Merck pill seen as ‘huge advance,’ raises hope of preventing Covid-19 deaths

Reuters

An experimental antiviral pill developed by Merck & Co could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19, according to data that experts hailed as a potential breakthrough in how the virus is treated.

If it gets authorization, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

Merck and partner Ridgeback Biotherapeutics said they plan to seek U.S. emergency use authorization for the pill as soon as possible and to make regulatory applications worldwide.

“An oral antiviral that can impact hospitalization risk to such a degree would be game-changing,” said Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security.

Current treatment options include Gilead Sciences Inc’s infused antiviral remdesivir and generic steroid dexamethasone, both of which are generally only given once a patient has already been hospitalized.

“This is going to change the dialogue around how to manage COVID-19,” Merck Chief Executive Robert Davis told Reuters.

Existing treatments are “cumbersome and logistically challenging to administer. A simple oral pill would be the opposite of that,” Adalja added.

The results from the Phase III trial, which sent Merck shares up more than 9%, were so strong that the study is being stopped early at the recommendation of outside monitors.

Shares of Atea Pharmaceuticals Inc, which is developing a similar COVID-19 treatment, were up more than 21% on the news.

Shares of COVID-19 vaccine makers https://www.reuters.com/business/healthcare-pharmaceuticals/Merck-covid-19-pill-success-slams-moderna-shares-shakes-up-healthcare-sector-2021-10-01 Moderna Inc were off more than 10%, while Pfizer was down less than 1%.

Jefferies analyst Michael Yee said investors believe “people will be less afraid of COVID and less inclined to get vaccines if there is a simple pill that can treat COVID.”

Pfizer and Swiss drugmaker Roche Holding AG are also racing to develop an easy-to-administer antiviral pill for COVID-19. For now, only antibody cocktails that have to be given intravenously are approved for non-hospitalized patients.

White House COVID-19 response coordinator Jeff Zients said on Friday that molnupiravir is “a potential additional tool… to protect people from the worst outcomes of COVID,” but added that vaccination “remains far and away, our best tool against COVID-19.”

A planned interim analysis of 775 patients in Merck’s study looked at hospitalizations or deaths among people at risk for severe disease. It found that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after treatment. That compared with a hospitalization rate of 14.1% for placebo patients. There were also eight deaths in the placebo group.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.

‘A HUGE ADVANCE’

Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world, 700,000 of them in the United States.

“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” said Peter Horby, a professor of emerging infectious diseases at the University of Oxford.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck has said similar studies of molnupiravir – for longer and at higher doses than used in humans – indicate that the drug does not affect mammalian DNA.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus including the highly transmissible Delta, which has driven the recent worldwide surge in hospitalizations and deaths.

It said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age in the study could be pregnant and also had to use birth control.

The U.S. drugmaker said it expects to produce 10 million courses of the treatment by the end of 2021.

The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

Davis said Merck has similar agreements with other governments, and is in talks with more. Merck said it plans a tiered pricing approach based on country income criteria.

The U.S. government has the option to purchase up to an additional 3.5 million treatment courses if needed, a U.S. health official told Reuters. The official asked to remain anonymous because they were not authorized to comment publicly on the contract.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase III trial for preventing infection in people exposed to the coronavirus.

Merck officials said it is unclear how long the FDA review will take, although Dean Li, head of Merck’s research labs, said, “they are going to try to work with alacrity on this.”

رويترز

قال خبراء إن دواء في صورة أقراص طورته شركة “ميرك” الأمريكية لصناعة الأدوية يمثل انفراجة في العلاج من فيروس كورونا نظرا لقدرته على خفض احتمالات الوفاة أو ضرورة النقل إلى المستشفى للنصف بالنسبة للأشخاص الأكثر عرضة للإصابة بالأعراض الحادة لكوفيد-19.

وفي حالة حصولها على الموافقات اللازمة، ستكون أقراص ملنوبيرافير، المصممة لزرع أخطاء في الشفرة الجينية للفيروس أول دواء مضاد للفيروسات يؤخذ عن طريق الفم لعلاج كوفيد-19.

وتخطط ميرك وشريكتها ريدجباك لمستحضرات العلاج الحيوية للحصول على إذن الاستخدام الطارئ في الولايات المتحدة بأسرع ما يُمكن وتقديم طلبات لهيئات تنظيم الدواء في مختلف أنحاء العالم.

وقال روبرت ديفيس الرئيس التنفيذي لشركة ميرك لرويترز إن هذا العلاج سيحدث تغييرا جذريا في أساليب السيطرة على كوفيد-19.

ومن بين الخيارات العلاجية الحالية ريميديسفير المضاد للفيروسات وتنتجه شركة جيلياد (NASDAQ:GILD) وديكساميثازون وهو عبارة عن ستيرويد، لكن لا يتم إعطاؤهما إلا بعد دخول المريض إلى المستشفى بالفعل.

قال أميش أداليا، الباحث الكبير في مركز جونز هوبكنز للأمن الصحي “ستتغير قواعد اللعبة بسبب مضادات الفيروسات التي تؤخذ بطريق الفم وتستطيع التأثير على خطر دخول المستشفى لهذا الحد”.

أضاف أداليا أن العلاجات الحالية “مرهقة وصعبة من الناحية اللوجستية. تناول قرص بسيط بطريق الفم سيكون عكس ذلك”.

وبسبب النتائج الإيجابية، ارتفعت أسهم ميرك بأكثر من 9 بالمئة في بداية التعاملات في نيويورك، وتوقفت تجربة في المرحلة الثالثة بناء على توصية من مراقبين خارجيين.

وانخفضت أسهم فايزر بنسبة 3 بالمئة وموديرنا بنسبة 10 بالمئة وهما شركتان مصنعتان للقاحات كوفيد-19، وهو ما علق عليه مايكل يي محلل التكنولوجيا الحيوية في جيفريز بالقول إنه يشير إلى اعتقاد المستثمرين بأن “الناس سيصبحون أقل خوفا من كوفيد وأقل ميلًا للحصول على اللقاحات في حالة وجود قرص بسيط يمكن أن يعالج المرض”.