Hyundai Bio "COVID-19 Treatment, Aiming for Emergency Use Authorization in the First Half of Next Year"

CP-COV03 Phase 1 Clinical Trial Underway
Drug Delivery System Conjugated with Niclosamide
"Host-Targeted Antiviral Effective Against Variants"

On the 7th, at the Hyundai Bioscience press conference held at the Press Center in Jung-gu, Seoul, Choi Jin-ho, Chairman of the Scientific Advisory Committee of Hyundai Bioscience (founder of CNPharm), is making a presentation. (Photo by Hyundai Bioscience)

[Asia Economy Reporter Chunhee Lee] Hyundai Bioscience announced on the 7th that it aims to receive emergency use authorization for 'CP-COV03' (active ingredient 'Niclosamide'), an oral COVID-19 treatment under development, by the first half of next year.

On the morning of the 7th, Jin Geun-woo, head of research at Hyundai Bioscience, stated at a press conference held at the Press Center in Jung-gu, Seoul, "Currently, Phase 1 clinical trials of CP-COV03 are underway. After completing Phase 1 in January and confirming the drug in the blood, we will immediately proceed to Phase 2 clinical trials and plan to apply for emergency use authorization by the first half of next year." Last month, Hyundai Bioscience received approval from the Ministry of Food and Drug Safety for the Phase 1 clinical trial plan (IND) to administer CP-COV03 to 18 healthy adults to verify safety and other factors, and the trial is currently in progress.

CP-COV03 is a drug combining niclosamide, an antiviral agent used as an anthelmintic, with drug delivery system (DDS) technology from C&Pharm, Hyundai Bioscience's parent company. The company claims that this form of development can overcome difficulties in responding to COVID-19 caused by successive variants from Alpha to Omicron.

Director Jin emphasized, "The current antiviral drug development strategy targets the virus itself, so when mutations occur, the drug loses efficacy, and the problem of resistance cannot be overlooked. Niclosamide, which targets host cells regardless of viral mutations, can be an alternative." According to previous research conducted by the Korea Pasteur Institute, niclosamide showed 40 times higher antiviral efficacy than the COVID-19 treatment 'Remdesivir.'

However, niclosamide has the problem of having an absorption rate within the body of only about 10%. Jin Ho Choi, chairman of scientific advisory at Hyundai Bioscience and founder of C&Pharm, explained, "Niclosamide has been evaluated as unsuitable for use as a drug due to its low bioavailability. The reason for developing CP-COV03 is to increase bioavailability through drug delivery technology."

On the 7th, attendees are participating in a Q&A session at the Hyundai Bioscience press conference held at the Press Center in Jung-gu, Seoul. From left to right: CEO Sang-gi Oh, Chairman of the Scientific Advisory Committee Jin-ho Choi, Research Director Geun-woo Jin, and Chief Technology Officer (CTO) Kyung-il Kim. /Photo by Chunhee Lee.jpg

Hyundai Bioscience explained that animal experiments of CP-COV03 conducted at the Korea Research Institute of Bioscience and Biotechnology showed significant effects in treating the COVID-19 virus. When CP-COV03 and dexamethasone were co-administered to hamsters infected with the original COVID-19 virus discovered in Wuhan, China, the treatment effect was 2.1 times higher than with dexamethasone alone. According to the experimental results, the lung lesion improvement rate was 31.6% with CP-COV03 alone, 22.2% with dexamethasone alone, and 46.9% with the combination of CP-COV03 and dexamethasone.

Dexamethasone is a synthetic adrenal cortex hormone that suppresses inflammation and belongs to the steroid class of anti-inflammatory drugs. Currently, the combination therapy of remdesivir and dexamethasone is one of the main treatments for severe COVID-19 patients. Director Jin emphasized, "Dexamethasone can have side effects that reduce immune function, so it is necessary to find combination drugs that can provide appropriate antiviral efficacy. CP-COV03 is the optimal partner for co-administration with dexamethasone."

Hyundai Bioscience plans to secure viruses of other variants, including the Beta variant, in addition to the original COVID-19 virus, and further verify efficacy against those variants.

This content was produced with the assistance of AI translation services.