- Sepsis, the world's 3rd leading cause of death, is
exacerbated by the spread of bacterial infections due to global
warming and an aging population
- No effective treatment specific to sepsis is available to
date
- ABIONYX's innovative approach restores apoA-1 protein levels
in the human body to eliminate endotoxins, enabling patients to
fight sepsis more effectively
- Positive clinical results from the Phase 2a RACERS study for
the treatment of sepsis will be detailed in a scientific paper to
be published by the end of 2023
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-1, reports on its commitment
and strategic analysis for the development of its innovative
breakthrough treatment on World Sepsis Day.
Sepsis, the world's 3rd leading cause of death, is
exacerbated by the spread of bacterial infections due to global
warming and an aging population
Sepsis is already the 3rd leading cause of death worldwide.
Added to this are a number of factors that are likely to exacerbate
the spread of sepsis in the years to come. It is widely recognized
that bacterial infections will increase as a result of global
warming. 2023 saw the accelerated development of potentially deadly
bacteria which proliferate in the world's oceans as a result of
warmer waters due to climate change, according to a study published
in the journal Scientific Reports on March 23, 2023.
Current climatic trends are increasing the spread of
drug-resistant infectious diseases. Intensive antimicrobial use
worldwide is exacerbating this pattern of resistance. Combined with
the aging of the world's population, which naturally weakens the
human immune system, resistance to antibiotics an important
adjunctive treatment for sepsis - will lead to an increase in
sepsis cases worldwide. All in all, the number of fatal cases is
set to double over the next fifty years, with nearly 14 million
deaths a year in 2019 (The Lancet study, 2022).
No effective sepsis treatment option available to
date
For over twenty years, and despite considerable progress in
understanding the pathophysiology associated with sepsis, no new
therapies specific to this disease have emerged. Patients with
sepsis are generally admitted to intensive care units, where they
receive antibiotics and life-support. However, with increasing
antibiotic resistance (or AMR for AntiMicrobial Resistance), which
renders one or more antibiotics ineffective against a bacterial
infection, the phenomenon can lead to sepsis becoming
untreatable.
A new approach, through the restoration of apoA-1 protein
levels in the human body, to eliminate inflammation-causing
endotoxins and enable patients to fight sepsis
ABIONYX Pharma is developing a new approach to the treatment of
sepsis that goes beyond previous approaches. In fact, the Company
is developing and producing a biological drug consisting of a
recombinant replica of one of the most abundant natural proteins in
human plasma, apoA-1. This protein enables the elimination of
endotoxins, components of bacterial walls, which are responsible
for the toxic effects triggered by severe bacterial infections.
In fact, when apoA-1 levels fall in the human body in fragile or
weakened patients, the immune system is less able to naturally
eliminate the endotoxins present following a bacterial infection.
ABIONYX Pharma, the only biotech capable of developing and
producing recombinant apoA-1, proposes to supplement and restore
the human body's apoA-1 levels according to the patient's specific
needs, so that endotoxins present in the body can be eliminated,
allowing antibiotics to play their full role in destroying infected
bacteria.
Positive clinical results in the 2a RACERS study for the
treatment of sepsis, which will be detailed in a scientific paper
to be published by the end of 2023
ABIONYX Pharma is developing a phospholipid-complexed
recombinant apoA-1 called CER-001. The efficacy of this recombinant
apoA-1 was demonstrated in a Phase 2a clinical trial, called
RACERS, in septic patients at high risk of developing acute kidney
injury.
The clinical results of RACERS, a study led by Professor Loreto
Gesualdo and his research team from the Department of Nephrology at
the University of Bari, Italy, demonstrate for the first time in a
human trial that restoration of normal apoA-1 levels by CER-001
infusion induces a rapid and sustained reduction in endotoxin
levels, as well as a consequent reduction in the inflammatory
cascade caused by sepsis, compared with standard reference
treatment alone. The reduction in the number of days spent in the
intensive care unit for patients treated with the CER-001 biologic,
and the improvement in thirty-day survival, will be detailed in
figures in a publication in a scientific journal to be published by
the end of 2023.
About sepsis/septicemia
Sepsis is the Anglo-Saxon and international term used to
characterize a generalized inflammatory response associated with
severe infection. The term septicemia, coined in 1837 by French
physician Pierre Piorry from the Greek words "Σήψις" (sêptikós),
putrefaction, and "αίμα" (haîma), blood, refers to the presence of
bacteria (or even fungi or viruses) in the blood. Sepsis mainly
affects already-weakened individuals, newborns and the elderly, but
can also affect people with no prior ailment. Worldwide, an
estimated 11 million people die each year from sepsis. Future
projections suggest a doubling in the number of cases over the next
fifty years, particularly as the population ages.
About RACERS
RACERS is a clinical trial named RACERS (a RAndomized study
comparing short-term CER-001 infusions at different doses to
prevent Sepsis-induced acute kidney injury) with CER-001 in septic
patients at high risk of developing acute kidney injury.
Following the positive signals observed in the Temporary
Authorization for Named Use (ATUn) in an ultra-rare kidney disease,
the study assessed the role of CER-001, a novel, in preventing
Acute Kidney Injury (AKI) in septic patients. The core component of
the program is the launch of a 30-day Phase 2a clinical
dose-finding trial with the Company's lead product candidate,
CER-001, in the prevention of AKI in septic patients. Researchers
have demonstrated that in humans, reconstituted HDLs have a
scavenger role in reducing circulating endotoxin, as well as major
anti-inflammatory and endothelial activity. These important effects
were also demonstrated with CER-001 in a rigorous preclinical model
of sepsis-induced AKI developed in collaboration with an Italian
Veterinarian Hospital (Surgical Section, Chief: Prof. Antonio
Crovace). Several other AKI/sepsis models showed that HDL is a
critical factor in modifying the disease.
This clinical study, designed in concert with expert Italian
nephrologists (Nephrology, Dialysis and Transplantation Unit,
Chief: Prof. Loreto Gesualdo) and intensivists (Anesthesiology and
Resuscitation Unit, Chief: Prof. Salvatore Grasso), was a
randomized, open labelled, placebo-controlled, parallel-group study
evaluating the safety and efficacy of intravenously administered
CER-001 in patients with sepsis at high risk for AKI based on their
endotoxin levels and Sequential Organ Failure Assessment (SOFA
score). A total of 20 patients were randomized to receive 8 doses
of CER-001 over 6 days on top of standard of care, or standard of
care alone. The primary endpoint of the study was the onset and
severity of AKI according to KDIGO criteria as well as safety and
tolerability of the dosage regimens in order to select the optimal
dose of CER-001.
The clinical study was partnered with the University of
Bari.
About ABIONYX Pharma
ABIONYX Pharma is a new generation biotech company that aims to
contribute to health through innovative therapies in indications
where there is no effective or existing treatment, even the rarest
ones. Thanks to its partners in research, medicine,
biopharmaceuticals and shareholding, the company innovates on a
daily basis to propose drugs for the treatment of renal and
ophthalmological diseases, or new HDL vectors used for targeted
drug delivery.
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version on businesswire.com: https://www.businesswire.com/news/home/20230912143421/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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