Swiss pharmaceutical giant Novartis recently announced mixed data from a phase III study of its acute heart failure (AHF) candidate RLX030 (serelaxin).
The study met one of its two primary objectives of reducing dyspnea (shortness of breath) in patients suffering from AHF. Novartis also reported that RLX030 lessened all-cause and cardiovascular mortality rate by 37% in patients suffering from AHF compared to placebo after six months.
The phase III study, however, failed to meet its secondary objectives of days alive and out of hospital and cardiovascular death or re-hospitalization due to heart or kidney failure up to day 60. The second co-primary endpoint was also not achieved.
Novartis is discussing the phase III results with regulatory authorities around the globe. The company, along with its wholly owned subsidiary Corthera Inc., has worldwide rights to RLX030 (except in Canada).
Given the mixed data on the candidate, the company could be required to conduct an additional study depending on the label.
We note that Novartis has several candidates under development for the treatment of heart failure. In August this year, the company announced positive results from a phase II study of LCZ696, which showed significant reduction in a key indicator of morbidity and mortality in patients suffering from chronic heart failure with preserved ejection fraction (HF-PEF). The heart failure market currently has players like Takeda Pharmaceutical Company Limited and Merck & Co .
Novartis also received encouraging news on its Cushing's disease candidate Signifor (pasireotide). The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) provided a positive opinion on the candidate to treat patients suffering from Cushing's disease and who required medical therapeutic intervention.
The advisory panel’s support for the candidate was based on positive data from the phase III PASPORT-CUSHINGS (PASireotide clinical trial PORTfolio - CUSHING'S disease) study on Signifor.
We remind investors that in April this year, Signifor was approved in the EU for the treatment of Cushing's disease.
Currently, we have a Neutral recommendation on Novartis. Novartis carries a Zacks #3 Rank (Hold rating) in the short run.