Seoul, South Korea – HYUNDAI BIOSCIENCE Co., Ltd. (KOSDAQ: 048410) has disclosed the key points of the statistical analysis report for the phase 2 clinical trial results of CP-COV03, a COVID-19 treatment, received from its Contract Research Organization (CRO) on April 13, 2023.
■ CP-COV03, high efficacy shown even in high-risk group for COVID-19
Among 300 patients in the CP-COV03 phase 2 study, the primary end point, symptom improvement, was evaluated on the sub group of mild or moderate level COVID-19 patients who were at high-risk of developing severe symptoms. The results showed that the time taken to improve symptoms was shortened by six days compared to the placebo group (P=0.0080). Moreover, the high-risk patients who were concurrently taking medications were treated with CP-COV03 alongside existing medications (such as medication for high blood pressure, diabetes, etc.).
CP-COV03 was world’s first case to statistically show improvement of symptoms in the primary efficacy evaluation, including both standard and high-risk groups in the announcement of phase 2 clinical trial top-line results on March 10th, confirming that CP-COV03 successfully shortened the period required for symptom improvement by 4 days compared to the placebo group (P=0.0083) as a result of the primary efficacy evaluation of the phase 2 clinical trials.
As the excellent improvement of symptoms was confirmed, not only in the standard-risk group but also in the high-risk group, CP-COV03 is expected to become the world's first standard treatment for COVID-19 that both standard and high risk COVID-19 patients can take.
■ Improvement of symptoms in high-risk groups, even when combined with existing medications
Paxlovid was approved for emergency use in high-risk patients for reducing risk of hospitalization and death, but with 37 contraindications, many of which are taken by high-risk patients. It has not achieved the prescribing uptake expected by health authorities. Lagevrio, which was introduced to address these issues, is free of drug interactions, but prescribing it has been limited due to recent concerns about its effectiveness in vaccinated patients.
Early dosing is critical to minimize severe conversion in high-risk groups. However, Paxlovid has many contraindications and Lagevrio is underprescribed due to its efficacy concerns in vaccinated patients. A safer drug like CP-COV03, with less side effects and no known contraindications, is needed to boost prescriptions.
CP-COV03 is a safe drug that can be prescribed to any risk-level patients who has been diagnosed with COVID-19, not just high-risk patients who are naturally expected to have higher prescription rates. Higher prescribing rates are expected to contribute to minimizing severe conversion in high-risk groups.
■ CP-COV03 reduces viral load 14-fold in 16 hours after first dosing
16 hours after the first dose, CP-COV03 achieved 56.7% viral load reduction rate, which is approximately 14-fold (p=0.0185) better than the placebo group with 4.1% reduction rate. Such viral load reduction rate of CP-COV03 is a remarkable achievement that has not been seen in existing COVID-19 therapeutics that were developed using conventional antiviral development methods.
CP-COV03 is a host-targeted antiviral that activates the cell's autophagy mechanism to induce the cell to eliminate the virus. This is an unprecedentedly safe way to treat virus infection, and is expected to help patients achieve faster symptom relief and recovery, with a reduced rate of severe conversion and a reduced likelihood of severe complications.
CP-COV03 has previously been proven to have antiviral efficacy against various mutations of the COVID-19 virus, such as alpha, beta, gamma, and omicron, and is expected to play an important role in the response strategy to COVID-19. In other words, it will be of great help in switching to early diagnosis and early treatment in the event of a recurrent outbreak due to a new mutation in the future. In addition, CP-COV03 is expected to have an antiviral effect against other types of viruses as well as COVID-19. It has been reported by researches that 31 major viral diseases including SARS-CoV-2, can be treated with Niclosamide, the active ingredient of CP-COV03. Now this clinical study result may be a starting point to demonstrate the potential for a broad-spectrum antiviral drug, confirming safe efficacy against COVID-19, one of those 31 major viruses.
As a result, CP-COV03 will function as a broad-spectrum antiviral drug, prepared for phase 2 clinical trial against any other virus than COVID-19, which will provide new hope in the fight against viruses in the future.
CP-COV03 demonstrates for the first time that a novel mechanism to eliminate viruses by autophagy is clinically feasible for COVID-19. This safe approach to treating the virus produced a remarkable 14-fold reduction in viral load compared to placebo within 16 hours after first dosing. This demonstrated that universal antivirals are possible with the promise of CP-COV03 as the world's first universal antiviral drug candidate.
■ COVID-19 therapeutics market trends and outlook
The global market for COVID-19 therapeutics was valued at approximately $28.5 billion in 2020 and is expected to grow at a CAGR of 10.2% to reach $51 billion by 2026, according to KISTI. Paxlovid generated $18.9 billion in sales in 2022, while Lagevrio, an alternative to Paxlovid, generated $5.7 billion in sales, about 30% of Paxlovid's sales.
Paxlovid has 37 contraindications that prohibit its use in high-risk patients with underlying medical conditions, making it difficult for doctors to prescribe it. Nevertheless, Paxlovid is expected to generate $8 billion in sales by 2023, while Lagevrio, which the European Committee for Medicinal Products for Human Use (CHMP) recommended against approval due to efficacy concerns in vaccine recipients, is expected to generate $1 billion in sales.
Meanwhile, Xocova, which targets the standard-risk group, is expected to generate $2 billion in sales in 2023, according to its manufacturer, Shionogi Pharmaceuticals. The Japanese government has estimated that annual sales could exceed 300 billion yen ($ 2.2 billion).
The market for COVID-19 therapeutics is expected to continue to grow. Oral COVID-19 therapeutics are expected to replace the majority of the COVID-19 vaccine market as the urgency to vaccinate decreases due to COVID-19 mutations. CP-COV03 is expected to become a blockbuster drug as it is the first oral antiviral drug in Korea with safety and excellent efficacy with no concomitant contraindications, unlike existing antiviral drugs.