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REMDESIVIR CORONAVIRUS EFFICACY NOT GUARANTEED

While clinical studies are still ongoing for Gilead Sciences Inc.'s remdesivir in China, there is already high hope in the country that the antiviral will be effective against the SARS-CoV-2 coronavirus.

A trial initiated in early February in Wuhan, the original epicenter of the outbreak, is being led by Bin Cao, vice-president of the Sino Japan Friendship Hospital as primary investigator. In a recent media interview, Cao noted strong comparative antiviral activity for the Gilead molecule, first developed for the Ebola virus. The World Health Organization has also said that remdesivir could be an effective treatment and in China the drug is now being billed as “the people’s hope.”

But while the nucleotide analog has shown good efficacy in vitro, this will not automatically translate into effectiveness against the virus causing COVID-19, the respiratory disease caused by the virus, Jim Wu, CEO of Chinese firm Ark Biosciences Inc., toldScrip in an interview. Wu was formerly head of research and early development for Roche in China and ArkBio is developing a novel treatment for respiratory syncytial virus.  

Wu urged patience over remdesivir, cautioning that until results are out, its potential utility remains largely uncertain. The Phase III data are not expected until 27 April. A trial is also underway in the US. (Also see "COVID-19 Study Of Gilead’s Remdesivir Using Ebola-Style Adaptive Platform Trial" - Pink Sheet, 17 Mar, 2020.)

Meanwhile, China is also testing a flurry of other antivirals including flu drug favipiravir and AbbVie Inc.’s anti-HIV combination Kaletra (lopinavir and ritonavir), while Bayer AG’s antimalarial chloroquine, Roche/Chugai Pharmaceutical Co. Ltd.’s anti-inflammatory antibody Actemra (tocilizumab) are also part of investigations.

Favipiravir has been filed for investigation by China's Zhejiang Hisun Pharmaceutical Co. Ltd. as a generic drug, since the local patent for the original Fujifilm Toyama Chemical Co. Ltd. product has expired. Development is proceeding rapidly and three studies are already underway, two in Zhejiang province (where Hisun is based) and one in Shenzhen.

Vaccines Remain Key

US firm  Moderna Inc. recently announced it had dosed the first person with its mRNA-based vaccine for coronavirus, becoming the first to take a potential vaccine into a clinical trial. Other vaccines are moving forward, with Pfizer Inc.,Shanghai Fosun Pharmaceutical Group Co. Ltd. and BioNTech SE most recently announcing a collaboration. (Also see "Pfizer, Fosun Partner BioNTech On mRNA COVID-19 Vaccine" - Scrip, 17 Mar, 2020.)

Relatively quicker to develop that standard vaccines, mRNA vaccines have an early lead but ArkBio's Wu said the early lead won’t necessarily translate into clinical success, and that vaccines needed to be tested on more people.

Given the active role played by vaccines to protect large populations, they will have an active role in fighting the outbreak, Wu said.

China Emphasizes TCMs

Meanwhile, China is also promoted an integrated approach in new guidelines that promotes the co-use of traditional Chinese medicines (TCMs). This is designed to treat COVID-19 patients with different regimens categorized into three levels based on symptoms: mild, moderate and severe. While mild patients can be treated with TCMs, those with moderate or severe disease are given a combination of antivirals and TCM injections.

From the beginning, China's National Health Commission has included TCMs along with antivirals in its guidelines, and TCMs account for the majority of clinical trials for COVID-19 in China, which now total 470.

The government has also moved to tighten rules over the trials and more than 35 have been cancelled including with some traditional therapies. 

(Scrip's rolling coverage of the global coronavirus outbreak and the biopharma industry's response is aggregated here.)

A new Coronavirus Analytic Solution including comprehensive integrated data on clinical trials, pipeline, market events and insights from across Pharma Intelligence’s suite of products, updated daily, is now available. Contact Duncan Emerton, PhD; Director, Custom Intelligence & Analytics for details (separate purchase required).

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