DJ Atox Bio announces FDA acceptance of New Drug Application
Arix Bioscience PLC (ARIX)
Atox Bio announces FDA acceptance of New Drug Application
11-Dec-2020 / 07:00 GMT/BST
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Arix Bioscience plc
Atox Bio announces FDA acceptance of New Drug Application
? Necrotizing soft tissue infection (NSTI) is a rare, life-threatening
disease that involves significant necrosis and tissue destruction coupled
with systemic organ failure
? Reltecimod marketing authorisation by the FDA would provide physicians
with the first therapy to treat suspected organ dysfunction or failure in
patients with NSTI
? FDA sets PDUFA date for 30 September 2021
LONDON, 11 December 2020: Arix Bioscience plc ("Arix", LSE: ARIX) a global
venture capital company focused on investing in and building breakthrough
biotech companies, notes that its portfolio company Atox Bio, announced that
the U.S. Food and Drug Administration (FDA) has accepted its New Drug
Application (NDA) for reltecimod. The proposed indication is for the
treatment of suspected organ dysfunction or failure in patients with NSTI in
conjunction with surgical debridement, antibiotic therapy, and supportive
care.
The Prescription Drug User Fee Act (PDUFA) date set by the FDA, which is the
goal date for a decision on the NDA, is 30 September 2021.
Jonathan Tobin, Managing Director at Arix and Board Director at Atox Bio,
commented:
"The NDA acceptance marks an important step forward in Atox Bio's
development of reltecimod for patients with NSTI, a devastating and
potentially fatal disease for which there is no approved treatment."
The announcement can be accessed on Atox Bio's website at
https://www.atoxbio.com/news/ [1] and full text of the announcement from
Atox Bio is contained below.
[ENDS]
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About Arix Bioscience plc
Arix Bioscience plc is a global venture capital company focused on investing
in and building breakthrough biotech companies around cutting-edge advances
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the capital, expertise and global networks to help accelerate their ideas
into important new treatments for patients. As a listed company, we are able
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www.arixbioscience.com [2]
Atox Bio Announces FDA Acceptance to File the NDA for Reltecimod to Treat
Suspected Organ Dysfunction or Failure in Patients with Necrotizing Soft
Tissue Infection("Flesh-Eating Disease")
- PDUFA Date of September 30, 2021 -
- NDA Filed Under FDA Accelerated Approval Program -
? Necrotizing soft tissue infection (NSTI) is a rare, life-threatening
disease that involves significant necrosis and tissue destruction coupled
with systemic organ failure
? If approved, reltecimod would be the first therapy to treat suspected
organ dysfunction or failure in patients with NSTI
Durham, NC and Ness Ziona, Israel - December 10, 2020 - Atox Bio [3] today
announced that the U.S. Food and Drug Administration (FDA) has accepted to
file the New Drug Application (NDA) for reltecimod with a Prescription Drug
User Fee Act (PDUFA) date of September 30, 2021. The proposed indication is
for the treatment of suspected organ dysfunction or failure in patients >=12
years of age with NSTI, in conjunction with surgical debridement, antibiotic
therapy, and supportive care. If approved, reltecimod could advance the
standard of care for patients with NSTI by providing a novel treatment
option for these patients.
"The FDA's decision to file the NDA for reltecimod marks another important
step forward for Atox Bio in potentially bringing this innovative therapy to
patients with NSTI," said Dan Teleman, CEO of Atox Bio. "The development of
reltecimod reinforces Atox Bio's expertise in immunotherapy, our deep
understanding of unmet needs in the critical care setting, and commitment to
improving clinical outcomes for patients affected by this rare,
life-threatening disease."
Based on discussions with FDA, Atox Bio submitted an NDA under the
Accelerated Approval Program. The Company believes reltecimod meets
Accelerated Approval criteria as it treats a serious condition, provides
meaningful therapeutic benefit over existing treatments, and demonstrates an
effect on an intermediate clinical endpoint; resolution of organ
dysfunction, that is reasonably likely to predict the clinical benefit of
improved long-term survival.
Results from the ACCUTE study were previously announced here [4].
About Reltecimod
Reltecimod is a small synthetic peptide that is host-oriented and
pathogen-agnostic. With its novel mechanism of action, reltecimod leads to
resolution of organ dysfunction or failure by attenuating the dysregulated
immune response frequently seen in patients with NSTI. It binds to the dimer
interface of CD28 expressed on T-cells, thereby modulating the acute
inflammation that leads to systemic organ failure. By acting on this early
step in the host immune response, reltecimod avoids the ongoing concerns
about bacterial resistance and is active independent of the pathogen type.
FDA granted reltecimod Fast Track status and orphan drug designation for
NSTI. The European Commission granted orphan designation for reltecimod in
the treatment of NSTI.
About Necrotizing Soft Tissue Infections (NSTI)
NSTI, commonly referred to as "flesh-eating disease" or "flesh-eating
bacteria" is a rare, life-threatening disease that can travel quickly from
the infection site and requires frequent, rapid surgical intervention to
remove dead and infected tissue to stop further progression and the need for
amputation. By their nature, these surgeries often leave patients
significantly disfigured. In more serious cases, acute inflammation that
results from the infection leads to systemic organ dysfunction in the heart,
lungs and/or kidneys. Even with the best current standard of care that
includes surgical debridement, broad spectrum antibiotics, and supportive
intensive care, multi-organ failure frequently occurs. Mortality rates are
significant in both the short- and intermediate-term, and patients who do
survive often face long and expensive hospital and rehabilitation center
stays.
Hospital discharge data indicate there are approximately 30,000 cases of
NSTI in the US each year, with a similar number in Europe. There are
currently no therapies specifically approved for NSTI.
About ACCUTE
ACCUTE (AB103 Clinical Composite endpoint StUdy in Necrotizing Soft Tissue
infEctions) was a Phase 3 randomized, placebo-controlled study that enrolled
290 patients across sites in the US and France. It evaluated the safety and
efficacy of a single dose of intravenous reltecimod 0.5mg/kg versus placebo
(0.9% saline) administered in conjunction with surgical debridement (removal
of damaged skin, subcutaneous tissue, fascia, and sometimes muscle),
antibiotic therapy, and supportive care in patients >=12 years of age with
NSTI. The trial also assessed hospital discharge status and impact on
healthcare resource utilization.
About Atox Bio
Atox Bio is a late stage clinical company that develops immunotherapies for
critically ill patients. The ACCUTE study was funded in whole or in part
with Federal funds from the Department of Health and Human Services; Office
of the Assistant Secretary for Preparedness and Response; Biomedical
Advanced Research and Development Authority (BARDA), under Contract No.
HHSO100201400013C. 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. Please visit www.AtoxBio.com [3]
for more information.
Media Contact:
Julia Wilson
JW Communications
juliawilsonuk@gmail.com
+44 781 8430877
December 11, 2020 02:00 ET (07:00 GMT)
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