TLC Submits IND Application In Taiwan For TLC19 Inhalable Liposomal Hydroxychloroquine For COVID-19

(RTTNews) - Taiwanese specialty pharmaceutical company Taiwan Liposome Co. Ltd. (TLC) announced Friday the submission of an Investigational New Drug (IND) Application to the Taiwan Food and Drug Administration (TFDA) for TLC19 Hydroxychloroquine Liposome Inhalation Suspension for the treatment of coronavirus (COVID-19) disease.

TLC19 utilizes TLC's existing proprietary liposome technology to encapsulate about 1/100 of the oral HCQ dose into an inhalable formulation for direct deposit into the airways and lungs.

A recent manuscript showed that, at equivalent doses, inhalable liposomal HCQ achieved increased exposure (about 30-fold) and half-life (about 2.5-fold) in the lungs than oral HCQ. TLC19 can achieve antiviral effect with a miniscule dose compared to orally administered HCQ while lowering blood and heart exposure, giving TLC19 the potential to treat COVID-19.

TLC is working in collaboration with MicroBase Technology Corp., who specializes in the development of inhalation devices for the treatment of respiratory diseases, to expedite the development of TLC19's inhalation suspension formulation.

TLC19 is administered with a light and commercially available portable nebulizer whose ease of use is especially suitable for outpatient treatment of mild COVID-19 patients.

The company said a Phase I clinical trial is expected to begin and will enroll healthy volunteers in Taiwan to collect pharmacokinetic and safety data on a new liposome formulation with the new inhalation route.

The Phase II/III clinical trials are scheduled to take place in the United States and other countries impacted the hardest by the pandemic.