The world’s largest cardiology meeting, that of the European Society of Cardiology, will kick off this weekend in Barcelona and promises the usual trove of commercially critical data. For starters details could emerge on Merck & Co’s filing plans for anacetrapib, the CETP inhibitor that pulled off a surprise win in the massive Reveal cardiovascular outcomes trial in June.
The Medicines Company will present more data from the phase II Orion-1 trial of its longer-lasting PCSK9 inclisiran, a study that has previously disappointed. And it is a long shot, but renal denervation could finally be rehabilitated with data on Medtronic’s Symplicity Spyral device.
Merck Reveals all?
The full results of Reveal might clarify whether Merck plans to push ahead with anacetrapib – and if not, why not (Merck’s magic touch extends to high-risk heart drug, June 27, 2017). It is possible that the trial has uncovered a serious side effect, or rendered a result that, while statistically significant, is not clinically relevant. The study was 88% powered to show a 15% relative risk reduction, and anything much lower could explain Merck’s reticence.
There is more optimism around Novartis’s anti-inflammatory drug Ilaris and Johnson & Johnson/Bayer’s blood thinner Xarelto. The Compass trial of Xarelto was stopped early for efficacy, and the full data could help investors gauge the chances of a label expansion to include the prevention of cardiovascular events in patients with coronary or peripheral artery disease (Xarelto scores again in huge heart trial, February 9, 2017).
Meanwhile, another large cardiovascular outcomes trial, the Cantos study of Ilaris, also met its primary endpoint. The magnitude of benefit will determine whether Novartis will be able to expand Ilaris’s use from its current rare disease indications into cardiovascular disease, potentially transforming it into a blockbuster (Cantos could make Ilaris a blockbuster, June 22, 2017).
Still hunting for a partner
The ESC data on inclisiran concern the impact of a single or two-dose regimen on LDL cholesterol levels over one year. The project, which uses Alnylam’s RNA interference technology, has a potential advantage over conventional PCSK9s in that it is given quarterly or twice a year. However, the class has not taken off commercially and so far inclisiran’s efficacy appears similar to its forebears (ACC – As Amgen goes, so goes Medicines Company, March 18, 2017).
And the Medicines Company still needs to carry out a cardiovascular outcomes trial, but appears to be waiting for a partner before starting this. Incremental data at ESC might not be enough to help it find one.
The failure of Medtronic’s pivotal US renal denervation trial, Symplicity-HTN 3, in 2014 was so definitive it pretty much annihilated the entire field of research (Decision time for renal denervation firms as Symplicity trial yields little comfort, March 31, 2014). The technique, intended to treat drug-resistant hypertension by scorching nerves with electrodes threaded through the vasculature, has languished ever since despite periodic attempts by various companies to revive it.
One of these attempts, the sham-controlled 170-patient trial Spyral HTN Off-Med, will yield interim data at ESC. This is testing an updated form of the Medtronic’s Symplicity device, the Symplicity Spyral, in patients who have stopped taking their blood pressure drugs. There was some question three years ago over whether the patients in Symplicity-HTN 3 had been adherent to medication or not, potentially confounding the data.
Data from this trial will be crucial in establishing the magnitude of benefit that can be definitively attributed to renal denervation. But that magnitude will have to be sizeable to win over clinicians burned by previous failures.
Alivecor’s smartphone-based electrocardiogram is designed for use not by caregivers but the patients themselves and gained US clearance in 2012. The UK-based Rehearse-AF study is testing whether the AliveCor system can be used to diagnose atrial fibrillation earlier than is possible with standard technologies and reduce the incidence of major cardiovascular events such as stroke.
It has enrolled 1,000 patients diagnosed with various risk factors associated with AF, half of whom used the AliveCor monitor to take an ECG tracing twice a week for 12 months and submit it to the investigators. The other half had their ECGs performed at medical facilities by healthcare staff. If equivalence between the two is shown it ought to be a major boost for the mobile technology.
|Johnson & Johnson/Bayer||Xarelto||Compass||NCT01776424||Sunday August 27|
|Novartis||Ilaris||Cantos||NCT01327846||Sunday August 27|
|The Medicines Company||Inclisiran||Orion-1||NCT02597127||Monday August 28|
|Merck & Co||Anacetrapib||Reveal||NCT01252953||Tuesday August 29|
|Medtronic||Symplicity Spyral||Spyral HTN Off-Med||NCT02439749||Monday August 28|
|Alivecor||AliveCor||Rehearse-AF||-||Tuesday August 29|
To see the full ESC programme, click here.
To contact the writers of this story email Madeleine Armstrong or Elizabeth Cairns in London at email@example.com or follow @ByMadeleineA or @LizVantage on Twitter. Both will be reporting from the conference, which is taking place in Barcelona on August 26-30.