Quantum Genomics Presents Results from Phase IIb QUORUM Study of Firibastat in Heart Failure at the European Society of Cardiology Meeting
August 27 2021 - 4:45AM
Quantum Genomics (Euronext Growth - FR0011648971 -
ALQGC), a biopharmaceutical company specializing in
developing a new drug class that directly targets the brain to
treat difficult-to-treat and resistant hypertension and heart
failure, today announced results of the Phase IIb QUORUM study were
presented by Prof. Gilles Montalescot (Paris) on August 27, 2021
during the 2021 scientific sessions of the European Society of
Cardiology (ESC).
“The QUORUM study demonstrates the efficacy and
good safety profile of firibastat. These good results will be
decisive for the signing of new partnerships and encouraging for
the continued advancement of firibastat in clinical trials",
declared Jean-Philippe Milon, CEO of Quantum Genomics.
"Today, based on the results of QUORUM, we know
that the effectiveness of firibastat on the entire study population
is of the same level as of the most effective molecule in post
myocardial infarction to date, ramipril,” said Dr. Bruno Besse,
Medical Director of Quantum Genomics. “In severe patients with an
ejection fraction less than 50%, firibastat appears to be more
effective than ramipril. On the other hand, QUORUM shows that
firibastat improves the blood pressure profile. Substantial
reduction of blood pressure with ACE inhibitors such as ramipril,
the reference treatment, is a limiting factor of current management
of severe patients. For this reason, QUORUM’s phase IIb results
pave the way for a phase III clinical study in severe patients
whose protocol will be finalized with a selected partner
pharmaceutical company.”
Highlights from the phase IIb QUORUM study are
included below:
Better efficacy of firibastat than
ramipril in severe patients295 patients were enrolled in
the study within 24 hours of a first myocardial infarction. After
12 weeks of treatment, the left ventricular ejection fraction
evaluated by cardiac MRI, increased from 53 to 59% in the
firibastat 100 mg twice daily group, from 51 to 58% in the
firibastat 500 mg twice daily group and 50 to 57% in the ramipril 5
mg twice daily control group; these strata encompassing the entire
study population. The difference between the 3 groups was not
statistically significant.
In the subgroup of severe patients with an
ejection fraction less than 50%, the ejection fraction increased by
5.32 ± 1.67% under firibastat 500 mg, and by 3.51 ± 1.64% under
ramipril.
Only firibastat improved the patients'
blood pressure profile, especially in severe patientsBlood
pressure did not limit increasing doses of firibastat to reach
the target dose, while 32.5% of patients failed to reach the target
dose with ramipril.
Good safety profileFiribastat
was safe and well tolerated. The most common side effects were skin
reactions, which occurred in 4% of cases with firibastat 100 mg
BID, 10% with firibastat 500 mg BID and 5% with ramipril (including
angioedema, a well-known potentially severe side effect of
ramipril). Renal impairment or hyperkalemia has not been observed
with firibastat.
Prof. Gilles Montalescot, principal investigator
of the study added: “The QUORUM study is a very important study,
being one of the rare studies conducted in post-infarction since
the advent of primary angioplasty, with a strict methodology
(randomized, double-blind, fractional ejection evaluated by cardiac
MRI with centralized reading). Firibastat has not been compared
with a placebo but with ramipril, which is the gold standard
treatment, and is very effective in this pathology. Even if in this
study, firibastat at two doses of 100 mg and 500 mg twice a day did
not demonstrate superiority over ramipril, having a new drug
class with good hemodynamic safety profile to treat severe patients
would be a real medical breakthrough. We can see that the maximum
dose was reached more easily and more frequently with firibastat
than with ramipril.”
About QUORUM QUORUM
(NCT03715998) is a phase IIb, European, multicenter, randomized,
double-blind study comparing the efficacy and safety of two doses
of firibastat with a reference treatment with ramipril, in the
prevention of left ventricular dysfunction after acute myocardial
infarction. 295 patients recruited within 24 hours after a first
prior myocardial infarction were randomized into 3 groups and
received for 12 weeks either firibastat 100 mg twice daily (after
two weeks at 50 mg twice daily) or firibastat 500 mg twice daily
(after two weeks at 250 mg twice daily) or standard treatment
(ramipril 5 mg twice daily after two weeks at 2.5 mg twice daily).
The primary outcome measure was the change from baseline in the
left ventricular ejection fraction, assessed by cardiac MRI
(centralized reading). Secondary endpoints were changes in other
MRI parameters, cardiovascular events, biomarkers, and clinical and
laboratory tolerance.
About Firibastat Firibastat is
the first drug candidate in a new class of therapeutic agents
called BAPAIs (Brain Aminopeptidase A Inhibitors). Firibastat is a
prodrug that releases EC33, a specific and selective inhibitor of
aminopeptidase A in the brain, thereby preventing the production of
angiotensin III in the brain.
About Quantum GenomicsQuantum
Genomics is a biopharmaceutical company specializing in the
development of a new class of cardiovascular medications based on
brain aminopeptidase A inhibition (BAPAI). Quantum Genomics is the
only company in the world exploring this innovative approach that
directly targets the brain. The company relies on 20 years of
academic research from the Paris-Descartes University and the
laboratory directed by Dr. Catherine Llorens-Cortes at the Collège
de France (French National Institute of Health and Medical Research
(INSERM)/ the Scientific Centre for National Research (CNRS)). The
goal of Quantum Genomics is to develop innovative treatments for
complicated, or even resistant, cases of hypertension (around 30%
of patients have poor control of their condition or receive
ineffective treatment) and for heart failure (one in two patients
diagnosed with severe heart failure dies within five years).
Based in Paris and New York, Quantum Genomics is
listed on the Euronext Growth exchange in Paris (FR0011648971-
ALQGC) and trades on the OTCQX Best Market in the United States
(symbol: QNNTF).
For more information, please visit
www.quantum-genomics.com, or follow us on Twitter and LinkedIn
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