Hydroxychloroqine Could Be Back in Play With Recent Taiwan FDA Filing

Health and Healthcare

Published: August 14, 2020 11:27 am

Taiwan Liposome Co. Ltd (NASDAQ: TLC) shares shot higher on Friday after the company announced it was making a regulatory filing for a COVID-19 treatment that has been at the center of some controversy.

The firm is filing an Investigational New Drug (IND) Application to the Taiwan Food and Drug Administration (TFDA) for TLC19 hydroxychloroquine liposome inhalation suspension for the treatment of COVID-19.

Hydroxychloroquine (HCQ) has been at the heart of much debate over the safety and efficacy when applied to patients with COVID-19. Recent studies suggest that “HCQ can prevent the acidification of intracellular organelles, inhibit lysosomal release of viral genome and interfere with the glycosylation of the angiotensin-converting enzyme-2 (ACE2) receptor on the host cell, reducing the binding efficiency between the receptor and spike protein on the surface of the coronavirus and thereby reducing the chances of COVID-19 infection and replication.” Therefore, on the molecular and cellular levels, HCQ has been shown to achieve antiviral activity against SARS-CoV-2.

On the other hand, the U.S. FDA emphasized the importance of translating in vitro antiviral activity to appropriate clinical dosing regimens and concluded that “antiviral effect against SARS-Cov-2 was not likely achievable with a safe oral dosing regimen” of HCQ due to dose confinement by potential cardiotoxicity. The U.S. FDA revoked emergency use authorization for HCQ, and recent clinical trials studying orally administered HCQ were halted.

TLC19, administered through a vibration mesh nebulizer, can achieve antiviral effect with a miniscule dose compared to orally administered HCQ, while lowering blood and heart exposure. Ultimately, this gives TLC19 the potential to treat COVID-19.

Taiwan Liposome stock traded up over 41% at $7.20, in a 52-week range of $2.48 to $12.65. The consensus price target is $12.75.

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