TLC Announces Full Patient Enrollment in EXCELLENCE Trial of TLC599 for Osteoarthritis Pain
28 Dezembro 2020 - 6:00AM
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty
pharmaceutical company developing novel nanomedicines to target
areas of unmet medical need, announced today that patient
enrollment of EXCELLENCE, the Phase III pivotal clinical trial for
TLC599 in patients with osteoarthritis (OA) knee pain, has been
completed. TLC599 is a non-opioid, proprietary BioSeizer® sustained
release formulation of dexamethasone sodium phosphate (DSP)
intended to manage OA pain for up to six months.
“We are thrilled about the on-time completion of
patient enrollment despite the slight hindrance caused by COVID-19
earlier on in the year. In these unprecedented times, we are
especially grateful for the dedication of our research site staff
and trial participants, whose commitment to EXCELLENCE facilitated
the advancement of our lead program,” said George Yeh, President of
TLC. “We will continue to monitor each patient closely as they
receive the second injection. We believe that TLC599 has
significant potential to benefit patients suffering from the agony
of chronic OA pain while diminishing the need for opioids and the
chances of becoming addicted to these dangerous substances. We
remain confident that results from this trial will be positive
given the outstanding results observed in our Phase II clinical
trial.”
In the Phase II, randomized, double-blinded,
placebo-controlled clinical trial in patients with OA of the knee,
TLC599 demonstrated statistically significant and clinically
meaningful improvement in pain relief in both the Western Ontario
and McMaster Universities Osteoarthritis Index (WOMAC) and Visual
Analog Scale (VAS) scores compared to placebo from Day 3 all the
way through the end of the study at 24 weeks. Magnetic resonance
imaging (MRI) evaluation of knee cartilage using the MRI
Osteoarthritis Knee Score (MOAKS) instrument indicated that,
comparing index to non-index knees, patients treated with TLC599
displayed relatively less cartilage loss than patients treated with
placebo, suggesting there may be protection from cartilage
degeneration by TLC599. The pattern of efficacy seen in the overall
population was remarkably consistent between the various subgroups,
which were categorized based on gender, age, Kellgren-Lawrence
Grade, unilateral or bilateral pain, baseline VAS and WOMAC pain
scores, and further confirm the potential therapeutic effects of
TLC599.
EXCELLENCE, the Phase III, multi-center,
randomized, double-blind, placebo- and active comparator-controlled
pivotal study, is evaluating the efficacy and safety of a single as
well as a repeat dose of TLC599 12mg in approximately 500 patients
with knee OA across 46 sites in the US and Australia.
According to the US Department of Health and
Human Services, 10.3 million people misused prescription opioids in
2018, and many die every day from opioid-related drug overdoses.
The US Department of Justice announced in October that opioid maker
Purdue Pharma would plead guilty to fueling the nation’s opioid
crisis in a $8 billion settlement, and sued Walmart recently for
unlawfully dispensing controlled substances through its pharmacies,
certifying the gravity of the opioid crisis.
About TLC599
Current intraarticular anti-inflammatory
treatments for OA have potentially toxic side effects and may lead
to the destruction of cartilage filler proteins. An in vivo
toxicity study by staining of the cartilage showed TLC599 to be
cartilage sparing compared to current treatments. In a Phase II
clinical trial, a single injection of TLC599 resulted in
statistically significant and clinically meaningful improvement in
pain relief in both WOMAC and VAS scores over placebo for 24 weeks.
Over half of the patients in the TLC599 group had a durable
response, maintaining at least 30% pain reduction in both WOMAC and
VAS pain scores at all visits through the 24 weeks. EXCELLENCE, a
pivotal Phase III clinical trial to evaluate the efficacy and
safety of both single and repeated doses of TLC599, is ongoing.
About TLC
TLC (NASDAQ: TLC, TWO: 4152) is a
clinical-stage, specialty pharmaceutical company dedicated to the
research and development of novel nanomedicines that maximize the
potential of its proprietary lipid-assembled drug delivery platform
(LipAD™), including BioSeizer® sustained release technology and
NanoX™ active drug loading technology, which are versatile in the
choice of active pharmaceutical ingredients and scalable in
manufacturing. TLC has a diverse, wholly owned portfolio of
therapeutics targeting areas of unmet medical need in pain
management, ophthalmology, oncology and infectious diseases. TLC is
consistently ranked top 5% among all listed companies in Taiwan’s
Corporate Governance Evaluations.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Forward-looking statements contained in this
press release include, without limitation, statements regarding
TLC’s expectations regarding the clinical development of TLC’s
product candidates, including TLC599, the clinical benefits of
TLC’s product candidates, the timing, scope, progress and outcome
of TLC’s clinical trials, how sufficient cash and equivalents will
be to fund operations, the anticipated timelines for the release of
clinical data and progress of TLC’s manufacturing capabilities.
Words such as "may," "believe," "will," "expect," "plan,"
"anticipate," "estimate," "intend" and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are not guarantees of
future performance and involve a number of risks, assumptions,
uncertainties and factors, including risks that the outcome of any
clinical trial is inherently uncertain and product candidates may
prove to be unsafe or ineffective, or may not achieve commercial
approval, and delays or disruptions on our business or clinical
trials due to the COVID-19 pandemic. Other risks are described in
the Risk Factors section of TLC's annual report on Form 20-F for
the year ended December 31, 2019 filed with the U.S. Securities and
Exchange Commission (the “SEC”) as well as subsequent filings with
the SEC. All forward-looking statements are based on TLC's
expectations and assumptions as of the date of this press release.
Actual results may differ materially from these forward-looking
statements. Except as required by law, TLC expressly disclaims any
responsibility to update any forward-looking statement contained
herein, whether as a result of new information, future events or
otherwise.
TLC Contact:
Dawn Chi
Corporate Communications
dawn@tlcbio.com
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