Anti Covid pills, how Merck’s is going (and what it does with Irbm)
Here are the updated results of the Merck anti Covid pill and some rumors about the Italian biotechnology company Irbm
Merck and Ridgeback Biotherapeutics' anti-Covid pill, molnupiravir, has overcome one of the last hurdles in the United States. The Food and Drug Administration (FDA) panel of health advisors voted in favor of the antiviral drug, despite the trial's updated data showing a noticeable decline in efficacy.
The final decision of the FDA, which is not bound by the panel's recommendation, is now awaited by the end of the year.
THE OPINION OF THE PANEL
After hours of debate came the opinion of the committee that discussed the benefits and potential safety concerns related to the Merck pill.
In the end, according to the pharmaceutical company's website , the outcome was positive, with 13 votes in favor and 10 against.
THE FINAL DECISION
If approved by the FDA as well, molnupiravir would be the first antiviral against Covid that patients can take on their own, without needing to be hospitalized or subjected to medical surveillance.
This would ease the pressure on hospitals and reduce deaths.
TO WHOM IT IS RECOMMENDED
The Merck Pill is indicated for the treatment of Covid-positive adults in a mild to moderate form and who already have other problems – such as obesity, asthma or old age – that could aggravate the condition.
WHO IS NOT RECOMMENDED
The committee then added that the drug should not be taken by pregnant women and called on the FDA to recommend additional precautions – such as pregnancy tests for women before using the drug.
WHAT MERCK SAID
“With the continued spread of the virus and the emergence of variants, further treatments for Covid are urgently needed. That is why we are moving with speed and rigor to pursue clearances and to accelerate broad global access to this investigational drug, ”said Dr. Dean Y. Li , executive vice president and president of Merck Research Laboratories.
LESS EFFECTIVE THAN EXPECTED
The Phase 3 MOVe-OUT clinical trial demonstrated that Merck's pill halved the risk of hospitalization and death in at-risk patients, including in the Delta, Gamma and Mu variants.
The recent study update, however, reduced the drug's effectiveness by 50 to 30 percent. On November 26, Merck and Ridgeback Biotherapeutics said in a joint note that according to the study – which expanded from 775 patients in October to 1,433 – the pill had reduced the risk of hospitalization or death by 9.7 percent (versus 14.1 percent. of the interim study) while in the group that received placebo it decreased from 7.3% to 6.8%, with an absolute risk reduction of 3% (previously 6.8%) and a relative risk reduction of 30%, instead of 48%.
THE MERCK-IRBM PARTNERSHIP
Merck continues to embark on new projects, such as the one with the Italian biotechnology company Irbm, based in Pomezia. The two companies, as announced last year on the Irbm website , are working on "a new anti Covid drug in aerosol or injectable formulation, using a valid platform for adaptation to emerging variants".
WILL IRBM ALSO HAVE ITS ANTI COVID PILL?
The scientific director of Irbm Carlo Toniatti then reported two days ago to Ansa also about an internal research project on a new oral anti Covid pill: "it is focused on the development of a molecule capable of inhibiting one of the proteins essential for replication of the virus, other than the Spike protein, ”he said.
"The Spike protein – Toniatti clarified – is on the surface of the Sars-CoV-2 virus but to replicate itself, once inside the host organism, it needs various 'internal' proteins that are not affected by vaccines. current. Therefore, these are proteins that are used to make the virus replicate, but different from Spike ".
The goal, therefore, "is therefore to inhibit these internal proteins so that the virus cannot replicate once it is present in the cells of the host organism".
The studies, Toniatti concluded, "have begun and definitive data on feasibility are expected for 2023".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/pillole-anti-covid-come-va-quella-di-merck-e-cosa-fa-con-irbm/ on Wed, 01 Dec 2021 09:41:16 +0000.