🇸🇪 AnaCardio raises $19 million to advance first-in-class drug candidate AC01 for heart failure
AnaCardio, a clinical-stage biopharmaceutical company developing novel contractile agents to treat patients with heart failure today announced the completion of a USD 19 million (SEK 205 million) Series A extension financing round, co-led by Novo Holdings, Pureos Bioventures and Sound Bioventures. Current investors Industrifonden, Flerie, and Fredrik and Ann-Helene Ljungström, also participated to complete the round. The raised funds will be used to complete the phase 1b/2a GOAL-HF1 study, and to prepare and initiate start-up activities for the subsequent phase 2b study.
The investment follows the successful completion of the first part of the Company’s phase 1b/2a GOAL-HF1 study in patients with HFrEF. GOAL-HF1 is the first clinical study in patients with AC01, the Company’s novel, selective oral ghrelin receptor (GHSR1a) agonist molecule, which is in development to improve contractility in patients with heart failure. AnaCardio licensed AC01 from the Helsinn Group in February 2022.
In the present study, AC01 was well-tolerated with no Treatment Emergent Adverse Event (TEAE) resulting in treatment discontinuation, and no severe TEAEs. One Serious Adverse Event (SAE) occurred in a patient receiving placebo. No clinically significant changes in blood pressure, arrhythmias or laboratory safety variables were observed. The systemic exposure of AC01 increased in direct proportion to dose and an AC01 concentration-dependent target engagement, expressed as immediate increases in systemic Growth Hormone levels, was demonstrated. Exploratory pharmacodynamic measurements of Cardiac Index and Stroke Volume showed signs of increased contractility, which will be further evaluated in the second part of GOAL-HF1, a phase 2a cohort expansion where patients will be treated for 28 days. This final part of GOAL-HF1 is due to start Q1, 2025, with results expected by the end of the year.
“The study results demonstrate that AC01 is a promising novel inotrope showing signs of increased contractility without adverse effects, such as tachycardia, arrhythmias, ischemia or hypotension which are typically seen with conventional inotropes when administered to patients with heart failure. AC01 proved to be well-tolerated and showed convincing target engagement meriting advancement to the next development stage testing the drug for 28 days to establish proof-of-concept and enable progress to late-stage clinical development”, commented Professor Lars Lund, CSO and Founder of AnaCardio.
AnaCardio’s CEO Patrik Strömberg commented, “This is a landmark day for AnaCardio, where we report a significant financing round, welcome three prominent new investors, and announce the positive outcome of the first study with AC01 in patients. We now have the data and funding to accelerate the further clinical development of our first-in-class inotrope to improve the lives of patients with heart failure”.
Fredrik Lehmann, Venture Partner at Industrifonden, commented: “We are excited to be part of this strong syndicate supporting AnaCardio. The current plan enables us to move into a very interesting Phase 2 trial, which will generate crucial data needed to push forward with this innovative treatment.”
In connection with the new investment, Johan Kördel (Managing Partner, Sound Bioventures), Jørgen Søberg Petersen (Senior Partner, Novo Holdings) and Veronica Gambillara Fonck (Partner, Pureos Bioventures) will join AnaCardio’s Board of Directors. In addition, Viktor Drvota (CEO, Karolinska Development) will replace Per Aniansson on the AnaCardio board. As part of the transaction, Karin Hehenberger, MD, PhD, 3BFuture Health will transition to a board observer role.
Originally published on 9 January by Industrifonden.
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