TLC Enrolls First Subject in Phase I Clinical Trial of Inhalable Anti-COVID-19 Program (TLC19)
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
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.
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
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