Chugai Initiates Actemra’s Phase 3 COVID-19 Trials in Japan

Recently, the USFDA approved phase 3 trials to evaluate the repurposed rheumatoid arthritis drug, Actemra in treating adult patients with severe COVID-19 pneumonia. Roche’s strategic partner, Chugai now follows suit in Japan.

Actemra is a recombinant, humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. It is the world’s first anti-IL-6 receptor antibody created in Japan and is originally prescribed for patients suffering from rheumatoid arthritis, Takayasu arteritis, and giant cell arteritis. Several studies and clinical reports have indicated that an over-activation of the immune response could be a major factor responsible for COVID-19 severity in patients. This phenomenon, known as the cytokine storm, is characterized by the increase of cytokines such as IL-2, IL-6, IL-10, etc. Besides, an elevated level of IL-6 has been associated with the need for mechanical ventilation. Due to this reason, Actemra is chosen as one of the potential candidates against the SARS-CoV-2 virus and is anticipated to benefit victims.

On March 23rd, Genentech, a member of the Roche group was approved by the FDA to conduct a double-blind, placebo-controlled Phase 3 clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the drug safety and efficacy of Actemra in patients with severe COVID-19 pneumonia. Now Japanese drug manufacturer, Chugai Pharmaceutical Co Ltd., a strategic partner of Roche has also announced plans to initiate phase 3 trials for Actemra in Japan. Chugai has filed a clinical trial notification with the Pharmaceuticals and Medical Devices Agency.

Scientists around the globe are confronting the COVID-19 challenge through multiple approaches. That includes the development and manufacture of COVID-19 detection kits, antibodies, vaccine candidates, convalescent plasma therapy and antivirals like remdesivir, kaletra (lopinavir/ritonavir) and favipiravir among others. Along the same lines, many repurposed drugs like Actemra, anti-malarial drug hydroxychloroquine, Asthma drug Alvesco, and anti-parasitic drug Ivermectin have shown early promise. Multiple clinical trials are currently ongoing around the world to test the efficacy of these candidates in treating COVID-19 patients. It remains to be seen, how many of them will turn out to be fruitful.

Related Article: Amgen, Adaptive Biotechnologies Collaborate to Strengthen COVID-19 Fight

References

1. https://www.chugai-pharm.co.jp/english/news/detail/20200324093000_711.html
2. https://www.chugai-pharm.co.jp/news/detail/20200408170000_969.html
3. https://www.medrxiv.org/content/10.1101/2020.04.01.20047381v1
4. https://www.medrxiv.org/content/10.1101/2020.03.30.20048058v1

Author

GeneOnline