressures.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Salubris Biotherapeutics Inc (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Tulsa, Oklahoma)
• Trial ID: NCT07221513 on ClinicalTrials.gov

What this trial studies

This Phase 2a, open-label, multiple-dose study will enroll about 20–30 adults with heart failure (either HFrEF or HFpEF) who have combined post- and pre-capillary pulmonary hypertension confirmed by right heart catheterization. Participants will receive a high dose of JK07 and be monitored for safety, tolerability, and signals of efficacy over the dosing period. Key inclusion requires NYHA class II–III and hemodynamic criteria (mPAP ≥25 mmHg, PAWP ≥16 mmHg, and PVR ≥2.5 WU) measured by RHC, and major exclusions include other WHO groups of pulmonary hypertension, significant lung disease, and BMI >45 kg/m2. The trial is conducted at Saint Francis Heart and Vascular Institute in Tulsa, Oklahoma and is open-label without a placebo control.

Who should consider this trial

Good fit: Adults 18–85 with NYHA class II–III heart failure (HFrEF or HFpEF) and right-heart-catheterization–confirmed combined post‑ and pre‑capillary PH (mPAP ≥25 mmHg, PAWP ≥16 mmHg, PVR ≥2.5 WU) are the intended participants.

Not a fit: Patients with WHO Group 1, 3, 4, or 5 pulmonary hypertension, significant pre-existing lung disease, contraindication to a prolonged right heart catheterization, or BMI >45 kg/m2 are unlikely to qualify or benefit from this treatment.

Why it matters

Potential benefit: If successful, JK07 could lower pulmonary pressures and improve symptoms and exercise capacity in patients with heart failure and combined post‑ and pre‑capillary pulmonary hypertension.

How similar studies have performed: Drugs targeting the pulmonary vasculature have proven benefit in Group 1 PAH but have shown limited or mixed results in Group 2 cpcPH, so this approach is relatively novel and unproven in this specific population.

Eligibility criteria

Key Inclusion Criteria:

* Participants with HF New York Heart Association Class II-III.
* Participants will be classified as having HFrEF (LVEF ≤ 40%) or HFpEF (LVEF \>40% and ≤70%).
* Right heart catheterization (RHC) based evidence of cpcPH:
* PVR ≥2.5 WU; AND
* mPAP ≥25 mmHg; AND
* PAWP ≥16 mmHg

Key Exclusion Criteria:

* Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
* Contraindicated to RHC that can be left in place for approximately 6 hours.
* A diagnosis of pre-existing lung disease including congenital abnormalities, full or partial pneumonectomy, or previous therapeutic radiation of lungs or mediastinum.
* Body mass index (BMI) \>45 kg/m² at screening.

Where this trial is running

Tulsa, Oklahoma

• Saint Francis Heart and Vascular Institute — Tulsa, Oklahoma, United States (RECRUITING)

Study contacts

• Study coordinator: Amanda McEwen

Conditions: HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension, Heart Failure, Heart Failure with Reduced Ejection Fraction, HFrEF, HFpEF, Heart Failure with Preserved Ejection Fraction