Will We Soon Have a Cholesterol Vaccine?

I once had a conversation with a doctor who opined that statins should be put in drinking water to fight high cholesterol, similar to the way fluoride is added to municipal water sources in many cities to prevent tooth decay.

I’ve been taking statins for more than 14 years. Finding the right pill was torturous because of the side effects I experienced. The first statin I was prescribed made me feel like someone was punching me in the kidneys. It took several weeks after I stopped taking the statin for the pain to go away. When I was given a second option, the pain in my lower back was more manageable but it wasn’t until a pharmacist suggested I take a CoQ10 supplement along with the statin, that I finally found relief. My cholesterol levels have been under control now for a long time.

My wife recently was prescribed a statin for high cholesterol. Her side effects have been more alarming and she has had the prescription changed and twice has gone off the daily pill taking.

My brother-in-law uses an alternative injectable medication to control his cholesterol levels. He couldn’t tolerate statins either.

So much for putting the stuff in drinking water.

Combatting high cholesterol, however, is vital because as a chronic condition, it can double your risk of having a heart attack or stroke.

A Promising Vaccine Could Replace Statins

Recently, I read about an American company working on a vaccine to treat high cholesterol. The company is Vaxxinity, Inc., and so far, in non-human primate studies, their product, VXX-401, is demonstrating good results in treating hypercholesterolemia (high cholesterol) and preventing atherosclerotic cardiovascular disease. The study results have recently been published in The Journal of Lipid Research. The company is now in Phase 1 clinical trials.

VXX-401 vaccine, when administered to cynomolgus monkeys, showed that it stimulated their immune systems to produce antibodies to target Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9), a natural protein associated with the production of cholesterol in the body. By blocking PCSK9, the vaccine lowered cholesterol levels in the blood.

Facts About Cholesterol

It is a waxy substance found in all cells in the body. It plays a significant role in the production of hormones, vitamin D, and bile acids. It comes in two forms: Low-Density Lipoprotein (LDL-C) and High-Density Lipoprotein (HDL).

The former, LDL-C, has been given the moniker “bad cholesterol” because when there is too much of it, it can build up on arterial walls where it can block blood flow and compromise the heart. Both cholesterols are produced in the liver and small intestine.

HDL, the “good cholesterol” controls LDL-C levels in the blood helping the body to get rid of too much.

High LDL-C levels can have a genetic component, but most often lifestyle, diet, and weight are the cause.

Vaccine Results So Far

VXX-401, so far, has demonstrated it reduces LDL-C levels on average by 44% in animal studies. It also appears to be well tolerated. Across three separate preclinical studies in cynomolgus monkeys, VXX-401 induced a strong and durable antibody response against PCSK9 and robust, sustained reduction of LDL-C over time. Prolonged exposure with VXX-401 resulted in an average of 44% LDL reduction. VXX-401 was well tolerated and did not induce any toxicity or pathology beyond mild injection site reactions. These results suggest that VXX-401 could be a safe and effective anti-PCSK9 immunotherapy.

VXX-401 was designed using Vaxxinity’s proprietary synthetic peptide vaccine platform Mei Mei Hu, Vaxxinity’s CEO, in a press release announcing the publication of the latest non-human primate results stated, “Despite multiple approved medications for LDL-C reduction, heart disease remains the number one killer in the world. A cholesterol vaccine like VXX-401 may provide a cost-effective and widely deployable solution that could potentially benefit hundreds of millions of people at risk. A well-tolerated intervention that people can start early in life, and remain on for many years, lowering the cholesterol ‘area under the curve,’ has the potential to help us win the fight against heart disease.”

Phase 1 of the clinical trial of VXX-401 is focused on determining the safety of its administration and how well it is tolerated in humans. We should see preliminary results by late summer.

Vaxxinity isn’t just looking at treating hypercholesterolemia. The company’s mission is to democratize healthcare through the pioneering of a new class of medicines aimed at disrupting existing treatments for several chronic diseases while reducing the cost to patients. The company is using its novel synthetic peptide immunotherapy vaccine candidates to treat Alzheimer’s, Parkinson’s, migraine, and COVID-19.