Salubris Biotherapeutics has reported positive updated results from its ongoing Phase Ib clinical trial evaluating JK07 in heart failure with reduced ejection fraction (HFrEF).

JK07 is claimed to be the first investigational antibody fusion protein as well as the first selective ErbB4 agonist to enter clinical development.

Single doses of JK07 were intravenously administered to participants, and changes from baseline values were measured of left ventricular EF of each patient.

The trial had seen 14 participants, who were randomised 3 to 1.

The participants were divided into three cohorts, with the first cohort receiving 0.03mg/kg of JK07, second being administered 0.09mg/kg and third 0.27mg/kg dose.

After a single administration of JK07, patients in all the cohorts showed improvement in ejection fraction through Day 90.

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JK07 was also found to be well-tolerated with the only serious adverse event occurring at the top dose level.

SalubrisBio CEO Sam Murphy said: “Heart failure is a leading cause of morbidity and mortality in the US and globally.

“These new interim results demonstrate that JK07 achieved robust target engagement and encouraging signs of potential clinical benefit with a single administration.

“The durable and sustained responses observed, coupled with a favorable safety profile, support further investigation of JK07.”

The data was presented during the annual congress of the European Society of Cardiology’s Heart Failure Association.

In September 2022, the firm reported positive interim results on the Phase 1b study of JK07. 

Following the Phase Ib trial findings, Salubris intends to initiate a repeat-dose, randomised, double-blind Phase II trial of JK07, which is slated to commence in the second half of this year.

A wholly owned subsidiary of the Shenzhen Salubris Pharmaceuticals, Salubris is also engaged in developing complex biologics for oncology, and neurodegenerative along with cardiovascular diseases.

Heart failure is a serious health condition impacting nearly 6.5 million Americans and causing one in eight deaths in the US.