Little Brown Pill
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Drugmakers see an opportunity to add to the arsenal of potential therapies. There are 246 antivirals in development, according to the Biotechnology Innovation Organization, an industry trade group. And companies as big as Pfizer Inc. and as little-known as Veru Inc. are testing them in pill form. Merck’s molnupiravir is among the furthest along. Its developers hope the pills can be prescribed widely to anyone who gets sick. Think Tamiflu for Covid.
The hurdle, beyond ensuring the drug works, is making sure it’s safe. Developers of antivirals have been dealing with the thorny issues they pose for decades. Should Merck succeed in demonstrating that molnupiravir is effective and free of serious side effects, it could be a boon to the company, and to society, for many years to come.
Viruses are uniquely difficult to attack with drugs. They hijack human cells and set up machinery to churn out copies of themselves, creating a challenge: destroying the virus without harming the cells. Success, when it comes, can be fleeting, because viruses mutate to survive.The chemical compound on which molnupiravir is based—C9H13N3O6, or N4-hydroxycytidine—has been known for decades. Like idoxuridine, the herpes drug, it’s a nucleoside analogue. It interferes in replication, preventing a threat from causing severe infection. Molnupiravir doesn’t stop the virus from replicating, though; instead, the drug introduces errors into the virus’s RNA that are then replicated until it’s defunct.
With antivirals such as this, “basically you’re going to put a piece of sand in the gears and hope it stops the impact of the virus,” says Gomez, the former Niaid scientist. But, he adds, stopping the virus by creating errors in the genetic code or through other means can come with unintended consequences. “You don’t know where the sand might end up in the other parts of the body.” A company called Pharmasset Inc. (a hepatitis C drugmaker Gilead bought in 2011) investigated molnupiravir’s main ingredient around the turn of the century, but it abandoned development over concerns that it was mutagenic, meaning it could lead to birth defects. -
I almost posted that yesterday. If it’s an effective across the board antiviral and is safe, Merck could still “win” this thing.
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Two Indian drugmakers have requested permission to end late-stage trials of their generic versions of Merck & Co's (MRK.N) oral antiviral drug molnupiravir for moderate COVID-19, raising questions about how effective the experimental medicine is for that group of patients.
The Indian drug regulator's internal expert committee disclosed on its website that Aurobindo Pharma Ltd (ARBN.NS) and MSN Laboratories had presented interim clinical trial data for this group of patients and asked to end the trials.
The two companies plan to continue their late-stage trials for patients with mild COVID-19, the drug regulator said.
A source with the Drug Controller General of India said the pill has not shown "significant efficacy" against moderate COVID-19, though it was having success against mild cases.
Merck and partner Ridgeback Biotherapeutics last week said molnupiravir had nearly halved the risk of hospitalization or death in patients at risk of severe disease who had mild-to-moderate COVID-19, results hailed by experts as potentially a major advance in fight against the illness.
It has not yet provided detailed data of its trial that had planned to enroll 1,500 patients.
It was not immediately clear whether differences between the trials run by the Indian drugmakers and Merck - such as how they define moderate COVID-19 - may have contributed to the trial outcomes. According to Aurobindo's trial protocol, moderate patients included those with fever, coughing, breathing difficulties and oxygen deficiency.
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https://phys.org/news/2023-09-anti-covid-drug-virus-mutations.html
Pharmaceutical giant Merck's antiviral pill molnupiravir was one of the earliest treatments rolled out during the pandemic to prevent COVID becoming more severe in vulnerable people.
The drug, which is taken orally over a five-day course, works mainly by creating mutations in the virus with the goal of weakening and killing it.
However, a new UK-led study has shown that molnupiravir "can give rise to significantly mutated viruses which remain viable," lead author Theo Sanderson told AFP.
Sanderson, a geneticist at London's Francis Crick Institute, emphasized that there is no evidence that "molnupiravir has to date created more transmissible or more virulent viruses."
None of the variants that have swept the world were due to the drug, he added.
But "it is very difficult to predict whether molnupiravir treatment could potentially lead to a new widely circulating variant which people don't have prior immunity to," he added.
"Now look here, you Baltic gas passer... " - Mik, 6/14/08
The saying, "Lite is just one damn thing after another," is a gross understatement. The damn things overlap.
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https://phys.org/news/2023-09-anti-covid-drug-virus-mutations.html
Pharmaceutical giant Merck's antiviral pill molnupiravir was one of the earliest treatments rolled out during the pandemic to prevent COVID becoming more severe in vulnerable people.
The drug, which is taken orally over a five-day course, works mainly by creating mutations in the virus with the goal of weakening and killing it.
However, a new UK-led study has shown that molnupiravir "can give rise to significantly mutated viruses which remain viable," lead author Theo Sanderson told AFP.
Sanderson, a geneticist at London's Francis Crick Institute, emphasized that there is no evidence that "molnupiravir has to date created more transmissible or more virulent viruses."
None of the variants that have swept the world were due to the drug, he added.
But "it is very difficult to predict whether molnupiravir treatment could potentially lead to a new widely circulating variant which people don't have prior immunity to," he added.
@George-K said in Little Brown Pill:
However, a new UK-led study has shown that molnupiravir "can give rise to significantly mutated viruses which remain viable," lead author Theo Sanderson told AFP.
Sanderson, a geneticist at London's Francis Crick Institute, emphasized that there is no evidence that "molnupiravir has to date created more transmissible or more virulent viruses."
Seem to be opposite opinions.
