TLC to Present Phase 3 Data of TLC599 in Late-Breaking Abstracts Session at ACR
November 08 2023 - 4:54AM
TLC BioSciences (TLC), a late clinical-stage specialty
pharmaceutical company developing novel nanomedicines to target
areas of unmet medical needs in orthopedic disorders, today
announced that the Abstract Selection Committee of the American
College of Rheumatology (ACR) has accepted TLC's late-breaking
abstract on TLC599 for oral presentation at ACR Convergence 2023.
This will take place November 10–15 at the San Diego Convention
Center in San Diego, California. TLC599 is a proprietary BioSeizer®
sustained release injectable in development for the treatment of
osteoarthritis pain.
Details of the event and presentation are as
follows: |
|
Session: |
Late-Breaking
Abstracts |
Time / Date: |
8:30am - 8:45am, Wednesday, November 15, 2023 |
Abstract ID: |
1651410 |
Final Number: |
L19 |
Abstract Title: |
A Phase 3 Study of Repeat Injection of TLC599 in Osteoarthritis
of the Knee: Benefits to 52 Weeks |
|
|
“We are pleased that the ACR has recognized the
importance of this Phase 3 data by selecting it for presentation,”
said Dr. David Hunter, Florance and Cope Chair of Rheumatology at
University of Sydney and principal investigator on the Phase 2 and
Phase 3 clinical trials for TLC599. “The data from this pivotal
Phase 3 trial demonstrates the sustained efficacy and safety of
TLC599 out to 52 weeks. We look forward to sharing these important
findings with the rheumatology community.”
The Phase 3 study, named EXCELLENCE, was a
randomized, double-blinded, placebo- and active-controlled study to
evaluate the efficacy and safety of TLC599 in single or repeat
doses, in patients with osteoarthritis of the knee. On the Western
Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain
scale, TLC599 was statistically superior at Week 12, the primary
endpoint, and numerically superior to placebo at all time points
through the first injection period. On the average daily pain (ADP)
scale, TLC599 was numerically and statistically superior to placebo
at all time points during the first injection period. Additionally,
the reduction in ADP for TLC599 was statistically superior to the
active comparator at Week 12. In the second injection period, the
mean reduction in ADP from the first injection baseline for TLC599
was numerically superior to placebo at all time points through Week
52 and statistically superior through Week 34. TLC599 was generally
well tolerated, with the number and type of adverse events similar
among all three treatment groups.
“The 52-week results demonstrate that TLC599 can
deliver durable pain relief and functional improvement, offering an
important new treatment option in the management of osteoarthritis
knee pain,” said Dr. George Spencer-Green, Chief Medical Officer at
TLC BioSciences. “These important data underscore our commitment to
developing therapies that provide sustained benefits and meet the
needs of patients living with chronic pain conditions.”
About TLC599
TLC599 is an extended and controlled release
liposomal corticosteroid injectable in development for the
treatment of osteoarthritis pain. Single and repeated doses of
current intraarticular anti-inflammatory treatments for
osteoarthritis have potentially toxic side effects and may lead to
the destruction of cartilage filler proteins. Preclinical toxicity
studies showed no marked cartilage damage after single and multiple
doses of TLC599 when compared to current treatments. In a Phase II
clinical trial, a single injection of TLC599 resulted in
statistically significant and clinically meaningful improvement in
WOMAC Pain and Function subscales, and VAS Pain scores over placebo
at 12, 16 and 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. No serious or unexpected treatment related adverse
events were reported, and most of the treatment related adverse
events were mild to moderate in severity.
About TLC BioSciences
TLC 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 platforms (LipAD®). TLC’s expertise
in liposome science allows for a combination of rapid onset and
extended benefit duration, enhancing active drug concentrations
while minimizing systemic exposures. TLC’s BioSeizer® technology
enables local sustained release of therapeutic agents at the site
of disease or injury, while its NanoX® active drug loading
technology has been proven in two approved drugs, altering systemic
exposure and potentially reducing dosing frequency. Versatile in
active pharmaceutical ingredients and scalable in manufacturing,
these technologies address unmet medical needs in orthopedics and
pain management.
Contact
Dawn Chi
Corporate Communications
Dawn@tlcbio.com
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