The safety and effectiveness of nafamostat is
being assessed in the NEPHRO CRRT registrational trial in 166
patients at up to 14 clinical sites
Primary endpoint in the NEPHRO CRRT study is
measured over the first 24 hours, with patients completing the
study after 72 hours
Dr. Stuart
Goldstein, a world-renowned nephrologist, is the first
physician to enroll a patient in the NEPHRO CRRT
study
SAN
MATEO, Calif., Aug. 19,
2024 /PRNewswire/ -- Talphera, Inc. (Nasdaq: TLPH),
("Talphera"), a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for use
in medically supervised settings, today announced the first patient
has been enrolled in the NEPHRO CRRT study.
The NEPHRO CRRT registrational study will enroll 166 patients
undergoing continuous renal replacement therapy (CRRT) at up to 14
clinical sites across the United
States. The primary endpoint of the study is the mean
post-filter activated clotting time for circuits infused with
nafamostat versus placebo over the first 24 hours.
"We are excited to be able to offer participation in this
nafamostat study to our patients requiring CRRT,"
stated Stuart Goldstein, M.D., Professor of Pediatrics
and Director of the Center for Acute Care Nephrology at Cincinnati
Children's Hospital Medical Center. "Nafamostat, if approved
following this trial, will be a valuable addition to our
anticoagulant options for many patients."
"We are pleased the first patient was enrolled in the study last
week. Nafamostat has the potential to address disadvantages of the
currently available U.S. products used for anticoagulation of the
extracorporeal circuit. Enrolling the first patient in the NEPHRO
study is the first of what we believe will be several important
milestones for Talphera," stated Dr. Shakil
Aslam, Chief Development Officer at Talphera. "Nafamostat
has been used, and is a standard of care, in Japan and South
Korea for over 30 years and we're excited about the
prospects of making nafamostat available to healthcare providers in
the United States, if approved,"
continued Dr. Aslam.
About Niyad and nafamostat
Nafamostat is a broad spectrum, synthetic serine protease
inhibitor with anticoagulant, anti-inflammatory and potential
anti-viral activities. Niyad™ is a lyophilized formulation of
nafamostat and is currently being studied under an IDE, as an
anticoagulant for the extracorporeal circuit, and has received
Breakthrough Device Designation Status from the FDA. Talphera's
registrational study of Niyad™ is named the NEPHRO CRRT
(Nafamostat Efficacy in Phase 3
Registrational Continuous Renal
Replacement Therapy) study. An ICD-10 procedural
code, XY0YX37, has been issued for the extracorporeal
introduction of nafamostat. The ICD-10 code is a
specific/billable code that can be used to indicate a procedure.
LTX-608 is a proprietary nafamostat formulation for direct IV
infusion that may be investigated and developed for the treatment
of acute respiratory distress syndrome (ARDS), disseminated
intravascular coagulation (DIC), acute pancreatitis or as an
anti-viral treatment, amongst other potential targets.
About Talphera, Inc.
Talphera, Inc. is a specialty pharmaceutical company focused on
the development and commercialization of innovative therapies for
use in medically supervised settings. Talphera's lead product
candidate, Niyad™ is a lyophilized formulation of nafamostat and is
currently being studied under an investigational device exemption
(IDE) as an anticoagulant for the extracorporeal circuit, and has
received Breakthrough Device Designation status from the U.S. Food
and Drug Administration (FDA).
This release is intended for investors only. For additional
information about Talphera, please visit www.talphera.com.
About the NEPHRO CRRT Study
The NEPHRO Study, which has received central IRB approval, is
designed as a prospective, double-blinded trial to be conducted at
up to 14 U.S. hospital intensive care units. The study will enroll
and evaluate 166 adult patients undergoing renal replacement
therapy, who cannot tolerate heparin or are at risk for bleeding.
The primary endpoint of the study is mean post-filter activated
clotting time using Niyad versus placebo over the first 24 hours.
Key secondary endpoints include filter lifespan, number of filter
changes over 72 hours, number of transfusions over 72 hours and
dialysis efficacy (based on urea concentration) over the first 24
hours.
Forward-looking statements
This press release contains forward-looking statements based
upon Talphera's current expectations and assumptions. These and any
other forward-looking statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. These statements may be identified by the use of
forward-looking terminology such as "believe," "expect,"
"finalize," "may," "if," "intends," "plans," "potential,"
"projected," "will," or the negative of these words or other
comparable terminology, and include: Talphera's expectation that
the NEPHRO study will enroll and complete efficiently, the
potential of nafamostat to address unmet needs in anticoagulation
of the extracorporeal circuit, and the potential advantage of
having Breakthrough Device Designation and potential FDA approval
of the nafamostat product candidate. Talphera's discussion of its
strategy, plans and intentions also include forward-looking
statements, which are predictions, projections and other statements
about future events that are based on current expectations and
assumptions. These forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from those projected, anticipated or implied by such statements,
including: (i) risks relating to Talphera's product development
activities, including that clinical studies may not confirm any
safety, efficacy or other product characteristics described or
assumed in this press release; (ii) Talphera's developmental
product candidates may not be beneficial to patients or healthcare
providers or be successfully commercialized; (iii) risks relating
to Talphera's ability to obtain regulatory approvals for its
developmental product candidates; (iv) risks related to the ability
of Talphera and its business partners to implement development
plans, commercial launch plans, forecasts and other business
expectations; and (v) risks related to Talphera's liquidity and its
ability to maintain capital resources sufficient to conduct its
clinical studies. Although it is not possible to predict or
identify all such risks and uncertainties, they may include, but
are not limited to, those described under the caption "Risk
Factors" and elsewhere in Talphera's annual, quarterly and current
reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or
furnished with the SEC and any subsequent public filings. You are
cautioned not to place undue reliance on any such forward-looking
statements, which speak only as of the date such statements were
first made. To the degree financial information is included in this
press release, it is in summary form only and must be considered in
the context of the full details provided in Talphera's most recent
annual, quarterly or current report as filed or furnished with the
SEC. Talphera's SEC reports are available at www.talphera.com under
the "Investors" tab. Except to the extent required by law, Talphera
undertakes no obligation to publicly release the result of any
revisions to these forward-looking statements to reflect new
information, events or circumstances after the date hereof, or to
reflect the occurrence of unanticipated events.
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SOURCE Talphera, Inc.
