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 Having done well with recently launched drugs such as stroke
prevention pill Xarelto and eye treatment Eylea, the German company
is eager to show it has another potential billion-dollar-plus winner
in heart drug finerenone.
Finerenone, which is still several years from reaching the market,
is an improved version of a troublesome class of heart drugs called
mineralocorticoid receptor antagonists (MRAs).
Existing MRAs spironolactone and eplerenone, branded as Inspra by
Pfizer, are unsuitable for many patients since they can cause
abnormally high levels of potassium in the
blood, leading to irregular heart beat or even cardiac arrest.
The two older medicines, whose patents have expired, are also linked
to kidney problems.
Bayer's pill, however, works in a different way and appears to avoid
these issues, so cardiologists are watching its development closely.
"If you can eliminate hyperkalaemia (high potassium) that would be a
huge benefit to patients," said Mary Norine Walsh, vice president of
the American College of Cardiology, who was not involved in the
research.
Phase II trial data presented in London on Monday showed finerenone
led to fewer deaths and hospital admissions among participants
during 90 days of initial treatment, when compared to a control
group on eplerenone.
"We were somewhat surprised by this striking reduction in CV
(cardiovascular) events," Gerasimos Filippatos, the study's
principal investigator, told the European Society of Cardiology's
annual meeting.
LARGER TESTS NEEDED
The greatest relative risk reduction of 44 percent was seen in
patients who started at 10 mg daily of finerenone, which Filippatos
said appears to be the optimal dose.
"We didn't expect to see these clearly better results already in
Phase II," said Frank Misselwitz, head of the therapeutic area
cardiovascular and coagulation at Bayer.
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Larger tests are now needed to confirm the benefit.
A blood reading to measure stress on the heart, which was the
trial's primary efficacy measure, was at levels comparable to the
control group, as was the level of overall side effects.
Bayer will enroll more than 3,600 patients with heart failure and
diabetes and/or kidney disease in its final-stage Phase III study.
It has said previously it would also start even bigger Phase III
tests of the drug in diabetic kidney disease.
There has been little progress for more than a decade in treating
heart failure where the heart fails to pump enough blood around the
body, but competition is starting to heat up.
Novartis recently won approval for its drug Entresto that can cut
the risk of cardiovascular death and hospital admissions by a fifth,
and which is forecast by analysts to generate annual sales of more
than $5 billion by 2020.
Finerenone may only reach the market in 2020 or 2021, according to
analysts, leaving its prospects uncertain, although Berenberg and
Deutsche Bank have penciled in potential sales of $1.8 billion and
$2.0 billion respectively.
(Editing by William Hardy and David Clarke)
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