PCSK9 inhibitors typically are used to pursue cholesterol-reduction indications. But a new deal from Novartis ($NVS) outlicenses its Phase II-ready, anti-PCSK9 antibody for a couple of inflammatory indications that include sepsis.
The cholesterol-lowering activity of the antibody is seen as a key mechanism of action to prevent and improve outcomes for patients with, or at risk for, sepsis.
Vancouver-based Cyon Therapeutics will pick up worldwide rights to the candidate, LGT-209, for use in systemic inflammatory response syndrome (SIRS) and for the prevention and treatment of sepsis. Financial details of the deal were undisclosed, although regulatory and commercial milestones are included.
Founded in 2014 by a trio of physicians, Cyon is starting to raise a venture round. It expects to initiate a Phase II trial of LGT-209 during the first half of next year.
"Cyon's novel discovery work highlighting a key role of PCSK9 levels and genotype with predisposition to organ failure in the ICU setting, can now advance immediately into a Phase II RCT of this anti-PCSK9 antibody. LGT-209 could be positioned to be a broad spectrum complement to all antibiotics in severe infection", Cyon CEO Dr. John Boyd said in a statement.
The company plans to use LGT-209 as a novel means to clear endotoxin and other bacterial toxins out of a patient’s system. The planned Phase II clinical trial will include biomarkers for patient selection that are intended to predict response to the anti-PCSK9 antibody. It’s slated to be in patients early in the disease process that results in sepsis, in an effort to reduce the morbidity and mortality associated with it.
The candidate has already been developed through Phase I/II; Phase I testing found LGT-209 to be safe and well-tolerated--and effective at lowering cholesterol.
Cyon has been backed thus far with collaborations and grants from the Centre for Drug Research and Development (CDRD), Genome BC and the National Research Council of Canada (NRC), including the Industrial Research Assistance Program.
- here is the release