ABIONYX Pharma Acknowledges the Clinical Results of the Phase 3 AEGIS-II Study Evaluating the Efficacy and Safety of CSL Behring’s Human-plasma-derived apoA-I, CSL112
15 Februar 2024 - 6:00PM
Business Wire
Regulatory News:
ABIONYX Pharma, (FR0012616852 – ABNX – PEA PME
eligible), a new generation biotech company dedicated to the
discovery and development of innovative therapies based on the
world’s only natural recombinant apoA-I, today acknowledges that
the Phase 3 AEGIS-II study evaluating the efficacy and safety of
CSL Behring’s human-plasma-derived apoA-I, CSL112, compared to
placebo in reducing the risk of major adverse cardiovascular events
(MACE) in patients following an acute myocardial infarction (AMI),
did not meet its primary efficacy endpoint of MACE reduction at 90
days.
In addition, CSL Behring announced that there are no plans for a
near-term regulatory filing and added there were no major safety or
tolerability concerns with CSL112. With over 18,000 patients
treated, the AEGIS-II Trial results stand as a testament to the
safety and tolerability of apoA-1-based treatments.
The clinical results of the Phase 3 AEGIS-II Trial of human
plasma-derived apolipoprotein A-I, CSL112 in acute myocardial
infarction (AMI), strongly supports ABIONYX’ decision, made four
years ago, to reposition the development of CER-001 out of the
treatment of longstanding chronic diseases, such as coronary artery
disease, and into acute conditions where the short-term dosing
model followed by Abionyx has the potential to make a marked
impact. ABIONYX Pharma has meticulously evaluated other diseases
where apoA-I is known to have a beneficial or protective effect.
Acute sepsis is an example where the beneficial effects of apoA-1
on mortality and other outcomes is supported by a wealth of
epidemiological, genetic, animal and human data, including animal
and human data with CER-001.
Building on the safety demonstrated during CER-001 Phase 2 and 3
trials with 900 patients in cardiovascular diseases, Abionyx has
strategically redirected its focus towards addressing high levels
of unmet medical need in acute sepsis, acute renal, inflammatory
and ophthalmic diseases. This pivotal decision demonstrates
ABIONYX’ dedication to innovative treatments where therapy using
recombinant apoA-1 can maximize impact on patient outcomes.
About CER-001 CER-001 is a novel engineered recombinant
human apoA-I that was designed to mimic the structural and
functional biological properties of natural, nascent HDL, also
known as pre-β HDL, and has been shown to perform all steps of the
Reverse Lipid Transport pathway (RLT), the only natural pathway
responsible for lipid elimination.
Administered CER-001 particles increase transient apoA-I and the
number of HDL particles and promote the elimination of trapped
cholesterol and lipids in tissues in the absence of LCAT enzyme for
example, but also the elimination of bacterial lipid endotoxin
(LPS) in the case of sepsis. HDL particles are then recognized by
the liver, leading to the elimination of these transported lipids
via a process called Reverse Lipid Transport (RLT).
About ABIONYX Pharma ABIONYX Pharma is a next-generation
biotech company focused on developing innovative medicines in
diseases where there is no effective or existing treatment, even
the rarest ones. The company expedites the development of novel
therapeutics through an extensive expertise in lipid science and a
differentiated apoA-I -based technology platform. ABIONYX Pharma is
committed to radically improving treatment outcomes in sepsis and
critical care.
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version on businesswire.com: https://www.businesswire.com/news/home/20240215784707/en/
NewCap Investor relations Nicolas Fossiez Louis-Victor
Delouvrier abionyx@newcap.eu +33 (0)1 44 71 98 53
NewCap Media relations Arthur Rouillé abionyx@newcap.eu
+33 (0)1 44 71 00 15
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