AnaCardio raises €62.5M to test heart failure drug
Swedish biotech AnaCardio has raised €62.5 million to take its oral heart failure drug AC01 through Phase 2b, testing whether early improvements in pumping function hold up in a larger patient population.
Zoom in: Novo Holdings and the Ljungström family office co-led the Swedish biotech’s Series B. The financing will fund a roughly 400-patient trial, with the aim of making AC01 ready for Phase 3 by 2028.
- Helsinn, Pureos Bioventures, Sound Bioventures, Industrifonden, Flerie and LLD Nybohov Invest also participated in the financing, alongside new investor Innovestor Life Science. AnaCardio has now raised around €100 million.
- A similar group of investors, including Novo Holdings, the Ljungström family, Sound Bioventures and Innovestor Life Science also invested in Breye Therapeutics’ €67.5 million Series A announced yesterday.
Why it matters: Patients with heart failure with reduced ejection fraction (HFrEF) can remain symptomatic despite existing therapies. Drugs that directly strengthen the heart’s contractions could help, but conventional inotropes carry risks including arrhythmias, ischemia and increased mortality, limiting their long-term use.
- “Improving cardiac contractility safely remains a major unmet need in heart failure,” said Jørgen Søberg Petersen, senior partner at Novo Holdings.
How it works: AC01 activates the receptor for ghrelin, a hormone best known for regulating appetite that also affects cardiac function. The small molecule is designed to make heart muscle more responsive to calcium, strengthening contractions through a different mechanism from conventional inotropes.
- AnaCardio licensed the compound from Helsinn. Its heart failure program builds on research led by Lars Lund at Karolinska Institutet showing that activating ghrelin signaling could improve cardiac function.
The evidence: In the Phase 1b/2a GOAL-HF1 study, patients receiving AC01 at 3 mg twice daily had a 22% increase in cardiac output from baseline after 28 days.
- Left ventricular ejection fraction — the proportion of blood pumped out with each contraction — increased by 4.8 percentage points, compared with 1.6 points on placebo.
- The company reported no evidence of tachycardia, new sustained arrhythmias, ischemia or symptomatic hypotension. Results were published in The Lancet in June.
The competition: AnaCardio joins other developers trying to improve contraction without the drawbacks of traditional inotropes.
- Cytokinetics’ oral cardiac myosin activator omecamtiv mecarbil is already in the confirmatory Phase 3 COMET-HF trial in patients with severely reduced ejection fraction. Its earlier GALACTIC-HF trial reduced the composite risk of cardiovascular death or heart failure events, but did not reduce cardiovascular death alone. The FDA rejected its application in 2023, requiring additional evidence.
- Kardigan’s danicamtiv, another oral myosin activator, is in an adaptive Phase 2b/3 trial focused on genetic and familial dilated cardiomyopathy, a narrower population. Phase 3 enrollment is underway, with Phase 2b data expected in the first half of 2027.
What’s next: AnaCardio expects to enroll the first participant in GOAL-HF2 in the fourth quarter of 2026. The randomized, placebo-controlled trial will test two AC01 doses over 12 weeks at about 100 sites across North America and Europe.
