For those interested and keeping in mind the this is about ACF...

For those interested and keeping in mind the this is about ACF not CHF, this is the study the failed primary endpoint that was refer to by @stockrock in this post, interestingly the sample number was 6600 patients significantly larger than the 270 the interim readout is looking at.


Novartis provides update on Phase III study of RLX030 (serelaxin) in patients with acute heart failure
MAR 22, 2017

• Phase III RELAX-AHF-2 study did not meet primary endpoints of reduced cardiovascular death or worsening heart failure in patients with acute heart failure
• Novartis remains committed to improving and extending the lives of patients with cardiovascular disease and will continue to invest in ways to improve their outcomes

Basel, March 22, 2017 - Novartis today announced results from the global Phase III RELAX-AHF-2 study investigating the efficacy, safety and tolerability of RLX030 (serelaxin) in patients with acute heart failure (AHF).

RELAX-AHF-2 did not meet its primary endpoints of reduction in cardiovascular death through Day 180 or reduced worsening heart failure through Day five when added to standard therapy in patients with AHF.

"We are disappointed this study did not confirm the efficacy of RLX030 in acute heart failure, especially given the urgent need for effective new treatments for this condition," said Vas Narasimhan, Global Head, Drug Development and Chief Medical Officer, Novartis. "We will continue to further analyze the data to better understand and learn from these results as well as evaluate next steps for the overall program. Novartis would like to thank the patients, investigators, and site personnel around the world for their unwavering support of this study. We remain committed to improving and extending the lives of patients with cardiovascular disease and will continue to invest in ways to improve their outcomes."

AHF is a life-threatening medical condition requiring urgent evaluation and treatment[1], and is the leading cause of hospitalization in those aged over 65 years[2],[3]. Risk of mortality after hospitalization for AHF is high[4]-[11] with approximately one in five patients not surviving a year afterwards[2],[12]-[14].

About RELAX-AHF-2
RELAX-AHF-2 (NCT01870778) is an event-driven, multicenter, randomized, double-blind, placebo-controlled, Phase III trial designed to evaluate the efficacy, safety and tolerability of RLX030 (serelaxin) when added to standard of care in patients with acute heart failure (AHF). The study has two primary endpoints; reduction of cardiovascular (CV) death through Day 180 and occurrence of worsening heart failure through Day five. The RELAX-AHF-2 study included 6,600 patients hospitalized for AHF and was initiated in October 2013.

About acute heart failure
AHF is a life-threatening condition requiring urgent treatment[1]. An AHF event may occur as a rapid deterioration of existing heart failure (HF), or may be the first presentation of HF. The condition is progressive and can be fatal after patients have one or repeated AHF event(s)[4]. During an AHF event, patients become severely breathless and need to be rushed to the emergency room for urgent treatment, making AHF the most common cause of hospitalization in patients over 65 years[2],[3]. Risk of mortality after hospitalization for AHF is high[4]-[11] with approximately one in five patients not surviving a year afterwards[2],[12]-[14].

Despite significant progress in treating other heart conditions (including chronic HF) there have been no significant treatment breakthroughs that have improved mortality rates in AHF for decades.

About RLX030
RLX030, a relaxin receptor agonist[15], is a recombinant form of the naturally-occurring human relaxin-2 hormone. Human relaxin-2 is present in both men and women and elevated levels in pregnant women are thought to help the body cope with the additional CV demands during pregnancy[16],[17]

About the Novartis cardiovascular portfolio
Entresto® (sacubitril/valsartan) is the first and only approved medicine of its kind. Entresto has been given a Class I recommendation in United States and European Union clinical guidelines for treatment of heart failure with reduced ejection fraction (HFrEF)[18]. Approved indications may vary depending upon the individual country. Its unique mode of action reduces the strain on the failing heart by enhancing the protective neuro-hormonal systems (e.g. natriuretic peptide system) and simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS).

To better understand HF Novartis has established FortiHFy, the largest global clinical program in HF across the pharmaceutical industry. FortiHFy has more than 40 active or planned clinical studies designed to extend understanding of HF as well as to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real world evidence with Entresto.

In addition to CV research in HF, ACZ885 (canakinumab) is currently being investigated in patients with a previous heart attack and a high degree of vascular inflammation. The Phase III CANTOS trial is designed to determine if ACZ885 can reduce the risk of stroke, heart attack or death and is expected to read out in 2017.