SOT Treatment for Lyme Disease

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SOT for Lyme Image from Marty Ross MD

Updated: April 25, 2022

Probability of Health Improvement

  • My clinical experience: not enough experience to say
  • MyLymeData: no research conducted 
  • Other research: no published research
  • Placebo effect benefit of any prescription medicine: 30 to 40 percent

For more information about the best research-supported germ killing approaches to recover from Lyme disease see What Works? Navigating Prescription & Alternative Medicine Lyme Treatments.

Supportive Oligonucleotide Therapy (SOT) Background

Supportive Oligonucleotide Therapy (SOT) is a new treatment for Lyme disease. SOT is also called Antisense Oligonucleotide Therapy (ASOT) which is the term used in medical research papers. SOT uses laboratory derived nucleic acids (genetic code) that blocks production of disease causing proteins or even gene expression. These pieces of genetic code are called oligonucleotides. You can think of oligonucleotides as a genetic message.

For example, in Duchenne Muscular Dystrophy (DMD), SOT provides oligonucleotides that direct the correct production of a protein called dystrophin. People with muscular dystrophy are born with DNA that provides the wrong genetic message for dystrophin. SOT correction to the DNA message leads to production of dystrophin. This prevents the muscle damage seen in DMD.

In Lyme disease, a currently available type of SOT produced by RGCC in Greece uses oligonucleotides intended to stop germ growth and replication. Unlike the SOT therapy for Duchenne muscular dystrophy, the Lyme SOT is not a US Food and Drug Administration (FDA) approved drug. To be approved by the FDA, a therapy must have scientific evidence of safety and effectiveness. 

As I explain below, SOT does not alter DNA. It provides a short-term change to how the DNA blueprint is expressed.

There are currently nine SOT drugs approved by the FDA or European regulators to treat

  • Batten disease,
  • cytomegalovirus retinitis,
  • Duchenne muscular dystrophy,
  • familial chylomicronemia syndrome,
  • familial hypercholesterolemia,
  • hereditary transthyretin-mediated amyloidosis, and
  • spinal muscular atrophy.

According to Wikipedia there are nearly 50 SOT drugs in various levels of clinical trials. In my research, I am not able to identify one laboratory or human trial using SOT for Lyme disease.

Lyme Disease SOT Claims

In Lyme disease these oligonucleotides are being used to interrupt and block protein production required for the germ to replicate and grow. In theory, this leads to the death of existing germs and stops the spread of new germs.

The clinics currently offering SOT therapy in the United States are purchasing non-FDA approved SOT drugs from a Greek genetic laboratory called RGCC. According to RGCC, it is in the process of publishing a paper about SOT, but is not willing to share its data at this time. So I cannot evaluate any claims of SOT benefit from the RGCC products.

More About How SOT Works: A Genetic Primer

DNA, RNA, Oligonucleotides

Our genetic code that provides the blueprint for the production of proteins in the body is called DNA. The building blocks of DNA are called nucleic acids. There are five different kinds of nucleic acid: adenine, cytosine, guanine, thymine, and uracil. Thymine occurs only in DNA and uracil only in RNA. DNA is made of two strands of nucleic acids wound around each other.

The DNA message and directions for protein production are turned into RNA. RNA is a single strand of nucleic acids. DNA is found in the center of a cell. Once the RNA is made from the DNA, it moves to part of the cell where protein is made. The RNA’s directions are read in a protein production factory in the cell called a ribosome. If the RNA is readable, a specific protein coded by the RNA is made.

Oligonucleotides are short strands of nucleic acids. These strands are much shorter than RNA and DNA. Oligonucleotides are usually made of 15 to 20 nucleic acids.

How SOT Works

There are a variety of ways that SOT could work in Lyme disease. Below I discuss three of these ways. 

One way that SOT works is to provide oligonucleotides that bind to part of the RNA. This prevents the RNA from being read. These are blocking oligonucleotides that bind to a type of RNA called messenger RNA or mRNA for short.

Another way some SOT works is to bind to the mRNA and then cut it up into unreadable pieces.

There is also a type of microRNA called miRNA. This type of RNA regulates protein production or even germ replication. One type of SOT can bind the miRNA so it cannot work.

The RNA-SOT complex is eventually broken down in the cell by enzymes and replaced by new RNA. To be clear, SOT oligonucleotides do not change the DNA blueprint for the body or the DNA of germs.

Potential Problems with SOT

Correctly Identifying the Patient's Infections

As I understand, the SOT treatment by RGCC for each patient is individualized based on testing of the patient's blood for active infections. The testing technique is to use a PCR method to detect the DNA of the various bacteria. This is problematic though. PCR testing for Lyme infection is well known to only find Lyme 30 percent of the time when someone has the infection. In the case of Bartonella, the germ often does not live in the blood, so trying to detect DNA of Bartonella, is often not effective either. Given this issue - I question how RGCC is developing treatments for these two infections that often are not found with PCR testing.

Knowing of this issue, in an email to RGCC on April 18, 2022, I asked RGCC to provide validation studies for its PCR testing method. In a validation study, a lab tests its method on samples of blood that have and do not have the infection. They then find out if their test is effective at correctly determining which samples have the infection and which ones do not. RGCC responded that its test technique is certified and valid. However, it did not provide me any information about how the validation studies were performed or how effective they were at determining if someone has the infection(s) when present. In other words, even though they claim their tests are valid, I cannot tell if they really work for Lyme and the various coinfections.

Reaching the Inner Cell

Our bodies make enzymes that break down RNA and oligonucleotides. This presents a problem, because the oligonucelotide could be destroyed before they even bind to RNA. The pharmaceutical industry has developed various modifications to the sugar backbone of the oligonucleotides to make them resistant to the breakdown enzymes.

SOT oligonucleotides have to cross the cell membrane, moving from outside to inside the cell, where they bind to RNA. This presents another problem for SOT. There are different ways the pharmaceutical companies are addressing this problem. For instance, some SOT is wrapped in microscopic layers of fat to increase absorption into the cells.

Safety Issues

There are potential safety issues. Some SOT therapies investigated by the pharmaceutical industry are shown to accumulate in organs like the kidney, liver, and spleen causing injury and toxicity.

Reaching Every Germ and Every Germ Type

SOT for Lyme needs to target each type of infection that is part of the person’s Lyme disease. This presents two problems. First, an SOT therapy should target Lyme germs and other infections if present like Bartonella and Babesia. Second, regarding Lyme, the germ hides away

  • inside cells,
  • in tissues with poor blood flow like tendons and scar tissue, and
  • deep within biofilm communities.

So it is very doubtful one infusion of SOT will reach all germs where they hide.

Lyme and Bartonella germs can exist in non-growing persister forms. SOT is designed to block growth and replication. By definition, persisters are not growing - they are hibernating. So it is very unlikely SOT could kill persister forms. For more information about Lyme persisters and persister treatments see How to Treat Persister Lyme. What Works?

RGCC, SOT Clinics, and Regulation

I suspect the FDA will eventually shut down centers providing Lyme SOT that is not FDA approved. My interpretation of FDA regulation suggests SOT oligonucleotides qualify as a drug. Drugs are subject to FDA regulation - the FDA only allows for the sale and use of approved drugs. Lyme SOT provided by RGCC is not an FDA approved drug. For more information read the FDA guidance.

Does Lyme Disease SOT Work?

I am not sure if current SOT for Lyme disease or coinfections works. As I discuss above, there are a number of obstacles for effective Lyme SOT. Given the barriers of SOT reaching every Lyme germ and likely not having activity against persister Lyme, I am doubtful this is an effective therapy for most people. I have seen a small number of patients in my clinic who have tried this therapy before seeing me with minimal to no effect. Some of my physician colleagues who offer this therapy claim some patients have improvement.

The Benefits Could Be A Placebo Effect

Keep in mind that the average drug in clinical trials has a placebo effect of 30 to 40 percent. This means in clinical trials 30 to 40 percent of people improve by taking an inert pill without an active ingredient - a so- called sugar pill. So if some claim benefit from SOT, it may have nothing to do with the oligonucleotides of SOT - the benefits could be a placebo effect.

Collective Experience Matters

Many therapies physicians offer in Lyme disease have limited science or studies showing they work. So the fact that Lyme SOT does not currently have any studies supporting its use, does not stop me from considering its use. However, even though many Lyme therapies have limited science, collectively health care providers share knowledge based on our experiences about whether or not a therapy works. So when research is lacking, we can learn what may work for Lyme based on our collective shared experiences. For SOT, there currently is not enough collective experience among patients, physicians, or other health care providers showing if SOT is effective. 

The Future of SOT

SOT therapies hold great promise for a variety of illnesses. It is possible a pharmaceutical company will find a way to address each of the concerns about safety and delivery I raise above. If it is developed correctly, Lyme SOT could change the face of Lyme disease treatment and improve patient outcomes.

I look forward to seeing research in this area as it evolves. In particular, I look forward to seeing the paper that RGCC is writing about Lyme SOT. I hope they will address safety concerns and the effectiveness of their testing and treatments.

Disclaimer

The ideas and recommendations on this website and in this article are for informational purposes only. For more information about this, see the sitewide Terms & Conditions.

References

View Citations

  1. Brown WA. The Placebo Effect. Scientific American. 1998;278(1):90–95. (View
  2. Dhuri K, Bechtold C, Quijano E, et al. Antisense Oligonucleotides: An Emerging Area in Drug Discovery and Development. J Clin Med. 2020;9(6):2004. Published 2020 Jun 26. doi:10.3390/jcm9062004 (View)
  3. Enck P, Klosterhalfen S, Weimer K, Horing B, Zipfel S. The placebo response in clinical trials: more questions than answers. Philos Trans R Soc Lond B Biol Sci. 2011;366(1572):1889-1895. doi:10.1098/rstb.2010.0384 (View
  4. Classification of Products as Drugs and Devices and Additional Product Classification Issues: Guidance for Industry and FDA Staff. September 2017. (View) Accessed April 22, 2022.
  5. Harris et al. An Understanding of Laboratory Testing for Lyme Disease. Journal of Spirochetal and Tick­borne Diseases—Volume 5, Spring/Summer 1998.
  6. Wikipedia contributors. Antisense therapy. Wikipedia, The Free Encyclopedia. August 1, 2020, 14:27 UTC. Available at: https://en.wikipedia.org/w/index.php?title=Antisense_therapy&oldid=970637810. Accessed August 1, 2020

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About the Author

Marty Ross, MD is a passionate Lyme disease educator and clinical expert. He helps Lyme sufferers and their physicians see what really works based on his review of the science and extensive real-world experience. Dr. Ross is licensed to practice medicine in Washington State (License: MD00033296) where he has treated thousands of Lyme disease patients in his Seattle practice. 

Marty Ross, MD is a graduate of Indiana University School of Medicine and Georgetown University Family Medicine Residency. He is a member of the International Lyme and Associated Disease Society (ILADS) and The Institute for Functional Medicine.

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