Study of JK07 in Patients With Heart Failure and WHO Group 2 Combined Post- and Pre-Capillary Pulmonary Hypertension

NCT07221513 — Phase 2, Withdrawn, Salubris Biotherapeutics Inc

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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)

Registry	NCT07221513, acronym RENEU-PH
Status	Withdrawn - Sponsor decision
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Sponsor	Salubris Biotherapeutics Inc (Industry)
Conditions	HFrEF - Heart Failure With Reduced Ejection Fraction, HFpEF - Heart Failure With Preserved Ejection Fraction, Group 2 Pulmonary Hypertension
Interventions	JK07 (Drug)
Dates	start 2025-12-15, primary completion 2026-04-16, completion 2026-04-16, first posted 2025-10-28, last updated 2026-05-15
Locations	1 site in United States

-Summary

This is a Phase 2a, open-label, multiple-dose study to assess the safety, tolerability, and efficacy of JK07 in participants 18 to 85 years of age with diagnosed HF and cpcPH.

At least 20 and up to approximately 30 participants will be enrolled and receive JK07 high dose in this open-label trial.

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+Arms and interventions

Arm	Type	Interventions	Description
JK07 high dose	Experimental	Drug: JK07	JK07 administered by intravenous (IV) infusion

JK07 (Drug): JK07 is a fully human anti-human epidermal growth factor receptor 3 (also known as ErbB3 or HER3) antibody fused with the epidermal growth factor (EGF)-domain of Neuregulin (NRG)-1b protein.

+Outcome measures

Primary outcomes

Incidence and severity of TEAEs [Safety and tolerability] [Study entry through week 26]: Incidence and severity of treatment emergent adverse events

Secondary outcomes

Pharmacokinetic - Cmax [Study entry through week 26]: Characterize the JK07 PK profile through Peak Plasma Concentration (Cmax) following IV administration
Pharmacokinetics - Tmax [Study entry through week 26]: Characterize the JK07 PK profile through Time to Peak Plasma Concentration (Tmax) following IV administration
Pharmacokinetics - AUC0-last [Study entry through week 26]: Characterize the JK07 PK profile through area under the concentration-time curve from time 0 to last quantifiable concentration (AUC0-last) following IV administration
Pharmacokinetics - AUC0-inf [Study entry through week 26]: Characterize the JK07 PK profile through area under the concentration-time curve from time 0 to infinity (AUC0-inf) following IV administration
Pharmacokinetics - t1/2 [Study entry through week 26]: Characterize the JK07 PK profile through half-life (t1/2) following IV administration
Pharmacokinetics - λz [Study entry through week 26]: Characterize the JK07 PK profile through elimination rate constant (λz) following IV administration
Pharmacokinetics - CL [Study entry through week 26]: Characterize the JK07 PK profile through systemic clearance (CL) following IV administration
Pharmacokinetics - Vz [Study entry through week 26]: Characterize the JK07 PK profile through volume of distribution (Vz) following IV administration

+Eligibility

Sex: All, ages: 18 Years to 85 Years

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.

+Locations (1)

Facility	City	Country	Status
Saint Francis Heart and Vascular Institute	Tulsa, Oklahoma	United States