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Believed to be the world’s first COVID-19 therapeutic created by generative AI, the drug will soon begin clinical trials, the Canadian-founded company announced. For the first time ever, a COVID-19 drug entirely designed by generative AI has been approved for human use and will soon begin clinical trials in China, the Canadian-founded company announced Thursday. The drug, named ISM3312, was discovered in a matter of months by multinational biotechnology company Insilico Medicine. Believed to be the world’s first COVID-19 therapeutic created by generative AI, one of the company’s CEOs claims the drug is already “as perfect as it can get,” according to initial tests. “I just don’t think it’s possible to make a better one, period,” said Alex Zhavoronkov, the Canadian founder and co-CEO of Insilico Medicine, told the Star. “The molecule is so stable... it is an absolutely novel molecule not found in any of the libraries” of known therapeutics. ISM3312 showed great promise during preclinical studies done on mice and isolated cells, able to significantly lower viral load in lung tissue and reduce lung inflammation. It can be taken orally or inhaled, is effective even at low doses and potentially has few side effects, the company said in a release. “If your molecule is very tolerable, and if you make very little of it available in the body and it still works, it’s perfect, right?” Zhavoronkov said. ISM3312 works by inhibiting a protein called 3CL protease — a critical factor in viral replication and a popular target for anti-COVID drugs. Unlike similar therapeutics, however, Zhavoronkov said his drug works on a very broad spectrum — showing efficacy not only against all current COVID variants, but also coronaviruses other than SARS-CoV-2. As such, it may possess the ability to resist future mutations, providing a solution to drug-resistant strains, he continued. “You can also use it potentially for prevention,” Zhavoronkov said — because the 3CL protease target is only present in viruses, it should be safe to take when otherwise healthy. The company started work on the drug in early 2020, back near the start of the pandemic. They began by slotting the 3D structure of 3CL protease into one of their in-house AI programs; within a matter of days, the model was able to generate about 20 different potential drug candidates from scratch. In contrast, traditional drug discovery pipelines can take years or even decades to find one suitable therapeutic. “The beauty of generative AI (in drug discovery) is instead of searching for a needle in a haystack, it generates a bunch of perfect needles for you,” Zhavoronkov said. “Then you just have to choose from those perfect needles — if you want the longer one or the one that is more stable.” By February of 2020, Insilico had published their first set of drug candidates online; by April, they’d filed a related patent application. But it wouldn’t be until recently that they’d receive approval to start clinical trials. “Unfortunately, at that time, you probably remember everybody was running around with their heads on fire, right?” Zhavoronkov said. Insilico, still a relatively small company at the time, had difficulty finding a partner interested in their product. “Some big pharmas thought that COVID was going to go away very quickly, some big pharmas thought vaccines will solve the problem and some big pharmas didn’t even believe there was a pandemic for a while,” he continued. “And at that time we were not exactly very well funded.” The project was further stalled in 2021 due to the limited availability of COVID-19 viruses for use in testing, with governments and big pharmaceutical companies given priority. Insilico used the delay to refine and improve on their drug candidates, eventually narrowing the list down to just one: ISM3312. While frustrating, Zhavoronkov admitted the delay inadvertently led to the discovery of his “perfect” drug and its subsequent approval for human use by the China National Medical Products Administration. That said, had all the resources been available at the start, Zhavoronkov said “I can probably do it all again in under a year.” The company hasn’t given a start date or timeline for the clinical trials, though it promises to start “soon.” “There remains an urgent need for conducting well-designed clinical trials for scientific evaluation of potential COVID-19 therapies such as ISM3312,” said Dr. Sujata Rao, Insilico’s senior vice-president and head of clinical development, in a release. “We are committed to exploring ongoing unmet medical needs to include subgroups under-represented in COVID-19 trials as well as in patients who may have variants that are more resistant to antiviral drugs.” Insilico isn’t the only company utilizing AI to treat COVID-19, but they may be the furthest along. For example, company Exscientia AI limited is currently in the discovery phase of a new COVID drug using a different AI system, in a project wholly backed by the Bill and Melinda Gates Foundation. Given the promise of their new drug, Zhavoronkov said it may be a “very long time,” if ever, before Insilico looks at making another COVID-19 therapeutic. “It might make sense developing maybe one more drug for COVID, also AI generated. But that would come much later — it will take a while for resistance to develop against mine.”
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The study will now assess the tolerability and safety of multiple ascending doses of PF-07321332, an oral antiviral agent against SARS-CoV-2. The study will now assess the tolerability and safety of multiple ascending doses of PF-07321332, Pfizer’s investigational oral antiviral agent against SARS-CoV-2. Pfizer is progressing its novel oral antiviral candidate against SARS-CoV-2 into multiple ascending doses after completing the dosing of single ascending doses in a Phase I study in healthy adults. The trial is evaluating the safety and tolerability of PF-07321332, a SARS-CoV2-3CL protease inhibitor, which demonstrated potent in vitro antiviral activity against SARS-CoV-2 and other coronaviruses. SARS-CoV-2 is the virus that causes COVID-19. “Tackling the COVID-19 pandemic requires both prevention via vaccine and targeted treatment for those who contract the virus. Given the way that SARS-CoV-2 is mutating and the continued global impact of COVID-19, it appears likely that it will be critical to have access to therapeutic options both now and beyond the pandemic,” stated Dr Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical of Pfizer. “We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalised or in critical care. At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalised patients. Together, the two have the potential to create an end-to-end treatment paradigm that complements vaccination in cases where disease still occurs.” Protease inhibitors such as PF-07321332 bind to a viral enzyme, called a protease, which is vital for the virus to successfully replicate in human cells. Through their interaction with the enzyme, this class of medicines prevent the virus from replicating. Protease inhibitors have been used to treat various other viral pathogens, including HIV and hepatitis C virus, both alone and in combination with other antivirals. Currently marketed protease inhibitors are not generally associated with toxicity and as such, this class of molecules may potentially provide well-tolerated treatments against COVID-19. The Phase I trial is a randomised, double-blind, sponsor-open, placebo-controlled, single- and multiple-dose escalation study in healthy adults evaluating the safety, tolerability and pharmacokinetics of PF-07321332. Pfizer is also investigating an intravenously administered investigational protease inhibitor, PF-07304814, in a Phase Ib multi-dose trial in hospitalised patients with COVID-19. Pfizer Press Release (March 23, 2021): https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-phase-1-study-novel-oral-antiviral
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The main protease, Mpro (or 3CLpro) in SARS-CoV-2 is a viable drug target because of its essential role in the cleavage of the virus polypeptide. Feline infectious peritonitis, a fatal coronavirus infection in cats, was successfully treated previously with a prodrug GC376, a dipeptide-based protease inhibitor. Here, we show the prodrug and its parent GC373, are effective inhibitors of the Mpro from both SARS-CoV and SARS-CoV-2 with IC50 values in the nanomolar range. Crystal structures of SARS-CoV-2 Mpro with these inhibitors have a covalent modification of the nucleophilic Cys145. NMR analysis reveals that inhibition proceeds via reversible formation of a hemithioacetal. GC373 and GC376 are potent inhibitors of SARS-CoV-2 replication in cell culture. They are strong drug candidates for the treatment of human coronavirus infections because they have already been successful in animals. The work here lays the framework for their use in human trials for the treatment of COVID-19. Coronavirus main protease is essential for viral polyprotein processing and replication. Here Vuong et al. report efficient inhibition of SARS-CoV-2 replication by the dipeptide-based protease inhibitor GC376 and its parent GC373, which were originally used to treat feline coronavirus infection. Published in Nature Commun. (August 27, 2020): https://doi.org/10.1038/s41467-020-18096-2
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Japanese pharmaceutical firm Shionogi & Co said Friday it has applied for approval of its oral COVID-19 drug, after mid-phase clinical trials showed efficacy in reducing the coronavirus in the body. It is the first such pill developed by a Japanese drugmaker and will be administered to mild-to-moderate coronavirus patients, regardless of whether they are at risk of hospitalization, to prevent the virus from multiplying in the body. The Osaka-based firm said it had filed with the Health, Labor and Welfare Ministry for conditional early approval of the drug known as S-217622, following the results of phase-2 clinical trials. The conditional early approval system allows drugmakers to skip the final stage of clinical trials once a certain level of efficacy and safety has been confirmed, according to the health ministry. The system applies in cases where effective treatments for a disease are scarce and clinical trials may be protracted due to few test subjects. Trials were conducted with a focus on people who became infected since the spread of the Omicron variant, Shionogi said in a press release. During the process, patients took one dose of the drug daily over a period of five days and were found to show rapid reductions in viral load and improvement in symptoms compared with those who were given a placebo. Shionogi has said it can start supplying between 400,000 and 500,000 doses of the drug in Japan by the end of February and 1 million doses by the end of March. The firm is known for its infectious diseases treatments, such as influenza drug Xofluza and Tivicay for HIV. In May 2020, the health ministry approved remdesivir, an anti-viral intravenous drug developed by U.S. firm Gilead Sciences Inc., three days after the company applied for emergency authorization of the treatment. The oral COVID-19 drug Molnupiravir was granted special approval in December 2021, around 20 days after U.S. pharmaceutical firm Merck & Co filed its application.
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Now, a new study by researchers from Pfizer, University of Arizona, Purdue University, The Scripps Research Institute, and UC San Diego School of Medicine and published on the preprint server bioRxiv in September 2020 reports that an enzyme inhibitor may act in synergism with the approved antiviral remdesivir to suppress viral replication in COVID-19. Remdesivir is an RNA-dependent RNA polymerase (RdRp) inhibitor that has received emergency use authorization by the US Food and Drug Administration (FDA) in May 2020 for the treatment of SARS-CoV-2. Remdesivir trials have revealed that this drug reduces the time to recovery for COVID-19 patients, but not the severity of the disease. To enhance its clinical impact, it is necessary to find other drugs that may add to its therapeutic efficacy. The drug candidate PF-00835231 discussed in the current study acts on the SARS-CoV-2 main protease or 3C-like protease (3CL protease or 3CLpro). This is required for viral replication since it causes the large viral polyprotein p1a/p1ab to be cleaved at 10 or more junctions. The result is the production of several non-structural proteins that play a crucial part in viral replication and transcription. These include RdRp, the helicase, and the 3CLpro itself. Also, viral 3CLpro has no comparable human analogs. These two properties make it an ideal candidate for further investigation as a potential COVID-19 therapeutic. Protease inhibitors have played a similar role in HIV and HCV therapeutics. Following this lead, the current researchers identified a small molecule protease inhibitor PF-00835231 that was active against SARS-CoV, the virus responsible for the earlier respiratory illness outbreak of 2002. Produced by structure-based drug design, this drug never saw the light of day because of the rapid termination of the outbreak by stringent public health measures. Now, the researchers are taking a fresh look at it because of the high degree of identity between the SARS-CoV and SARS-CoV-2 3CLpro. In fact, they have entirely identical active sites. The researchers found that both PF-00835231 and its phosphate prodrug has antiviral activity against a broad spectrum of coronaviruses (CoVs). It binds tightly to the enzyme at the catalytic cysteine residue, potently suppressing its activity. This enzyme being conserved across several CoVs. This allows it to inhibit several CoV 3CLpro enzymes in vitro, from alpha-, beta- and gamma-CoVs. However, it is inactive against human and HIV proteases, indicating its specificity of activity. The researchers examined the ability of PF-00835231 to exert antiviral activity against SARS-CoV-2 in cell culture, using a cytopathic effect (CPE) assay. As expected from experience with other viral protease inhibitors, they found that there was a dose-dependent but steep suppression of viral activity with this molecule. When repeated using cell lines, which are more similar to the human lung cells, they obtained similarly promising results. Thus, this drug candidate has in vitro antiviral activity even as a single agent. When antiviral agents are combined, especially when they act on different steps of the replication cycle, the effects are often much more significant than when used alone. Evaluation of the combined activity of these drugs led to the finding that while the in vitro EC50 for PF-00835231 alone was 0.14 μM, and for remdesivir, it was 0.074μM, in combination, they showed a mix of synergistic and additive effects. This could be because different convalescent sera were used for the detection process... Preprint available at bioRxiv (Sept.13, 2020): https://www.biorxiv.org/content/10.1101/2020.09.12.293498v2
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Yunjeong Kim and Kyeong-Ok "KC" Chang, virologists in the College of Veterinary Medicine at Kansas State University, have published a study showing a possible therapeutic treatment for COVID-19. Pathogenic coronaviruses are a major threat to global public health, as shown by severe acute respiratory syndrome coronavirus, or SARS-CoV; Middle East respiratory syndrome coronavirus, known as MERS-CoV; and the newly emerged SARS-CoV-2, the virus that causes COVID-19 infection. The study, "3C-like protease inhibitors block coronavirus replication in vitro and improve survival in MERS-CoV-infected mice," appears in the Aug. 3 issue of the prestigious medical journal Science Translational Medicine. It reveals how small molecule protease inhibitors show potency against human coronaviruses. These coronavirus 3C-like proteases, known as 3CLpro, are strong therapeutic targets because they play vital roles in coronavirus replication. Vaccine developments and treatments are the biggest targets in COVID-19 research, and treatment is really key," said Chang, professor of diagnostic medicine and pathobiology. "This paper describes protease inhibitors targeting coronavirus 3CLpro, which is a well-known therapeutic target." The study demonstrates that this series of optimized coronavirus 3CLpro inhibitors blocked replication of the human coronaviruses MERS-CoV and SARS-CoV-2 in cultured cells and in a mouse model for MERS. These findings suggest that this series of compounds should be investigated further as a potential therapeutic for human coronavirus infection. Chang and Kim have been using National Institutes of Health grants to develop antiviral drugs to treat MERS and human norovirus infections. Their work extends to other human viruses such as rhinoviruses and SARS-CoV-2... Original study published in Science Translational Medicine (Aug. 3, 2020): https://doi.org/10.1126/scitranslmed.abc5332
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https://acquistaossicodoneitalia.com/negozio/acquista-quaaludes-in-linea/
Acquista Online La Prescrizione Di Perdita Di Peso
Crediamo che i farmaci a volte possano essere molto urgenti da assumere. Se hai urgente bisogno di farmaci, possiamo anche fornirti una consegna espressa,
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