African-American Scientist Develops ENU200 Drug to Treat COVID-19
African-American Scientist Develops ENU200 Drug to Treat COVID-19
By TaShia Asanti
Across America in early 2020, people began arriving in hospital emergency rooms with alarming symptoms. While it was initially assumed the symptoms were caused by a new strain of influenza, doctors soon realized they were dealing with something different. The infection rate skyrocketed. Numerous victims of the mysterious illness were admitted to hospitals, many directly into intensive care units.
Tragically, the Trump Administration downplayed the virus, telling Americans it would be gone by April 2020. As the numbers continued to soar, scientists worked frantically to track the origin of the virus and stop what they feared would become an epidemic. The virus was traced back to a research lab in Wuhan, China and later classified by the International Committee on Taxonomy of Viruses as SARS-CoV-2 i.e. the novel coronavirus. In February 2020, the World Health Organization gave the virus the name COVID-19.
Researchers declared that COVID-19 was not only highly infectious but noted a dangerous replicating factor that had the power to overwhelm an immune system in days. This RNA factor made the virus virtually unstoppable, potentially decimating healthy blood cells and shutting down major organs like the lungs, kidney and liver. Medical experts raced against time to respond to an illness that was circumventing the globe.
Hospitals would be flooded with patients, some of whom had to be intubated to stay alive. The medicines that seemed to help patients had horrendous side effects and took too long to work. By the summer of 2020, mega pharmaceutical companies Pfizer and Moderna took the lead in developing vaccines. Meanwhile, scientist Darnisha Harrison and a team of researchers developed ENU200, a medicine that was showing success as a treatment for COVID-19.
Harrison, the founder and CEO of Ennaid Therapeutics, said, "After graduating from Louisiana State University, I landed my dream job at Georgia State University as a microbiologist. I also spent several years at Amgen, an international biotechnology firm and 16 years working in pharmaceutical research. That experience prepared me to develop the ENU200 drug, a medicine we believe is extremely promising in helping save the lives of people infected with COVID-19."
Harrison also spoke on myths about COVID-19 and what makes the disease so dangerous to some.
"We know that 80% of COVID-19 cases range from mild, moderate to asymptomatic. Most people's immune systems are able to fight off the disease and help the person fully recover. It's not that COVID-19 itself is so very deadly – what makes it dangerous is that the virus is highly transmissible. Again, 80% of people who are infected can fight COVID-19, but in the other 20% there is an immune system response called the histamine complexes. Histamine is normal and everyone's body has it. However, involved in the histamine complex is something called Interleukin 6. When those IL6's get involved, a patient can go downhill very fast. The IL6's are actually trying to correct and balance the immune system's functions to respond to the COVID-19 virus. But because the virus replicates so quickly, the immune system goes into overdrive, which affects the organs. This is what causes people to die from COVID-19. And this is why we developed ENU200,” she said.
When asked about race and COVID-19, Harrison offered the following.
"COVID-19 is a pandemic, which means it is a virus that can kill anyone of any race, ethnicity or nationality. As a research company, we have a politically and racially agnostic culture. That allows us to stay balanced in our research and focus on the diverse make-up of people who are infected with COVID-19. Are there systemic issues related to race, COVID-19 infection and treatment? There very well could be. I think it's important to address these both systematically and on a case-by-case basis. Part of the disparities might be connected to hospitals being overwhelmed by the number of patients they're serving. That is something only a thorough investigation can get to the bottom of,” she explained.
Ennaid Therapeutics has designed a plan aimed at helping hospitals cope with the onslaught of COVID-19 patients. "Our plan includes launching 150 medical mobile units stocked with state-of-the-art equipment such as ventilators and oxygen tanks. The units will be staffed with one doctor, a physician's assistant and a nurse. We believe this support will help get COVID-19 under control and help patients of all ethnic backgrounds get life-saving care a lot sooner and more efficiently," she said.
The Center for Disease Control (CDC) confirmed a marked difference in the mortality rate of African Americans and Latinos infected with COVID-19. In a report released October 30, 2020, the CDC found that Blacks have an 18% greater chance than Whites of dying from COVID-19. The National Nurses United Organization released a report with data from nurses working in COVID-19 units across America. Their report confirmed a distinct difference in how Blacks and other people of color were treated for COVID-19 versus Whites. Factors include Whites being more likely to receive medication and early treatment for COVID-19 related illnesses such as pneumonia.
White COVID-19 patients were also more likely to be hospitalized at the onset of serious symptoms such as shortness of breath. Blacks and Latinos were often sent home. Some believe the lack of early treatment for Blacks and Latino COVID-19 patients is a critical determinant of mortality. The prevalence of pre-existing conditions among Blacks and Latinos with COVID-19 was also found to be a factor in the increased death rate.
In May 2020, after extensive scientific research, Harrison filed a patent for the ENU200 drug. She and her team made a groundbreaking discovery after testing a previously developed anti-viral drug that showed strong scientific evidence of blocking the two proteins that cause COVID-19. Ennaid's research showed that ENU200 could stop the virus COVID-19 from invading healthy cells and replicating.
"Drug discovery and development is quite the process. The first step is confirming that you have found what is called a ‘new chemical entity,’ i.e. a discovery backed by concrete data showing that a medication can target a particular disease. Next, you have to do what is called ‘proof of concept testing.’ Again, you're looking to provide data that shows the drug has positive results. You then proceed to animal testing under very safe and humane conditions. You look for a response that most closely mimics the disease in humans and the drug's effectiveness on it. You want to make sure there is no harm to the major organs in the animal. Once that's complete, you start a human clinical trial, which requires four levels of testing. There is a focus on efficacy i.e. the effectiveness of the drug and its safety to humans. Then you fill out an application for what is called an investigational new drug. The FDA takes all your findings into consideration as you go through the process for final approval,” she explained.
The ENU200 drug is what is called a repurposed drug, which means it is currently or once was on the market for a different indication or health issue. This means it already has human safety and discovery data and proof of concept, which confirms what Ennaid found in their discovery process.
"With a repurposed drug, almost 100% of the time a developer can skip the animal studies because we don't have to prove safety. This allows a developer to go into what is called a Phase 2B/3 clinical trial. This phase is to ensure safety for human subjects and that the drug is effective. That's the stage we're on with ENU200. We're actually and literally ready to put labels on our clinical materials and ship them to our clinical manufacturing site for our home, self-dosing clinical trials. You [TaShia] spoke earlier about the 80% of patients who have mild or moderate symptoms being sent home – those people would be ideal for our in-home clinical trials," Harrison said.
She continued, "The patient would just need to quarantine at home while they're taking the drug and participate in an app-based study of the results. We also developed a very simple app to track the improvement of patients. We anticipate the quarantine period being much shorter than the current 14 days. This is the final confirmation process for ENU200."
On December 15, CNN released a chilling report that every 60 seconds an American citizen dies of COVID-19. To date, over 300,000 Americans have died of COVID-19 and related complications. 16 million people are reportedly infected with the COVID-19 virus in the United States. In such dire circumstances, emergency use authorization from the FDA could fast track ENU200 and start saving lives.
"With the right financial backing, supported by the FDA or another regulatory agency, we could have the ENU200 product commercialized by or before summer 2021. We can also have mobile medical units ready as early as February 2021, or even during the winter. Because ENU200 comes in a pill or capsule form, it makes it simple to manufacture and ship across the world. It doesn't require any special storage or containment. Your doctor writes you a prescription for ENU200 at the onset of COVID-19 related symptoms. If our research findings hold up in the human trials, after a few days, we expect symptoms will start to ease. Then the body can do what it was built to do in helping people get well," she said.
Dr. Lane Rolling is a virologist and COVID-19 expert who recently published a book called Navigating a New World, which is a guide to staying safe and healthy during the pandemic. Rolling has what he feels are valid concerns about ENU200.
"I'm concerned about how the ENU200 drug will counter the RNA factor of the COVID-19 virus. COVID's mutation factor is what kills people. There are also at least 25 genetic mutations of the virus. COVID-19 is what is called an obligated intracellular parasite. In laymen's terms, that means the virus is inside of a cell. It has to get inside of your cells to live. How can you kill something inside of a cell without killing the person? I'm talking molecular biology here," he said.
Until ENU200 is approved, Rolling encouraged people to protect their good health.
"I know it sounds simple but I've found that simple things make all the difference in preventing and treating COVID-19. Eat healthy. Take your vitamins if you're not disciplined with how you eat. Medical studies have found that vitamin D and C are extremely helpful in strengthening the immune system. Get regular exercise. Try to keep a positive mental attitude. Following CDC protocols that include wearing a face mask every time you go out. Using antiseptic hand soap and sanitizing shoes after a trip outdoors. It's also important to clean meat products thoroughly as the virus has been linked to certain meats. I salute the work of scientist, Darnisha Harrison, and her company, Ennaid. I would be honored to support her research in any way I can. It's important for scientists and doctors to work together to find solutions."
Concerning the dangers and benefits of the COVID-19 vaccine, Rolling said, "There is a learning curve with any vaccine in terms of efficacy. I am a proponent and supporter of vaccines. However, it's important that we do watch and see in particular the effects of the vaccine on people with underlying conditions. We need a vaccine that is effective for all people, not just some."
In what has become a viral video circulating on social media, Chief Amaru Namaa Taga Xi-Ali Muhammad, the founder and president of the Aboriginal Medical Association, encouraged the public to utilize holistic strategies to combat COVID-19. He did not respond to inquiries from Denver Urban Spectrum on his opinion on the ENU200 drug but in his video on the COVID-19 vaccine, Muhammad too promotes simple solutions such as taking Vitamin D and spending at least 30 minutes daily in direct sunlight. He also encourages people to utilize supplements such as B5 i.e. Coenzyme A and talks about the benefits of a supplement called Acetylcholine, which he says is a "neurotransmitter that strengthens nerve cells impacted by COVID-19."
While subtly endorsing Trump during the 2020 presidential election, Muhammad is known for his radically pro-Black, openly anti-vaccine and anti-Western medicine beliefs. He claims his concerns about the harmful effects of the COVID-19 vaccine are rooted in scientific research. In his December 9, 2020 viral video, he said he believes the COVID-19 vaccine will harm Blacks and other people of color specifically. He, like Dr. Rolling, connects that harm to the prevalence of underlying conditions such as high blood pressure and diabetes among Blacks. He also cites the effects that quarantining and wearing masks for the last 12 months have had on people's immune system.
"What will help is eating foods like cantaloupe, avocados, grapes, dates, prunes, lemons, and oranges that are high in the nutrients listed earlier. Ingesting oils such as avocado, grapeseed and olive and eating olives are very good. Meats such as wild salmon, cod and bison if you're a meat eater will make a big difference," Muhammad said in his video.
Editor’s note: TaShia Asanti is an editor at large writing on issues related to social justice, disparities in healthcare and cultural diversity. More about her work can be found at www.officialtashiaasanti.com
Editor's note: Neither the article writer nor Denver Urban Spectrum are qualified to give medical advice. Consult your physician or wellness provider before following any health regimen.
- CDC Report on Ethnic Mortality Rates for COVID19: https://www.cdc.gov/mmwr/volumes/69/wr/mm6942e1.htm
- New England Journal of Medicine Article on Structural Racism in Public Healthcare: https://www.nejm.org/doi/full/10.1056/NEJMp2023616
- Report from the National Nurses United: https://www.nationalnursesunited.org/press/nurses-call-more-data-action-address-racial-disparities-during-covid-19-crisis
- Aboriginal Medical Association: https://www.youtube.com/watch?v=U3i3BnXPHs4