コロナ経口治療薬、治験でウイルス量低減効果　米メルク

【サンフランシスコＡＦＰ＝時事】米製薬大手メルクと米バイオ医薬品企業リッジバック・バイオセラピューティクスは6日、共同開発する新型コロナウイルス感染症（COVID-19）の経口治療薬の臨床試験（治験）で、患者の体内のウイルス量を減らす効果が示されたと発表した。（写真は資料写真）
　メルクは１月、新型ウイルスのワクチン候補の開発を打ち切り、治療薬２種の研究を進めていた。
　そのうちの一つがリッジバックと共同開発する錠剤の「モルヌピラビル」で、メルクは、同薬を５日間服用した後で患者のウイルス量が大幅に減少したと発表した。
　新薬の承認までには３段階の臨床試験があり、今回の第２ａ相試験は、入院していないＣＯＶＩＤ-１９有症状者２０２人を対象に実施された。
　リッジバックによれば、安全性に懸念はなく、報告された４件の重篤な有害事象のいずれも治療薬に関連したものではないと判断された。
　研究を主導した米ノースカロライナ大学のウイリアム・フィッシャー教授（医学）は、今回の臨床試験の結果に期待を示している。
　メルクは１月、開発中のもう一つの経口治療薬「ＭＫ-７１１」について、入院中の中等症・重症患者の死亡または呼吸不全に陥るリスクが５０％以上減少したことが臨床試験の暫定結果で分かったと発表していた。【翻訳編集ＡＦＰＢＢＮｅｗｓ】

〔ＡＦＰ＝時事〕（2021/03/09-14:08）

German pharmaceutical giant Merck and a US partner reported promising results Saturday in trials of a drug administered orally to fight Covid-19, saying it helps reduce patients' viral load.
At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data, said Wendy Painter, chief medical officer of the US firm, Ridgeback Biotherapeutics.
In January, Merck halted work on two Covid vaccine candidates but has pressed on with research into two products to treat the disease, including a pill-based one called molnupiravir, which it has developed with Ridgeback Biotherapeutics.
This drug caused a significant drop in patients' viral load after five days of treatment with it, Merck said at a meeting with infectious disease experts.
This Phase 2a test -- drug trials have three stages before a product can be approved -- was carried out among 202 non-hospitalized people with symptoms of Covid-19.
There was no alert in terms of safety, and of four serious adverse events that were reported, none were considered to be related to taking this drug, Ridgeback said.
Anti-viral oral drugs such as oseltamivir (Tamiflu) and zanamivir (Relenza) are sometimes prescribed for seasonal flu but researchers have yet to come up with something similar to fight the coronavirus.
The findings of this study -- a quicker decrease in viral load among individuals with early-stage Covid-19 who are treated with molnupiravir -- are promising, said William Fischer, lead investigator of the study and a professor of medicine at the University of North Carolina.
If supported by additional studies, (they) could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally, Fischer added.
Merck is also working on another oral Covid treatment called MK-711.
Preliminary results from clinical trials with it show a more than 50 percent reduction in risk of death or respiratory trouble in patients hospitalized with moderate to severe Covid-19, the company said in January.