Company suspends enrolment to trials as coronavirus travel restrictions bite.
CHINA BATTLES 2019-NCOV AS COUNTRY SLOWLY RETURNS TO WORK AFTER NEW YEAR HOLIDAY
As the Wuhan coronavirus continues to spread both inside China and around the world, a number of pharma firms and vaccine developers are rushing to respond. Gilead Sciences Inc. has become the latest company to enter the fray, saying it is now working with both US and China regulators to get its experimental antiviral agent remdesivir to affected patients. There is currently no available effective antiviral drug for the new 2019-nCoV virus.
In a 31 January statement, the US antiviral specialist said it’s working with Chinese health authorities to establish a randomized, controlled trial to determine the safety and efficacy of its nucleotide analog prodrug, not yet approved anywhere for any use. This was originally intended for the Ebola and Marburg viruses, although it failed to show efficacy against Ebola.
“We are also expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples,” noted Gilead.
The company cited structural similarities between 2019-nCoV and previous viral pathogens MERS (Middle East Respiratory Syndrome) and SARS (Severe Acute Respiratory Syndrome), also caused by coronaviruses. “Remdesivir has demonstrated in vitro and in vivo activity in animal models" against both these, said Gilead, and the drug has been used compassionately in the first US case of the virus.
So far, the only antiviral officially recommended by China’s National Health Commission to treat the new Wuhan coronavirus is AbbVie Inc.’s combination for HIV, Kaletra (lopinavir and ritonavir), twice daily together with nebulized alpha-interferon.
Gilead added that it is also working with China's main drug regulator, the National Medical Products Administration (NMPA), along with the US FDA, Centers for Disease Control and other regulatory agencies to contribute antiviral expertise and resources to help fight the new outbreak.
A paper authored by Chinese researchers, based on 425 confirmed cases collected from Wuhan, shows that the transmission rate (Ro) of the new virus is 2.2, similar to that of SARS.
So far, the NMPA has fast-tracked the approval of seven testing kits for the new virus, and the agency said it is getting involved earlier and ready to grant approvals as applications come in.
Meanwhile, Chinese traditional medicine ShuangHuanglian has sold out overnight in China after the product was said to inhibit viral replication, although there are no supporting clinical studies showing its efficacy in this regard.
Other new vaccine development collaborations are also emerging in response to the crisis, including between Wuhan-based BravoVax and US vaccine developer GeoVax Labs Inc.BravoVax is situated in Wuhan’s Biolake, a biopharma hi-tech park which also hosts one of Pfizer Inc.'s main R&D centers in China.
BravoVax will provide development support, including testing and manufacturing, as well as direct interactions with Chinese authorities, while GeoVax will use its MVA-VLP platform and expertise to design and construct a vaccine candidate using genetic sequences from the ongoing coronavirus outbreak. (Also see "Asia Deal Watch: China’s BravoVax, US-based GeoVax Team Up On Coronavirus Vaccine" - Scrip, 31 Jan, 2020.)
The new alliance follows that between Johnson & Johnsonand Inovio Pharmaceuticals Inc., which have also said they intend to develop a vaccine for 2019-nCoV. (Also see "Coronavirus: Can Companies Achieve Vaccine Ambition?" - Scrip, 28 Jan, 2020.)
News from around the biopharma sector and its efforts to meet the challenges posed by the coronavirus pandemic.
By John Davis 01 Apr 2020
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