In more than a dozen medical institutions in Wuhan, a new drug called “Redsywe” is undergoing clinical trials. How are drug clinical trials progressing and can production keep up? Dr. Merdad Parsey, chief medical officer of Gilead Sciences in the United States, said in an exclusive interview with Xinhua that the “Redsiwe” effect is still being tested clinically, and that researchers have some data in about a month, and that the drug is currently being produced 24 hours a day.
Updates on Redciewe and its clinical trials for the treatment of new coronavirus pneumonia
Source: Gilead WeChat Public No.
Redciewe has demonstrated the activity of Merthyr (MERS) and atypical pneumonia (SARS) virus pathogens in in vitro and in vitro animal models, which are also coronaviruses and are structurally similar to new coronaviruses. The new coronavirus is a new virus that currently does not have approved drugs and no clinical trial data on potential treatments. Limited preclinical data on MERS and SARS suggest that Redcivir may have potential lynovirus activity. It is not clear whether Redciewe will show any clinical activity with the new coronavirus.
At Gilead, we are aware of the urgency of responding to outbreaks. We have been fully cooperating with chinese government agencies in their research on Redciewe as a potential therapeutic drug. With strong support from Chinese government agencies, we were able to quickly establish two randomized, controlled trials for the evaluation of Redciwe, one for patients with severe illness and one for patients with moderate illness.
Both trials are being carried out in several hospitals in Hubei Province, with patients in the process of being enrolled. Clinical trials are coordinated by the Sino-Japanese Friendship Hospital. Patients will receive a 10-day Reedsiwe intravenous injection. The main endpoints of the two studies included an improvement in clinical symptoms 28 days after treatment. We expect to get the results of the trial in April.
It is important to note that Redcivir is an experimental drug that has so far been used by only a very small number of patients infected with the new coronavirus, so we do not have sufficient understanding of the efficacy of Redcievir and are not currently sufficient to ensure that the drug is widely used. By comparing it with the placebo group, the trial will be able to determine the key issues of Redcywe’s safety and effectiveness.
Gilead’s hundreds of employees are working around the clock to do everything we can to help fight the outbreak. Now, our primary consideration is to support clinical trials in China to determine the safety and efficacy of Redcievir in the treatment of new coronavirus pneumonia, and, despite certain risks, we are doing our utmost to accelerate production and increase the availability of Ridsywe.
For now, Gilead does not consider the potential commercial value of the drug under study. We are now focusing on the potential clinical value that Redcivir can bring to patients and do everything we can to help respond to outbreaks of new coronavirus pneumonia. Gilead is also in discussions with regulators to determine the most appropriate path for Redsey to get approval if clinical trial results are positive.
Gilead is committed to supporting the extraordinary efforts of front-line doctors and medical first responders to help patients with new coronary pneumonia. We are working with government agencies, academic institutions, nonprofits, researchers, and clinicians to share information and deploy resources efficiently around the world to help patients and communities fight pneumonia caused by the new coronavirus.