ABIONYX Pharma has completed a successful pre-IND meeting with the FDA for CER-001 Phase 2b/3 Clinical Trial for Patients with Sepsis
13 Junio 2024 - 12:48PM
Business Wire
- Based on encouraging Phase 2a data and a productive pre-IND
Type B meeting with U.S. Food and Drug Administration (FDA),
ABIONYX Pharma intends to file an Investigational New Drug
application (IND) in the coming months which will include a Phase
2b/3 clinical trial for CER-001 in Sepsis
Regulatory News:
ABIONYX Pharma, (FR0012616852 - ABNX - eligible for PEA
PME), 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 announced that the
company has completed a pre-IND (Investigational New Drug
Application, IND) meeting with the US Food and Drug Administration
and has received feedback to support an IND filing for its
candidate drug. This is an important validation of the quality of
the project and a significant step towards an application to
include American study centers in future clinical trials. ABIONYX
Pharma intends to file an IND application to the US authority in
the coming months.
Our latest phase 2a clinical study with CER-001, was published
by BMC Medicine, in a translational research paper that included
important in-vitro data, proof of concept in a pig model of sepsis
and a four-arm controlled study in patients with sepsis. All sets
of data showed statistically significant effects on parameters such
as endotoxin levels, key inflammatory cytokines such as IL-6 and
TNF-α and endothelial markers of inflammation such as sVCAM-1,
sICAM-1 and MCP-1.
“The positive pre-IND meeting with the FDA reflects the quality
and strength of the combined preclinical and clinical generated so
far during the development of CER-001. We appreciate the FDA's
guidance as we prepare to advance our novel therapy into phase
2b/3", said Dr. Rob Scott, Head of R&D and CMO at ABIONYX
Pharma. "The successful completion of this pre-IND engagement
is an important milestone that provides much regulatory clarity for
the future path forward for CER-001. Based on the wealth of
scientific evidence for the role of apoA-I in sepsis produced by us
and others, including compelling genetic validation, we believe our
recombinant apoA-I has potential to change the outcomes for
patients with sepsis. We are now eager to move ahead in the future
clinical development phases”.
About Sepsis
Sepsis is defined as life-threatening organ dysfunction caused
by a dysregulated host response to infection. Sepsis affects an
estimated 49 million people worldwide each year, including more
than 20 million children under age 5, and 1.7 million people in the
U.S alone. It is a leading cause of mortality worldwide and causes
more than 350,000 deaths per year in the U.S., which makes it the
third leading cause of overall mortality and the leading cause of
in-hospital death. Sepsis causes more deaths than chronic lower
respiratory diseases, stroke, Alzheimer’s disease, diabetes, or
accidental death. Sepsis is also the most expensive in-hospital
condition in the U.S., costing an estimated $62 billion each year,
counting just acute in-hospital care and skilled nursing costs.
There are no approved treatments that specifically target sepsis
and current management relies on anti-microbial therapy and
supportive care. Without any approved therapies for sepsis, the
global sepsis market size is still estimated to reach $7 billion in
2030 and grow at a compound annual growth rate of 5.6% between 2024
to 2030.
About CER-001
CER-001 is an engineered pre-β HDL particle which contains
recombinant human apolipoprotein A-I (apoA-I), complexed with
phospholipids. Pre-β HDL particles have been shown to be highly
effective scavengers of bacterial endotoxins, thereby inactivating
lipopolysaccharide (LPS) for removal by the liver.
About ABIONYX Pharma
ABIONYX Pharma is a next-generation biotech company focused on
developing innovative medicines for 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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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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