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August 2, 2021, 11.54 am

Regdanvimab Reduced The Risk of COVID-19-related Hospitalization or Death for Patients with Comorbidities

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  • Regdanvimab (RegkironaTM) is recommended to treat confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and are at high risk of progressing to severe COVID-19. The recommended dosage of Regdanvimab is a single intravenous infusion of 40 mg/kg. Treatment should be initiated as soon as possible after diagnosis, and not later than 7 days after the onset of symptoms.
  • According to clinical studies, regdanvimab (RegkironaTM) significantly reduced the risk of COVID-19 related hospitalization or death by 72% for patients at high risk of progressing to severe COVID-19 by day 28. RegkironaTM also reduced the risk of COVID-19 related hospitalization or death by 70% for all patients.
  • Patients who were treated with regdanvimab (RegkironaTM) and standard Covid-19 treatment reported a significantly shortened time to clinical recovery compared to those who only received standard COVID-19 treatment by at least 4.7 days quicker for patients at high risk of progressing to severe COVID-19 and by 4.9 days quicker for all patients.
  • Pre-clinical data for regdanvimab (RegkironaTM) demonstrates strong neutralizing activity against the SARS-CoV-2 virus Delta variant.

JAKARTA, JULY 2021 — According to data from covid-19.go.id, around 49,5% of Covid-19-related deaths in Indonesia have occurred among the elderly or people 60 and older. This age group is at high risk as it is likely to have comorbidities, such as diabetes mellitus, hypertension, heart disease, kidney disease, chronic lung disease, chronic liver disease, cancer, and others. A monoclonal antibody treatment regdavimab was introduced to reduce the risk of COVID-19 related hospitalization or death by 72% for patients with comorbidities.

Dexa Medica as a leading Indonesian pharmaceutical company has officially launched RegkironaTM with Regdanvimab, a monoclonal antibody treatment developed by a leading South Korean pharmaceutical company, Celltrion Healthcare for COVID-19 patients in Indonesia. Regdanvimab was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralizing the SARS-CoV-2 virus.

The announcement regarding the appointment of Dexa Group as the exclusive license holder of RegkironaTM in Indonesia was made by the Director of Business and Scientific Development of PT Dexa Medica, Dr. Raymond Tjandrawinata in Jakarta on Saturday, July 31, 2021. Regdanvimab is the first monoclonal antibody treatment in Indonesia that is indicated for Covid-19 treatment.

“Indonesia currently needs immediate action to deal with COVID-19 pandemic as new cases and hospital bed occupancy rate have been significantly increasing for the past weeks. Indonesia has recorded more than 3.24 million active cases. As the government’s vaccination program is still underway, COVID-19 confirmed cases keep increasing, Dexa Group takes the initiative to support the government’s efforts to obtain the market license of RegkironTM a from Celltrion Healthcare, South Korea. RegkironaTM as one of the anti-COVID-19 treatments for patients in Indonesia has gone through a phase III clinical trial with positive top-line results,” said Dr. Raymond Tjandrawinata.

Dexa Group has obtained the emergency used authorization (EUA) from the National Agency of Drug and Food Control of The Republic of Indonesia to import and launch RegkironaTM in the country to meet the demands of doctors and hospitals for COVID-19 patients treatment.

“We need inputs regarding the projection of RegkironaTM demands from each COVID-19 Referral Hospital so that we can place orders to our partners in the right amount,” explained Dr. Raymond Tjandrawinata.

Dr. Raymond Tjandrawinata added, results from the global Phase I and II clinical trials of regdanvimab or RegkironaTM demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild to moderate symptoms of COVID-19.

“In vitro and in vivo pre-clinical studies showed that regdanvimab strongly binds to SARS-CoV-2 Receptor Binding Domain and significantly neutralizes the wild type and mutant variants of concern including the Alpha variant or B.1.17. In in vivo models, regdanvimab effectively reduced the viral load of SARS-CoV-2 and inflammation in lung,” he explained.

In mid-June 2021, Celltrion Healthcare announced top-line efficacy and safety data based on the global Phase III clinical trial, demonstrating that anti-COVID-19 monoclonal antibody treatment, regdanvimab (RegkironaTM), met all primary and key secondary endpoints in patients with mild to moderate symptoms of COVID-19 (sample size 1,315). The research showed RegkironaTM significantly reduced the risk of COVID-19 related hospitalization or death by 72% for patients at high risk of progressing to severe COVID-19 by day 28. RegkironaTM also reduced the risk of COVID-19 related hospitalization or death by 70% for all patients.

“The mechanism of action of regdanvimab is by binding to the Receptor Binding Domain or RBD of the SARS-CoV-2 spike protein, then inhibiting the interaction with the cellular receptor or ACE2 and thus blocking the entry of cells and SARS-CoV-2 infection,” added Dr. Raymond.

Patients who were treated with regdanvimab (RegkironaTM) reported a significantly shortened time to clinical recovery by at least 4.7 days quicker for patients at high risk of progressing to severe COVID-19 and by 4.9 days quicker compared to placebo for all patients. The treatment reduced severe symptoms of COVID-19 in 70 percent of patients, including high-risk groups with comorbidities.

Therapeutic effect of regdanvimab against virus B.1.351 variant (first identified in South Africa, now classified by the WHO as Beta) was updated through the publication from Biochemical and Biophysical Research Communications. According to the article, in vivo ferret challenge studies demonstrated that a therapeutic dosage of RegkironaTM was able to decrease viral load of Beta variant in the upper and lower respiratory tracts.

The pre-clinical in vivo study assessed the neutralization effect of regdanvimab against SARS-CoV-2 virus Delta variant. In addition to showing in vivo effectiveness against Delta and Beta variants, regdanvimab showed positive results against Gamma variant (P.1, first identified in Brazil), which was comparable to that against wild type SARS-CoV-2. Regdanvimab also demonstrated strong neutralizing capability against the Lambda variant (C.37, first identified in Peru) in a cell-based pseudo- virus assay study performed by the National Institutes of Health (NIH), United States of America.

A number of Indonesian medical professional associations, namely the Indonesian Lung Doctors Association (PDPI), the Indonesian Cardiovascular Specialist Doctors Association (PERKI), the Indonesian Association of Internal Medicine Specialists (PAPDI), the Indonesian Association of Anesthesiologists and Intensive Therapists (PERDATIN), the Indonesian Pediatrician Association (IDAI) has issued a recommendation for monoclonal antibody therapy, including regdanvimab in the Proposed Revision of COVID-19 Guidelines, dated July 14, 2021. The guideline stated that regdanvimab can be used to treat confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and are at high risk of progressing to severe COVID-19. The recommended dosage of regdanvimab is a single intravenous infusion of 40 mg/kg. Treatment should be initiated as soon as possible after diagnosis, and not later than 7 days after the onset of symptoms.

European Medicines Agency (EMA) has also given positive review for the use of regdanvimab as a treatment for COVID-19 patients who are at high risk of developing severe symptoms.

For more information, please contact:
Sonny Himawan
Head of Corporate Communications Dexa Group
orporate.communications@dexagroup.com

Reference:

  • RegkironaTM. Fact sheet for health care providers Emergency Use Authorization (EUA) of regdanvimab for the treatment of Covid-19 patients. PT Dexa Medica. 2021.
  • PDPI, PERKI, PABDI, PERDATIN, IDAI. Proposed Revision of Covid-19 Guidelines; July 2021.
  • Celltrion Healthcare. Celltrion announces positive top-line results from global phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment. Available from: https://www.celltrionhealthcare.com/enus/board/newsdetail?modify_key=498&pagenumber=1&key-
  • Business Wire India. Celltrion’s monoclonal antibody treatment for Covid19, regdanvimab (CT-P59), demonstrates strong neutralising activity against delta variant. Available from: https://www.businesswireindia.com/celltrions-monoclonal-antibody-treatment-for-covid-19-regdanvimab-ct-p59-demonstrates-strong-neutralising-activity-against-delta-variant-74030.html
  • Byrne, Jane. Celltrion: COVID-19 antibody treatment effective against delta variant. Available from: https://www.biopharma-reporter.com/Article/2021/07/19/Celltrion-COVID-19-antibody-treatment-effective-against-Delta-variant
  • EP News Bureau. Celltrion’s monoclonal antibody treatment for Covid-19 works against delta variant: study. Available from: https://www.expresspharma.in/celltrions-monoclonal-antibody-treatment-for-covid-19-works-against-delta-variant-study/
  • CNN Indonesia. BPOM to approve emergency authorization of covid-19 treatment Regdanvimab. Available from: https://www.cnnindonesia.com/nasional/20210713131558-20-667004/bpom-segera-beri-izin-darurat-obat-covid-19-regdanvimab
  • Covid-19 Task Force. Map of The Spread of Covid-19. Available from: https://covid19.go.id/peta-sebaran-covid19