South Korea's Hyundai Bioscience (KOSDAQ: 048410) reported that its niclosamide (NIC) oral treatment for COVID-19 increased the sustained bioavailablity of the API. In an animal test, CP-COV03 brought the viral inhibition (IC50) level of niclosamide up to 300 times the IC50 level and maintained the level at or above IC50 for 24 hours. Although niclosamide is recognized as a potential treatment for antiviral drugs, it has poor oral availability in its natural state. A Hyundai subsidiary, CNPharm, will test CP-COV03 in humans.

To create CP-COV03, CNPharm first immobilized NIC molecules in cationic clay (MMT) to increase the solubility of NIC. Then, a polymer surfactant, Tween 60, was applied to coat the molecules and spread the duration of action to more than 24 hours. The results of the pre-clinical test were published in a special issue of Pharmaceuticals.

Hyundai said CP-COV03 has been recognized globally as a potential "game-changing" candidate for an oral treatment that could compete with other oral antiviral drugs for COVID-19 being developed by Merck, Pfizer and Roche, or Tamiflu which was an oral drug developed for the H1N1 pandemic.

In the paper titled "Niclosamide–Clay Intercalate Coated with Nonionic Polymer for Enhanced Bioavailability toward COVID-19 Treatment,"  the bioavailability of the repurposed Niclosamide formulation using CNPharm's cationic drug delivery system (DDS) was increased by 60% compared to Yomesan, the current anthelmintic formulation of Niclosamide.

Hyundai added that the 300-fold gap between Cmax and IC50 concentrations in the animal test indicates that the therapeutic window of this drug is wide enough to increase its possibility of success as an antiviral drug and attract attention from Big Pharma that has been in need of such game changer drugs for COVID-19.

The company further said that niclosamide not only inhibits viral replication as other game changer antiviral drug candidates do, but it also degrades and eliminates virus within the cell as well as preventing lung damage caused by coronavirus.

Hyundai said it is ready to start clinical trials in Korea and internationally for CP-COV03 based on the results of preclinical studies of CNPharm. It will also seek to form collaborations or licensing opportunities with global pharmaceutical companies.

Hyundai has developed a bio-fusion technology to deliver active ingredients safely and efficiently to targeted areas of the body. The company believes its Organic-Inorganic Hybrid Technology allows the selective and effective delivery of active substances to the target area in combination with bio-friendly delivery vehicles.

Disclosure: none.