European filing for naproxcinod is expected to follow by year-end.
NicOx completed a €30 million (about $44.92 million) private placement with institutional investors. The company separately reported that the FDA accepted its NDA submission for lead osteoarthritis drug, naproxcinod.
The fundraising included a €20 million (about $29.95 million) cornerstone investment by Fonds Stratégique d’Investissement (FSI), which as a result now owns 5.1% of NicOx. Proceeds from the financing round will be used to support NicOx’ drive to become a fully integrated specialty pharmaceuticals company.
NicOx is focused on developing a pipeline of nitric oxide-donating drugs. Naproxcinod is a cyclooxygenase-inhibiting nitric oxide-donating (CINOD) anti-inflammatory agent being developed for relieving the signs and symptoms of osteoarthritis. In addition to its recent NDA submission, NicOx says that it also aims to file for regulatory approval in Europe by the end of this year.
Just last week the company reported positive results from a Phase Ib study with NCX 6560, a nitric oxide-donating HMG-CoA reductase inhibitor in development for cardiovascular indications. The trial, evaluating NCX 6560 versus placebo and Lipitor®, met its primary and secondary endpoints and demonstrated a strong cholesterol-lowering effect in patients with high baseline LDL cholesterol levels.
“The role of NO in preventing pathological processes in the vasculature suggests NCX 6560 could have the potential to reduce the occurrence of serious cardiovascular adverse events such as stroke and heart attack in coronary heart disease patients,” notes Pascal Pfister, CSO and head of R&D at NicOx. “In light of these results, we are keen to see NCX 6560 advanced into Phase II.”
