The trial is seeking to examine SalubrisBio’s JK07, a recombinant antibody fusion protein designed to produce regenerative effects on the heart through signalling interactions with two different receptors. Credit: Shutterstock / Emily frost.

US company Salubris Biotherapeutics (SalubrisBio) has seen its heart failure therapy, JK07, achieve some success in interim results taken from an ongoing Phase II trial examining its treatment in patients living with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF).

The trial aims to examine the candidate, which comprises a recombinant antibody fusion protein designed to produce regenerative effects on the heart through signalling interactions with two different receptors, notably ErbB3 and ErbB4.

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SalubrisBio said that interim data from the RENEU-HF trial (NCT06369298) found that low doses of JK07 proved to be well tolerated with consistent target engagement over repeated administration of the drug.

The randomised, double-blind, placebo-controlled trial is still ongoing, to enrol 282 subjects who will be chosen to receive multiple doses of JK07 or placebo, with the primary endpoint for the HFrEF group being improvement in ejection fraction, whilst the primary endpoint for the HFpEF group is safety and tolerability.

The interim data covers 68 of those enrolled patients and additionally found no meaningful differences in adverse event frequency and severity between active and placebo groups. The company added that it will present data analysis on its primary endpoints sometime in 2026.

SalubrisBio’s chief medical officer Shalabh Singhal said: “We are encouraged by the safety profile and early efficacy trends from this interim analysis of RENEU-HF. The data continue to suggest that JK07 has the potential to improve function and long-term outcomes in heart failure patients.

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“We look forward to building on these promising findings and advancing a potential new treatment option that improves heart function and quality of life for heart failure patients.”

The US Centres for Disease Control (CDC) estimates that there are 6.7 million Americans over the age of 20 years currently living with some form of heart failure, costing the country an estimated $30.7bn in 2012.

Research by GlobalData estimates that by the end of this year, the global market for diastolic heart failure treatments is set to reach $56m, with that figure estimated to rise to $3.5bn by the end of 2030.

GlobalData is the parent company of Clinical Trials Arena.

Elsewhere in the field of heart failure, Texas-based Alleviant Medical has secured $90m to fund a second pivotal trial of the company’s heart system to treat HFrEF. Meanwhile, German-American medical device company Reprieve Cardiovascular is eyeing up a pivotal trial with its cardiovascular drainage device after reporting success from a first-in-human study.