Niclosamide, an anti-parasitic drug, has emerged as a strong candidate treatment for Covid-19.
Hyundai Bioscience on Thursday said its largest stakeholder CNPharm published a paper that proved the successful repurposing of niclosamide for Covid-19 treatment by using a drug delivery system (DDS), an original technology of CNPharm, in polymer science journal Polymers.
CNPharm is repositioning niclosamide as an oral Covid-19 treatment CP-COV03.
The paper, titled, “'Niclosamide–Clay Intercalate Coated with Nonionic Polymer for Enhanced Bioavailability toward COVID-19 Treatment,” showed that bioavailability of the repurposed niclosamide using CNPharm’s DDS increased by 60 percent, compared to the conventional niclosamide (brand name: Yomesan).
Niclosamide has drawn attention as a potential Covid-19 treatment since last year. However, drugmakers found it difficult to repurpose the anthelmintic drug because of its low absorption rate in the body and too short half-life of effective concentration in the blood.
“It is the first time that niclosamide's bioavailability improvement for drug repurposing has been published in an international journal,” an official at Hyundai Bioscience said.
CNPharm said the repurposed niclosamide could suppress Covid-19 variants and that the company would carry out a follow-up study.
CNPharm signed an agreement with DT&CRO, a clinical research organization (CRO), for a phase-2 trial of CP-COV03 in December.
Daewoong Pharmaceutical is also repurposing niclosamide as a Covid-19 treatment DWRX2003.
According to Daewoong, DWRX2003 inhibits viral proliferation by activating cell autophagy. The company said the investigational drug showed immediate antiviral and anti-inflammatory effects in a preclinical trial on hamsters.
Daewoong is waiting for the Ministry of Food and Drug Safety's approval for phase-2 clinical trials of DWRX2003 and conducting phase-1 studies in multiple countries.
After completing a phase-1 study in India, Daewoong runs a phase-1 trial in Korea, Australia, and the Philippines. The company said it would finish the trial in Australia within the second quarter of this year.
As the Philippines' study is being delayed due to Covid-19, the company will seek approval for phase-2 trials in Korea based on the results of the tasks in India and Australia.
The local phase-2 study will be on 200 Covid-19 patients with mild and moderate symptoms.
On March 30, Daewoong Infion, a joint venture in Indonesia, signed a memorandum of understanding with Indonesia’s National Institute of Health Research and Development (NIHRD) to conduct a phase-2a trial of DWRX2003 in Indonesia.
“Based on data from phase-1 studies overseas, we plan to apply for phase-2 study in the U.S. within the first half,” an official at Daewoong said.
In February, DWRX2003 won the Korea Health Industry Development Institute's support for the building of production facilities for Covid-19 treatment.
Daewoong will get 1.95 billion won ($1.75) annual support from the Korea Innovative Medicines Consortium (KIMCo) to build manufacturing facilities and prepare mass-production of DWRX2003 within this year, the company said.