CHAPEL HILL, North Carolina and
NESS ZIONA, Israel, September 25, 2018 /PRNewswire/ --
Atox Bio, a clinical stage biotechnology company developing
novel therapies for critically ill patients, today announced the
independent Data Monitoring Committee (DMC) completed its
pre-planned safety review of the first 200 patients enrolled in the
company's ACCUTE trial and recommended that the study, evaluating
novel candidate Reltecimod for the treatment of Necrotizing Soft
Tissue Infections ("Flesh Eating Bacteria"), continue without
modification through completion.
We appreciated our interaction with the DMC and are pleased that
they have recommended the ACCUTE study continue as designed," said
Dr. Wayne Dankner, Chief Medical
Officer of Atox Bio. "A treatment is needed for this devastating
condition and we are hopeful that Reltecimod will be the first
product specifically approved for NSTI. We are continuing to enroll
patients in this Phase 3 study at multiple centers throughout the
U.S and France and look forward to
completing the study in 2019."
A DMC is a committee of independent clinical research experts
who review data in ongoing clinical trials with particular
attention to safety. As per the ACCUTE study protocol, the DMC
reviews are designed to examine the safety data accumulated during
the trial after patients have completed 28 days of study
follow-up.
In parallel, Atox Bio is conducting the REAKT Phase 2 study
evaluating Reltecimod in patients with Abdominal sepsis induced
Acute Kidney Injury.
About Reltecimod
Reltecimod (AB103) is a rationally designed peptide that binds
to the CD28 co-stimulatory receptor and restores the host's
appropriate immune response to severe infections. By modulating,
but not inhibiting, the body's acute inflammatory response,
Reltecimod is designed to help control the cytokine storm that
could otherwise quickly lead to morbidity and mortality. Reltecimod
received Orphan Drug status from the FDA and EMA as well as Fast
Track designation for the NSTI indication.
About Necrotizing Soft Tissue Infections
(NSTI)
NSTI, commonly referred to as "flesh eating bacteria", represent
the most severe types of infections involving soft tissues. NSTI
progress rapidly and often result in significant tissue destruction
and systemic disease leading to multiple organ failure and death.
NSTI are rare with approximately 28,000 patients annually in the
US. Currently, there are no approved treatments for NSTI. The
standard of care includes prompt and repeated surgical debridement,
aggressive resuscitation and physiologic support, in addition to
antibiotics.
About ACCUTE
The phase 3 ACCUTE (AB103 Clinical Composite endpoint Study in
necrotizing soft Tissue infections) study is an ongoing randomized,
placebo-controlled study, that plans to enroll 290 patients with
NSTI at approximately 70 level 1 trauma sites in the US. Patients
receive Reltecimod or placebo, administered as a single dose during
or shortly after surgical debridement, in addition to standard of
care treatment. The primary end point is a clinical composite that
evaluates both the local and systemic components of this
disease.
About Acute Kidney
Injury (AKI)
Acute Kidney Injury (AKI) involves inflammatory processes in the
kidney which can lead to permanent reduction of kidney function and
is also associated with an increased risk of death, extended
hospitalization, and increased medical cost. There are currently no
approved therapies to treat AKI and the only treatment options are
dialysis and supportive care.
About Atox Bio
Atox Bio is a late stage clinical biotechnology company that
develops novel immune modulators for critically ill patients with
severe infections. Atox Bio has an ongoing contract with the
Biomedical Advanced Research and Development Authority (BARDA)
supporting the development of Reltecimod in NSTI. Major investors
in the company include SR One, OrbiMed, Lundbeckfonden Ventures,
Arix Bioscience plc and Adams Street Partners. The Company was
established by Prof. Raymond
Kaempfer and Dr. Gila Arad from the Hebrew University of Jerusalem and Yissum. For
additional information http://www.atoxbio.com/
Media Contact:
Tsipi Haitovsky
Global Media Liaison
Atox Bio
+972-52-598-9892
Tsipihai5@gmail.com
SOURCE Atox Bio