TLC Enrolls First Subject in Phase I Clinical Trial of Inhalable Anti-COVID-19 Program (TLC19)
14 Octobre 2020 - 10:40AM
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty
pharmaceutical company developing novel nanomedicines to target
areas of unmet medical need, today announced that the first subject
has been enrolled in the Phase I clinical trial of TLC19 for
treatment or prophylaxis of Coronavirus disease 2019 (COVID-19).
TLC19 is a proprietary liposomal formulation of
a small amount of hydroxychloroquine (HCQ) for inhalation. A paper
by Kavanagh, Oisín et al suggests that inhaled HCQ may improve
efficacy and reduce harm in the treatment of COVID-19, and
liposomal formulations have long been shown to possess the
advantages of efficient drug delivery directly to the disease site
and achieving sustained release to prolong drug residence time. In
preclinical studies, TLC19 demonstrated 30-fold exposure in the
lungs while achieving lower blood and heart exposure than oral HCQ
and unformulated HCQ. Thus, TLC19 can potentially inhibit the
first-line entry and replication of SARS-CoV-2 in the upper
respiratory tract and lungs, as well as preventing its subsequent
neuro-invasion to the brain.
The Phase I randomized, vehicle-controlled,
blinded study will evaluate the safety, tolerability, and
pharmacokinetics of single ascending doses of inhaled TLC19 in 30
healthy volunteer subjects. Three dose levels – 4mg, 8mg, and 12mg
– will be assessed in sequential cohorts. Within each cohort,
approximately 10 evaluable subjects will be enrolled and randomized
in a ratio of 8:2, with 8 subjects receiving TLC19 and 2 subjects
receiving a TLC19 vehicle, which is the same liposomal formulation
but without the active pharmaceutical ingredient of
hydroxychloroquine. Study medication is administered through
inhalation via a commercially available portable vibrating mesh
nebulizer, and all subjects will be followed up for 4 weeks.
“The prompt commencement of subject enrollment
is a testament of our dedication to accelerate the TLC19 program as
quickly as possible,” said George Yeh, President of TLC. “Within
the last 24 hours, two late-stage COVID-19 clinical trials in the
United States – a vaccine and a monoclonal antibody – have been
suspended, making our mission to provide a means of defense against
the deadly virus more important than ever. Along with our clinical
progress in Australia and Taiwan, we are also making good speed on
the GMP manufacturing side, preparing for large-scale commercial
production of TLC19 in Taiwan and potentially in the United
States.”
The International Society for Aerosols in
Medicine (ISAM) issued a statement imploring regulatory authorities
to use prior, documented safety data already in their possession to
expedite the development of “repurposed” out-of-patent drugs for
the inhaled route of administration during COVID-19, as the doses
required to achieve high lung concentrations are typically much
lower than their daily doses by other routes. As TLC19 is a
repurposed, inhaled version of the off-patent malaria drug HCQ,
physiologically based pharmacokinetic modeling from the Phase I
pharmacokinetic results could be leveraged to rapidly enable dosing
in subsequent trials of patients with COVID-19, which TLC plans to
conduct in areas impacted the most by the pandemic.
About TLC19
TLC19 is a liposomal suspension of
hydroxychloroquine (HCQ) for inhalation. HCQ has shown potential in
prophylaxis and/or treatment for COVID-19 in in vitro and
preliminary clinical trial studies, but orally administered HCQ
cannot reach therapeutic levels due to its dose-limiting
toxicities. TLC19 utilizes ~1% of the highest oral HCQ dose tested
and delivers the drug directly to the airways and lungs,
potentially avoiding systemic toxicities associated with oral HCQ
while providing a sustained effective concentration at the primary
site of infection. TLC19 is designed to be cost-effective, easily
accessible and can be self-administered with a portable
nebulizer.
About TLC
TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage
specialty pharmaceutical company dedicated to the research and
development of a diverse, wholly owned portfolio 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.
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. 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. 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. 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.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/52a82e76-9fa3-4f96-8994-eeda51499594
Contact
Dawn Chi
Corporate Communications
dawn@tlcbio.com
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