ABIONYX Pharma has completed a successful pre-IND meeting with the FDA for CER-001 Phase 2b/3 Clinical Trial for Patients with Sepsis
June 13 2024 - 1:49PM
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
Access here the full press release
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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20240613794882/en/
Contacts: 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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