ESC 2020 roundup – Amarin touts plaque data as appeal looms

A virtual ESC sees Vascepa’s plaque reduction, Ionis’s second-gen candidates and Medtronic’s cryoblation win.

The stand-out data at this year’s European Society of Cardiology congress undoubtedly came from the Dapa-CKD study of Astrazeneca’s Farxiga. The trial, presented on Sunday, found an impressive benefit with the SGLT2 inhibitor in patients with chronic kidney disease, both with and without diabetes.

But plenty more companies turned out for the virtual meeting. One of the most intriguing reports involved Amarin’s Vascepa, which reduced levels of coronary plaque in a small study. The 80-patient Evaporate trial found a 17% reduction in plaque volume at 18 months in patients treated with the drug, while those in the placebo group saw their plaque volume more than double.

The data were presented at ESC on Saturday and published simultaneously in the European Heart Journal.

Amarin got more good news on Monday with the failure of Acasti Pharma’s rival project, CaPre, in a second phase III trial, Trilogy-2. Acasti has now given up on CaPre, something that had been on the cards since Trilogy-1 flunked in January.

However, the bigger issue for Amarin is whether it will prevail in its appeal against the invalidation of key patents covering Vascepa. With oral arguments set to be heard tomorrow, there might soon be an indication of which way the case will go.

Talking antisense

Saturday also saw phase II data from two second-generation antisense projects from Akcea and Ionis: the Pfizer partnered AKCEA-ANGPTL3-LRx, now known as vupanorsen; and AKCEA-APOCIII-LRx, now wholly owned by Ionis and Akcea after being ditched by Novartis in December. Both assets are designed to lower triglycerides to protect against cardiovascular disease.

At first glance, AKCEA-APOCIII-LRx looks the more effective. The highest dose studied, 50mg every four weeks, led to a 62% reduction in fasting triglycerides. Meanwhile, the best-performing dose of vupanorsen, 80mg every four weeks, lowered fasting triglycerides by 53%.

However, the AKCEA-APOCIII-LRx study enrolled a more severe patient population, making cross-trial comparisons tricky, Stifel analysts noted. Perhaps things will look clearer after later-stage trials: Akcea/Ionis – now again one company – plans to take AKCEA-APOCIII-LRx into a phase III trial in familial chylomicronemia syndrome, while Pfizer is set to start a phase IIb study of vupanorsen in the second half of this year.

Medtronic's frozen hearts 

Medtronic’s efforts to position its cryoabation technology as a first-line treatment for paroxysmal atrial fibrillation advanced a step with data from the Stop-AF First trial, presented on Saturday. This compared the use of the group's Arctic Front Advance cryoballoon – used to freeze heart tissue, creating scars that interrupt the overactive electrical pathways that cause intermittent arrhythmia – with antiarrhythmic drugs in 203 drug-naïve patients.  

Treatment success, defined as freedom at one year from atrial fibrillation, atrial tachycardia and atrial flutter, was achieved in 75% of patients who underwent pulmonary vein isolation with the cryoballoon versus 45% of those treated with drugs. This was statistically significant with a p value of less than 0.0001.  

The Arctic Front Advance is approved in the US but only for patients with drug-refractory, recurrent, symptomatic paroxysmal AF. The new data could expand its use; Medtronic will want to submit it to the FDA in short order.

Vantage’s ESC coverage

As for other ESC highlights, Vantage already reported that the benefit of the SGLT2 inhibitors is starting to look like a class effect. In the Emperor-Reduced trial, presented on Saturday, Lilly and Boehringer Ingelheim’s Jardiance showed a benefit uncannily similar to that seen with Astrazeneca’s Farxiga in Dapa-HF last year (ESC 2020 – Jardiance joins Farxiga in showing heart failure benefit, August 29, 2020).

Meanwhile, Myocardia presented full data from the pivotal Explorer-HCM trial of mavacamten, setting that project up for a regulatory nod in hypertrophic cardiomyopathy (ESC 2020 – Myokardia odds-on for first approval in heart muscle disease, August 29, 2020).

This year's virtual meeting, which was free to attend, had over 116,000 delegates – a huge increase on last year's 33,500 attendees. Perhaps whatever was lost in terms of face-to-face networking was offset by the sheer number of people able to watch the sessions. The future of medical meetings might well be digital, but conference organisers will have to find a way to recoup their costs.

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