SOUTH SAN FRANCISCO, Calif.,
June 23, 2021 /PRNewswire/
-- Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) today announced
that the in vivo study of its human kappa-opioid receptor agonist
("TP-2021," formerly JT-09) ProNeura®-based implant in an
established 5'-guanidinonaltrindole (5'-GNTI) itch-induced mouse
model, has demonstrated the potential to provide extended efficacy
and durability in the treatment of moderate-to-severe chronic
pruritus (itch).
As previously reported, subcutaneously injected (0.3mg/kg)
TP-2021 was compared to difelikefalin (KorsuvaTM, which
is in late-stage development by Cara Therapeutics, Inc. across
multiple indications, including intravenous treatment of
hemodialysis patients with chronic pruritus), and was observed to
be equally potent in reducing scratching and grooming behaviors in
this established animal itch model, in studies conducted in
collaboration with Charles Chavkin,
Ph.D., the Allan and Phyllis Treuer Endowed Chair of Pain Research
and Professor, Department of Pharmacology, at the University of Washington Health Sciences Center,
Seattle, WA.
Based on the positive data with subcutaneous injection of
TP-2021 and the selective binding exhibited by TP-2021 at the kappa
opioid receptor, Titan tested ProNeura-based TP-2021 implants in an
initial study, also conducted in collaboration with Dr. Chavkin.
Following implantation of one TP-2021 prototype implant, the
treated and untreated control mice were repeatedly challenged with
5'-GNTI. The results from these studies demonstrated that the
experimental TP-2021 implants provided sustained itch suppression
for a period of 14 days post-implantation. In addition, mice were
sampled for pharmacokinetic analysis following subcutaneous acute
injection with TP-2021 (0.3 mg/Kg) in saline or following
implantation with one TP-2021 implant. The results indicate that
the mouse implant provided sustained plasma concentrations of
TP-2021 that were well above the levels observed to provide
therapeutic anti-pruritus activity after acute administration. This
is a clear early demonstration of the potential of TP-2021 implants
for long-term treatment of pruritus, and of Titan's proprietary
ProNeura implant platform to provide in-vivo long-term delivery of
peptides at biologically-active concentrations.
"Chronic pruritus is a debilitating condition with no
satisfactory medical treatment available today, and the recent
advances with kappa opioid receptor agonist treatments are very
promising,' said Dr. Chavkin. "The results of these nonclinical
studies with TP-2021 implants are very encouraging, and indicate
that sustained delivery of kappa opioid receptor agonists should be
able to provide long-term anti-pruritus benefits in humans. The
concept of long-term treatment using implants can potentially
provide an important breakthrough, with continuous delivery of
therapeutic blood levels of medication, potentially avoiding the
need for frequent IV administration."
"TP-2021 is a small peptide, and the sustained delivery and
associated biological activity of peptides has historically been
difficult to attain beyond several hours after administration,
typically due to enzymatic degradation in the blood," said
Kate Beebe DeVarney, Ph.D.,
President and Chief Operating Officer of Titan. "Having established
that ProNeura-based prototype implants can provide continuous
delivery of TP-2021 in this murine efficacy model, we will now
fine-tune and optimize the TP-2021 implant to show significantly
longer duration of release in larger animal models. This will
further support the capability of attaining substantially
longer target plasma levels in humans, with the goal of delivering
efficacious therapy for six months or longer following a single
subdermal implantation. We have extensive prior experience with
this process, and believe we have the necessary proprietary
know-how to manufacture cGMP quality implants required to complete
the requisite nonclinical safety and pharmacology studies that will
allow filing of an Investigational New Drug (IND) application for
human clinical development of this novel treatment."
Marc Rubin, M.D. Titan's
Executive Chairman, added, "At Titan we have successfully returned
our focus to product development, our true and proven core
competency. Importantly, in addition to our progress on TP-2021 and
on the nalmefene implant development program for Opioid Use
Disorder, which is supported by a grant from the National Institute
on Drug Abuse, we have confidence that the ProNeura platform has
the potential for application in a number of additional settings,
and we look forward to future partnering opportunities in order to
further expand Titan's product development pipeline."
About Chronic Pruritus
Chronic pruritus is an unpleasant and often debilitating
condition, resulting in the need to scratch that lasts more than
6 weeks. It is a prevalent and bothersome symptom associated
with both cutaneous and systemic conditions. Due to its complex
pathogenesis and numerous contributing factors, effective treatment
of chronic pruritus therapy remains challenging.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) is a
development-stage biotechnology company developing proprietary
therapeutics using its clinically proven ProNeura® long-term,
continuous drug delivery technology. The ProNeura technology has
the potential to be used in developing products for treating
a number of chronic conditions where maintaining consistent,
around-the-clock blood levels of medication may benefit the patient
and improve medical outcomes. For more information about Titan,
please visit www.titanpharm.com.
Forward-Looking Statements
This press release may contain "forward-looking statements"
within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such statements
include, but are not limited to, any statements relating to our
product development programs and any other statements that are not
historical facts. Such statements involve risks and uncertainties
that could negatively affect our business, operating results,
financial condition and stock price. Factors that could cause
actual results to differ materially from management's current
expectations include those risks and uncertainties relating to our
ability to raise capital, the completion of final steps in the
winding down of U.S. commercial activities related to Probuphine,
the regulatory approval process, the development, testing,
production and marketing of our drug candidates, patent and
intellectual property matters and strategic agreements and
relationships. We expressly disclaim any obligation or undertaking
to release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in our
expectations or any changes in events, conditions or circumstances
on which any such statement is based, except as required by
law.
Korsuva is a trademark of Cara Therapeutics, Inc.
CONTACT:
Stephen Kilmer
Investor Relations
(650) 989-2215
skilmer@titanpharm.com
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SOURCE Titan Pharmaceuticals, Inc.