The only apples to apples comparison of The Merck/Ridgeback drug compared to Brilacidin is in regards to treating Moderate to Severe CV19 patients. The Merck drug failed as it was unable to show efficacy in a FDA human trial designed to treat Moderate/Severe CV19 population. IPIX will announce Brilacidin data for the treatment of Moderate/Severe CV19 later this month.
The Merck drug has serious safety issues in regards to its mutagenic properties.
I question the benefit of the Merck drug that is not safe and only potentially effective in the early stages of the disease. In fairness I will give due credit for the Merck drug being easily administered via pill formulation, but then again so is cyanide.
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There is currently not an effective antiviral therapeutic for hospitalized CV19 patients. IMO there will still not be a valid alternative or direct competitor to Brilacidin once it is approved for moderate/severe CV19 patients.
Brilacidin Safety – Safely administered in over 500 patients in multiple phase 2 trials for ABSSSI via IV, OM via oral rinse, IBD via water enema. Selectivity Index of 426 in RBL testing. Soon to be released B-CV19 human trial of 60/120 patients with 3-5 days of dosing. Compassionate Use for critical patients.
Brilacidin Effectiveness – Antiviral, antibiotic and anti-inflammatory properties. Direct interruption of viral integrity is considered a potent virucidal property.
IMO, Brilacidin will first prove itself as the ONLY antiviral therapeutic that is both safe and effective to treat hospitalized moderate to severe CV19 patients by eliminating the CV19 virus while protecting the patient by managing or modulating the human immune response allowing the patient to recover. IMO Brilacidin will prove to ELIMINATE the CV19 virus (not simply reduce viral load). This will be dose dependent based on when the patient gets treated during the disease process. The dosing profile may end up eventually needing for example 1-2 treatments for mild, 3-4 for moderate, 5 for severe and possibly 5+ for intubated critical patients. IMO if Brilacidin were to be administered early in the disease process there would be zero deaths directly associated due to the CV19 virus. Waiting for remdesivir or other SOC treatments to fail and then trying Brilacidin late in the illness is not a good strategy. Prior to CV19, intubated patients had around a 50% chance at survival. When NYC was at its CV19 peak, percentages dropped to a 20% survival rate. When Brilacidin advances from Compassionate Use to Emergency Use there will be many lives saved.
Brilacidin could initially be approved in the U.S. as a combination drug with remdesivir for strictly political reasons. Globally remdesivir is not considered a valid SOC so again IMO Brilacidin should be positioned internationally as the new standalone SOC for severe CV19 hospitalized patients.
Other CV19 treatments:
Remdesivir – We have beaten this horse to death but the FDA has admittedly acknowledged that remdesivir does not have mortality or viral load reduction benefits. The FDA approved this drug by justifying a reduction in hospital days. Safety is also questionable which has been covered in many Justfactsmam and farrell posts. Remdesivir is the only antiviral approved for moderate/severe CV19 patient treatment. IMO the bar is set very low for Brilacidin to be acknowledged as a far superior antiviral drug and will become the new SOC for moderate/severe CV19 patients. There are no legitimate competitors in this space that I am aware of.
Monoclonal Antibodies – Bind to the spike protein and are helpful in limiting viral replication. They do not kill the existing virus in the patient and do not have virucidal properties. Much like antivirals the earlier in the disease process that they are administered, the more likely they will have a positive impact and can be useful having anti-inflammatory properties.
AND Finally Drumroll Please… The “Gamechanger” from Merck/Ridgeback – 50% improvement and pill form! What could possibly go wrong?
Safety- As stated in falcon74 post #70492 per Justfactsmam: "Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, abandoned it in 2003 after discovering its mutagenic properties. “You don’t develop a drug that’s mutagenic. Period.” Hmmm.
What did Merck have to say in regards to the current trial inclusion criteria?
Recruitment required at least one underlying medical condition like obesity, old age (>60 years), diabetes, or heart disease. Looking at this patient population was needed to obtain statistical significance because too many with no underlying conditions just get better on their own. The trial could have been a failure otherwise. Another factor contributing to Merck's success is a smaller than expected stratification of Delta variant infections. Only 40% of the clinical trial had Delta variant patients. People need to consider that a majority of the data was from the alpha variant which means that if Merck doesn't segregate the data by variant they are trying to pull the wool over our eyes to hide how weak the data really is.
Criteria:
Is male and willing to be abstinent from heterosexual intercourse or use acceptable contraception during the study and for ≥4 days after the last dose of study intervention
Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse.
Is it just me or does this not sound very safe? Mutagenic properties causing the abandonment of this drug almost 20 years ago on a 40 year old drug that has never been approved? What is the risk factor for cancer or other serious results from taking a drug for MILD COVID?
Per farrell post #70504 “Molnupiravir has a positive Ames test which screens for genetic and fetal toxicity, (You probably don’t want your test subjects having sex or nursing while taking a mutagenic drug. It’s probably best to keep the cancer and other potential diseases to yourself).
Safety: Mutagenic with concerns over birth defects and cancer.
The drug is using the virus’s propensity to mutate against itself by tricking the replication machinery to pump out reproduction errors until the virally infected cell collapses. Molnupiravir was originally studied in the same coronavirus lab at Vanderbilt University that had studied remdesivir. The two drugs work by a similar mechanism, targeting the central enzyme coronaviruses use to copy their DNA. But molnupiravir has a different effect on the enzyme. Instead of blocking it, like the Gilead drug does, molnupiravir sends it into “error catastrophe” — forcing the virus to make so many copying mistakes that it can’t survive.
Efficacy: Merck is saying that the Ridgeback drug improves mortality and hospitalization by 50% over placebo. Quoting from when Merck gave up on Moderate/Severe hospitalized patients where they couldn’t play with the facts;
"Based on an interim analysis of data from the phase 2, dose-finding portion (Part 1) of 2 ongoing phase 2/3 trials evaluating molnupiravir, Merck and Ridgeback Biotherapeutics have decided to halt the MOVe-IN study for hospitalized COVID-19 patients and proceed with the phase 3 portion (Part 2) of the MOVe-OUT study in outpatients with COVID-19"
The pill known as molnupiravir reduced virus levels in patients during a mid-stage study but didn’t show a meaningful benefit in preventing hospitalizations and deaths , the Kenilworth, New Jersey-based company said in a statement. It decided to discontinue its development for the sickest patients, those hospitalized with the infection, after the trial showed it was unlikely to help them.
Merck MRK 8.37% & Co. and its partner Ridgeback Biotherapeutics LP said they are stopping a trial of their experimental Covid-19 drug after it failed to help hospitalized patients, delivering another setback to doctors seeking treatments to use for the disease.”
Big Pharma is not stupid. Once Brilacidin proves to be the safe and effective treatment of choice, BP will want to license it initially for Moderate/Severe CV19. The next step will be a general use delivery via pill, inhaler or depo injection to go after the mild CV19 and much larger general purpose antiviral/antibiotic/anti inflammation market. Brilacidin will have a huge advantage with a drug that is much safer than other antivirals and actually kills CV19 and other viruses and bacterial infections. Which drug would you take?
I was hoping to keep this post brief as the paid soft bashers have complained that my posts are too long but I have tried to make my posts Factually Uniform (FU). So to the criminally paid soft bashers that read this post in its entirety, I say FU.
https://www.empr.com/home/news/molnupiravir-m...treatment/
https://www.zerohedge.com/news/2021-10-01/mer...ZQ3qtIKmq4
https://bgr.com/2020/07/31/coronavirus-cure-m...ontroversy
https://www.empr.com/home/news/molnupiravir-m...treatment/
The Merck drug has serious safety issues in regards to its mutagenic properties.
I question the benefit of the Merck drug that is not safe and only potentially effective in the early stages of the disease. In fairness I will give due credit for the Merck drug being easily administered via pill formulation, but then again so is cyanide.
===========================================
There is currently not an effective antiviral therapeutic for hospitalized CV19 patients. IMO there will still not be a valid alternative or direct competitor to Brilacidin once it is approved for moderate/severe CV19 patients.
Brilacidin Safety – Safely administered in over 500 patients in multiple phase 2 trials for ABSSSI via IV, OM via oral rinse, IBD via water enema. Selectivity Index of 426 in RBL testing. Soon to be released B-CV19 human trial of 60/120 patients with 3-5 days of dosing. Compassionate Use for critical patients.
Brilacidin Effectiveness – Antiviral, antibiotic and anti-inflammatory properties. Direct interruption of viral integrity is considered a potent virucidal property.
IMO, Brilacidin will first prove itself as the ONLY antiviral therapeutic that is both safe and effective to treat hospitalized moderate to severe CV19 patients by eliminating the CV19 virus while protecting the patient by managing or modulating the human immune response allowing the patient to recover. IMO Brilacidin will prove to ELIMINATE the CV19 virus (not simply reduce viral load). This will be dose dependent based on when the patient gets treated during the disease process. The dosing profile may end up eventually needing for example 1-2 treatments for mild, 3-4 for moderate, 5 for severe and possibly 5+ for intubated critical patients. IMO if Brilacidin were to be administered early in the disease process there would be zero deaths directly associated due to the CV19 virus. Waiting for remdesivir or other SOC treatments to fail and then trying Brilacidin late in the illness is not a good strategy. Prior to CV19, intubated patients had around a 50% chance at survival. When NYC was at its CV19 peak, percentages dropped to a 20% survival rate. When Brilacidin advances from Compassionate Use to Emergency Use there will be many lives saved.
Brilacidin could initially be approved in the U.S. as a combination drug with remdesivir for strictly political reasons. Globally remdesivir is not considered a valid SOC so again IMO Brilacidin should be positioned internationally as the new standalone SOC for severe CV19 hospitalized patients.
Other CV19 treatments:
Remdesivir – We have beaten this horse to death but the FDA has admittedly acknowledged that remdesivir does not have mortality or viral load reduction benefits. The FDA approved this drug by justifying a reduction in hospital days. Safety is also questionable which has been covered in many Justfactsmam and farrell posts. Remdesivir is the only antiviral approved for moderate/severe CV19 patient treatment. IMO the bar is set very low for Brilacidin to be acknowledged as a far superior antiviral drug and will become the new SOC for moderate/severe CV19 patients. There are no legitimate competitors in this space that I am aware of.
Monoclonal Antibodies – Bind to the spike protein and are helpful in limiting viral replication. They do not kill the existing virus in the patient and do not have virucidal properties. Much like antivirals the earlier in the disease process that they are administered, the more likely they will have a positive impact and can be useful having anti-inflammatory properties.
AND Finally Drumroll Please… The “Gamechanger” from Merck/Ridgeback – 50% improvement and pill form! What could possibly go wrong?
Safety- As stated in falcon74 post #70492 per Justfactsmam: "Raymond Schinazi, an Emory University chemist who has extensively studied the active ingredient in EIDD-2801 but has no connection to DRIVE, abandoned it in 2003 after discovering its mutagenic properties. “You don’t develop a drug that’s mutagenic. Period.” Hmmm.
What did Merck have to say in regards to the current trial inclusion criteria?
Recruitment required at least one underlying medical condition like obesity, old age (>60 years), diabetes, or heart disease. Looking at this patient population was needed to obtain statistical significance because too many with no underlying conditions just get better on their own. The trial could have been a failure otherwise. Another factor contributing to Merck's success is a smaller than expected stratification of Delta variant infections. Only 40% of the clinical trial had Delta variant patients. People need to consider that a majority of the data was from the alpha variant which means that if Merck doesn't segregate the data by variant they are trying to pull the wool over our eyes to hide how weak the data really is.
Criteria:
Is male and willing to be abstinent from heterosexual intercourse or use acceptable contraception during the study and for ≥4 days after the last dose of study intervention
Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method), or is a WOCBP who is abstinent from heterosexual intercourse.
Is it just me or does this not sound very safe? Mutagenic properties causing the abandonment of this drug almost 20 years ago on a 40 year old drug that has never been approved? What is the risk factor for cancer or other serious results from taking a drug for MILD COVID?
Per farrell post #70504 “Molnupiravir has a positive Ames test which screens for genetic and fetal toxicity, (You probably don’t want your test subjects having sex or nursing while taking a mutagenic drug. It’s probably best to keep the cancer and other potential diseases to yourself).
Safety: Mutagenic with concerns over birth defects and cancer.
The drug is using the virus’s propensity to mutate against itself by tricking the replication machinery to pump out reproduction errors until the virally infected cell collapses. Molnupiravir was originally studied in the same coronavirus lab at Vanderbilt University that had studied remdesivir. The two drugs work by a similar mechanism, targeting the central enzyme coronaviruses use to copy their DNA. But molnupiravir has a different effect on the enzyme. Instead of blocking it, like the Gilead drug does, molnupiravir sends it into “error catastrophe” — forcing the virus to make so many copying mistakes that it can’t survive.
Efficacy: Merck is saying that the Ridgeback drug improves mortality and hospitalization by 50% over placebo. Quoting from when Merck gave up on Moderate/Severe hospitalized patients where they couldn’t play with the facts;
"Based on an interim analysis of data from the phase 2, dose-finding portion (Part 1) of 2 ongoing phase 2/3 trials evaluating molnupiravir, Merck and Ridgeback Biotherapeutics have decided to halt the MOVe-IN study for hospitalized COVID-19 patients and proceed with the phase 3 portion (Part 2) of the MOVe-OUT study in outpatients with COVID-19"
The pill known as molnupiravir reduced virus levels in patients during a mid-stage study but didn’t show a meaningful benefit in preventing hospitalizations and deaths , the Kenilworth, New Jersey-based company said in a statement. It decided to discontinue its development for the sickest patients, those hospitalized with the infection, after the trial showed it was unlikely to help them.
Merck MRK 8.37% & Co. and its partner Ridgeback Biotherapeutics LP said they are stopping a trial of their experimental Covid-19 drug after it failed to help hospitalized patients, delivering another setback to doctors seeking treatments to use for the disease.”
Big Pharma is not stupid. Once Brilacidin proves to be the safe and effective treatment of choice, BP will want to license it initially for Moderate/Severe CV19. The next step will be a general use delivery via pill, inhaler or depo injection to go after the mild CV19 and much larger general purpose antiviral/antibiotic/anti inflammation market. Brilacidin will have a huge advantage with a drug that is much safer than other antivirals and actually kills CV19 and other viruses and bacterial infections. Which drug would you take?
I was hoping to keep this post brief as the paid soft bashers have complained that my posts are too long but I have tried to make my posts Factually Uniform (FU). So to the criminally paid soft bashers that read this post in its entirety, I say FU.
https://www.empr.com/home/news/molnupiravir-m...treatment/
https://www.zerohedge.com/news/2021-10-01/mer...ZQ3qtIKmq4
https://bgr.com/2020/07/31/coronavirus-cure-m...ontroversy
https://www.empr.com/home/news/molnupiravir-m...treatment/
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