Hyundai Bioscience announced positive phase 2 clinical study results of the global blockbuster candidate for the COVID-19 antiviral drug
- Hyundai Bioscience announcing the receipt of the phase 2 clinical study report of XaftyTM and its plans for the emergency use authorization
- Planning fast track process in oversea countries to enter the global market
SEOUL, South Korea, May 2, 2023 -- Hyundai Bioscience (KOSDAQ 048410) announced on the 28th that it had received the clinical study report for the COVID-19 phase 2 clinical trial of its antiviral drug 'Xafty' (code name: CP-COV03).
In the announcement, Hyundai Bioscience shared its plans to proceeding emergency use approval (hereafter, EUA) and approval process with the Korean Ministry of Food and Drug Safety (MFDS). Hyundai Bioscience plans to pursue other feasible fast-track processes for Xafty in oversea countries as well.
In this clinical trial, Xafty shortened the time required to improve 12 COVID-19 symptoms, including fever and cough, by 4 days compared to the placebo group. When taken within 3 days of symptom onset, the high-risk group improved the recovery time of 12 symptoms 6 days earlier than the placebo group. In addition, the viral load (virus level) was reduced by 56% by 16 hours after the first dosing, which is 14 times that of the placebo group (4% reduction).
Hyundai Bioscience research director, DR. G.W. Jin commented "COVID-19 is an RNA virus. It is characterized by a very fast infection rate and constant creation of variants within the same virus family. Hyundai Bioscience's Xafty has excellent efficacy against not only COVID-19 but also all corona-type viruses such as SARS and MERS. With drug repurposing, Xafty has safety and price competitiveness, making it a game changer for COVID-19."
These clinical results may be possible with Xafty's active ingredient, niclosamide's mechanism to remove viruses by activating cell autophagy, unlike existing antiviral drugs that inhibit viral replication. As a result of in vitro study on 48 types of drugs selected from 3,000 FDA- and IND-approved drugs by the Pasteur Korea Institute in 2021, niclosamide, an approved anthelmintic drug, was selected as the top candidate for COVID-19 antivirals. Hyundai Bioscience developed Xafty by repurposing niclosamide as a COVID-19 antiviral.
In this COVID-19 clinical trial of 300 patients, Xafty proved its safety with no serious adverse events. Considering its no known concomitant contraindications and its price competitiveness compared to existing COVID-19 treatments, Xafty is expected to be a standard COVID-19 treatment in the global market.
This clinical trial was carried out in consideration of the Korean EUA system in terms of scale. If Xafty is approved for emergent use, Korea would attain 'pharmaceutical sovereignty' as a country with a leading antiviral drug.
Hyundai Bioscience initially planned to enroll 180 patients in this clinical trial but expanded it to 300 to target the EUA introduced in Korea in March 2021.
SOURCE Hyundai Bioscience