Investorideas.com

Get investor ideas from our AI, cannabis, cleantech, crypto, gaming, mining, sports podcasts - be a guest or sponsor: call 800 665 0411


Share on StockTwits

Merck and Ridgeback Post Interim Data From Phase 3 Antiviral Drug Trial Showing 50% Reductions in Hospitalizations and Deaths in Mild and Moderate COV

Source: Streetwise Reports

 

October 4, 2021 (Investorideas.com Newswire) Shares of Merck & Co. Inc. traded 9% higher after the company reported that in a global Phase 3 clinical trial conducted together with its partner Ridgeback Biotherapeutics, oral antiviral molnupiravir reduced risk of hospitalization or death by 50% versus placebo in patients with mild or moderate COVID-19. Merck plans to submit an Emergency Use Authorization application to the U.S. FDA and if authorized it would make molnupiravir the first approved oral antiviral medicine for COVID-19.


Global healthcare giant Merck & Co. Inc. (MRK:NYSE), known as MSD outside of the U.S. and Canada, which manufactures and markets biologic therapies, prescription medicines, vaccines and animal health products worldwide and Ridgeback Biotherapeutics L.P., today announced that "molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19."

The companies stated that data from a planned interim analysis in the Phase 3 MOVe-OUT study demonstrated that molnupiravir significantly reduced the risk of hospitalization or death by around 50%. The firms advised that 7.3% of the 385 patients who were administered molnupiravir were either hospitalized or had died through Day 29 of observation compared to 14.1% of the 377 individuals in the placebo group.

The companies noted that through 29 days of commencing treatment, there were zero deaths reported in patients who received molnupiravir, though 8 deaths were recorded in patients who received placebo.

Importantly, an independent Data Monitoring Committee recommended in consultation with the U.S. Food and Drug Administration (FDA), that the enrollment in the clinical trial should cease due to the highly positive results observed in the randomized cohort who were given molnupiravir.

Based upon the strong positive findings Merck & Co. intends to quickly expedite the submission of an application for Emergency Use Authorization (EUA) to the FDA and is also formulating plans to submit marketing applications to other worldwide regulatory bodies. The companies highlighted that "if authorized, molnupiravir could be the first oral antiviral medicine for COVID-19."

Merck's CEO and President Robert M. Davis commented, "More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world. With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck's unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most…we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible."

Ridgeback Biotherapeutics' CEO Wendy Holman remarked, "With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed."

"We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved and we appreciate the collaborative effort to reach this important stage of development," CEO Holman added.

The preplanned interim analysis evaluated data from 775 patients in the Phase 3 MOVe-OUT trial. The trial initially planned for enrollment of 1,550 patients and was about 90% enrolled when the decision was made to stop recruiting participants in the study based upon the positive interim findings.

The Phase 3 MOVe-OUT trial was conducted at over 170 sites in more than 20 countries in the Americas, Europe, Asia and Africa. To be included in the study, patients must have been diagnosed with laboratory-confirmed mild-to-moderate COVID-19 and have presented symptom(s) onset within five days of study randomization. Additionally, only those individuals who had at least one risk factor associated with poor disease outcome were at admitted to join the study. These higher risk factors included diabetes mellitus, heart disease, obesity and older age (>60 years).

The companies reported that that interim data showed that "molnupiravir reduced the risk of hospitalization and/or death across all key subgroups and efficacy was not affected by either timing of symptom onset or underlying risk factor." The report mentioned that molnupiravir was showed consistent efficacy across the Gamma, Delta and Mu variants in 40% of participants where viral sequencing data was available.

In the expectation and hope that the FDA grants EUA approval for molnupiravir, Merck indicated that it has already commenced production of molnupiravir at its own risk and plans to manufacture 10 million courses of treatment by year-end 2021 along with many more additional doses in 2022.

The report advised that Merck entered into a procurement agreement earlier this year to supply approximately 1.7 million courses of molnupiravir to the U.S. Government, upon EUA or FDA approval. The company also has also entered into supply and purchase agreements for molnupiravir with some other governments outside of the U.S.

Molnupiravir (MK-4482/EIDD-2801) was described in the report as "an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. The drug was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University and is being developed by Merck & Co. Inc. in collaboration with Ridgeback Biotherapeutics." Molnupiravir has also been studied in other animal models to investigate potential use in treatment of Ebola, Equine Encephalitis, Influenza and Respiratory Syncytial Virus.

Ridgeback Biotherapeutics is a private biotechnology company based in Miami, Fla. The firm focuses on developing treatments for emerging infectious diseases. Ridgeback listed that "it markets EbangaTM for the treatment of Ebola and has a late-stage development pipeline which includes molnupiravir for the treatment of COVID-19."

Merck is headquartered in Kenilworth, N.J., and is one of the world's largest global healthcare companies with a market cap of around $190 billion. The firm is known as MSD outside of the U.S. and Canada. The company provides healthcare services and develops, manufactures and markets animal health products, biologic therapies, prescription medicines and vaccines worldwide. The company stated that it endeavors to be "the premier research-intensive biopharmaceutical company in the world."

Merck started Friday with a market cap around $190.1 billion with approximately 2.531 billion shares outstanding and a short interest of about 1.1%. MRK shares opened over 8% higher at $81.56 (+$6.45, +8.59%) over Thursday's $75.11 closing price and reached a new 52-week high price Friday morning of $84.34. The stock traded Friday between $80.63 and $84.34 per share and closed at $81.40 (+$6.29, +8.37%).

Disclosure:

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

More Info:

Investorideas.com Newswire

This news is published on the Investorideas.com Newswire - a global digital news source for investors and business leaders


Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions.

More disclaimer info: https://www.investorideas.com/About/Disclaimer.asp Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com

Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp


Follow Us on StockTwits






BiotechIndustryStocks.com - A Leading Global Investor Website for Biotech Industry Stocks

BiotechIndustryStocks.com - investing ideas in biotechnology stocks, medical technology and life sciences

Like Biotech Stocks? View our Biotech Stocks Directory

Get News Alerts on Biotech Stocks

Buy a biotech guest post on Investorideas.com