Cell Therapy to Restore Function in Heart Failure Dosed to First Patient, Novo Nordisk and Heartseed Announce
15 February 2023
Collaborations, Mergers & Acquisitions
Regulatory & Standards
Heartseed Inc (Tokyo, Japan) and Novo Nordisk (Bagsværd, Denmark) have announced that the first patient has been dosed with HS-001 in Heartseed’s Phase I/II clinical study on advanced heart failure.
Heart failure is a chronic and progressive condition limiting heart function and effecting more than 65 million people worldwide.
There are currently no cures for heart failure. More than half of the people diagnosed with heart failure will die within five years.
Under the two Companies’ 2021 Partnership agreement, Heartseed maintain the rights to develop HS-001 in Japan, with the therapy being co-commercialized by both Heartseed and Novo Nordisk in this location.
Elsewhere Novo Nordisk will solely develop, manufacture and commercialize the therapy, with Heartseed set to receive milestone payments and royalties of annual net sales outside of Japan.
“Cell therapy holds the promise to offer truly disease-modifying treatments for people living with serious chronic disease. We are very pleased that our partners from Heartseed have begun clinical testing of this innovative approach to treating heart failure,” said Jacob Sten Petersen, corporate vice president of Cell Therapy R&D in Novo Nordisk.
HS-001 is an investigational cell therapy for advanced heart failure caused by ischemic heart diseases, under Phase I/II evaluation in the 52-week, open-label, dose-escalation study, Lapis.
The cell therapy is designed to restore heart muscle function and consists of clusters of purified heart muscle cells induced from iPSCs.
Previous preclinical studies indicate that iPSC-derived cardiomyocytes have the ability to improve heart function.
HS-001 is transplanted into the patients diseased heart tissue during a coronary artery bypass graft procedure.
Lapis will see a total of 10 patients enrolled in 2 dose cohorts – 50 million, and 150 million cardiomyocytes.
The primary endpoint of the study will be determined by safety at 26-weeks post-transplantation, with secondary efficacy endpoints to include left ventricular ejection fraction and myocardial wall motion.
Initial 4-week data gathered from the first patient dosed in the Lapis study has been evaluated by an independent safety committee and approved for continuation.
“As a cardiologist, I have been working for many years to realize cardiac regeneration medicine in order to treat patients with heart failure whose heart function has deteriorated to the point where they are unable to live their daily lives. To achieve this goal, we established Heartseed and have continued our development with patient safety and benefit as our top priority,” said Keiichi Fukuda, CEO of Heartseed.