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LZ901, A Recombinant Herpes Zoster Vaccine And The Core Product Of Luzhu Biotechnology, Completed Phase II Clinical Trail In Q2 2023
World's First Herpes Zoster Vaccine With A Tetrameric Molecular Structure
BEIJING, May 30, 2023 /PRNewswire/ -- Beijing Luzhu Biotechnology Co., Ltd. ("Luzhu Biotechnology" or the "Company", together with its subsidiaries, the "Group", stock code: 02480.HK), a leading vaccine and antibody drug developer in China, is pleased to announce that the recombinant herpes zoster vaccine, a core product independently developed by the Group -- LZ901, its phase II clinical trial in China has been completed successfully in May 2023. The Company is in the course of advancing the multi-center, randomized, double-blinded, and placebo-controlled phase III clinical trial of LZ901 in the PRC, and targets to commence the same as early as possible.
The phase II clinical trial of LZ901 was designed as a randomized, double-blinded and placebo-controlled clinical trial. The primary objectives of this clinical trial are to evaluate the immunogenicity and safety of different doses of LZ901 in healthy people aged between 50 to 70 years old. The secondary objective of this clinical trial is to evaluate the immune persistence of different doses of LZ901 in healthy people aged between 50 to 70 years old. A total of 450 subjects aged between 50 to 70 years old were enrolled in the phase II clinical trial of LZ901.
Highlights of the phase II clinical trial results in the PRC are set out below:
LZ901 is a recombinant herpes zoster vaccine that induces a cellular immune response to confer strong protection against shingles. Unlike live attenuated virus vaccines, recombinant protein vaccine induces an immune response while avoiding risks of residual virulence from vaccinating with live attenuated herpes zoster virus. LZ901 is expected to be priced at a competitive retail price, with a total of two injections per treatment and does not require a third booster shot, which will be more affordable compared to the retail price of the other commercially available herpes zoster vaccines in China. In addition, as demonstrated in Phase I and Phase II clinical trials for LZ901 in China, the side effects from the administration of LZ901 are minimal as its liquid formulation only contains an aluminum hydroxide adjuvant and is free of immune stimulants, which demonstrated a favorable safety profile.
In addition, Luzhu Biotechnology has received IND approval from the United States Food and Drug Administration ("FDA") in July 2022 for LZ901 and initiated a Phase I clinical trial in the U.S. In February 2023. LZ901 is the only domestic vaccine in China that has conducted clinical trials in both the U.S. And China.
Shingles is becoming more prevalent in China due to a growing aging population that is more susceptible to shingles. As part of the continuous efforts of the central government to improve the health of the elderly, the National Health Commission recommends people aged 50 years and older to obtain herpes zoster vaccination to prevent shingles. This, coupled with comparable clinical trial data of LZ901 compared to the imported Shingrix, competitive retail price, high stability of the formulation, ease of storage and transportation, and convenience of use, provide LZ901 with strong market potential and competitive advantages.
Mr. Kong Jian, Chairman, Executive Director, General Manager and Chief Scientist of Luzhu Biotechnology, said, "Since our inception, we have strategically focused on internally developing innovative human vaccines and therapeutic biologics, including vaccines, monoclonal antibodies and bispecific antibodies targeting a broad spectrum of infectious diseases, cancer, and autoimmune diseases. Leveraging our technology platforms and strong research and development capabilities, we established a diversified and advanced product pipeline. LZ901 is the only domestic vaccine in China that has conducted clinical trials in both the U.S. And China, which demonstrates our outstanding R&D and product development capabilities. LZ901 is expected to be the first product of the Company to be commercialized. In the future, we will continue to actively promote the clinical development of our pipeline candidates, lay out strategic plans to promote commercialization at home and abroad, expand production capacity to meet growing market demand to provide the public with more high-quality and affordable vaccines and therapeutic biologics."
About Beijing Luzhu Biotechnology Co., Ltd.Luzhu Biotechnology is a biotechnology company committed to developing innovative human vaccines and therapeutic biologics to prevent and control infectious diseases and treat cancer and autoimmune diseases. Since its inception in 2001, the Group has focused on human medicine and established a technology platform with its understanding of immunology and protein engineering to empower the Group to develop recombinant vaccine and antibody product candidates with favorable efficiency, high purity and improved stability. The product pipeline of the Company consisted of three clinical-stage product candidates, including its core product, LZ901, and four pre-clinical-stage product candidates. On 8 May 2023, Luzhu Biotechnology was listed on the Main Board of The Stock Exchange of Hong Kong Limited (stock code: 02480.HK).
For more information about Luzhu Biotechnology, please visit http://www.Luzhubiotech.Com/
What Is The Virus That Attacked Sen. Dianne Feinstein And Justin Bieber?
What does Ramsay Hunt Syndrome do to a person?
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The office of Sen. Dianne Feinstein, the 89-year-old California Democrat who was diagnosed with shingles in February, confirmed Thursday she "continues to have complications" from a viral infection called Ramsay Hunt syndrome. The syndrome is caused by the same virus, varicella-zoster, that causes chickenpox and shingles.
In June, 2022, pop star Justin Bieber announced his face was partially paralyzed by the same virus. He told fans in a YouTube video the virus had attacked "the nerve in my ear, facial nerves and has caused my face to have paralysis. You can see this eye is not blinking. I can't smile on this side of my face. This nostril will not move."
Ramsay Hunt syndrome is a rare neurological disorder that occurs when the varicella-zoster virus infects a nerve in the head near the inner ear. After having chickenpox as a child or shingles as an adult, the virus can lay dormant in the body. Why the virus reactivates and produces symptoms of Ramsay Hunt is not known.
He told his fans that same month that — after doing facial exercises to battle the paralysis — he was slowly recovering, saying, "Each day has gotten better." And in March of this year, he shared a video of his face with a caption "Wait for it," then flashed a huge smile.
The syndrome, which is not contagious, affects about 5 out of every 100,000 people yearly in the United States, although some medical professionals believe many cases are undiagnosed.
"This makes its true frequency more difficult to determine," the Cleveland Clinic noted.
Symptoms can include a painful rash inside the ear canal and outside the ear, at times attacking the tongue and roof of the mouth, according to the Icahn School of Medicine at Mount Sinai. Due to the inner ear involvement, people with the condition can also suffer vertigo (the sensation of dizziness or things spinning around you), or tinnitus, a ringing in the ear.
Ramsay Hunt syndrome can also cause hearing loss on the side of the face affected. As in Bieber's case, it can also cause a weakness, facial droop or paralysis on the side of the face affected by the virus.
That weakness can cause difficulty with closing one eye, making facial expressions and eating, as food can fall out of the side of the weakened mouth.
Treatment consists of steroids such as prednisone to reduce inflammation and pain medication. At times, antiviral medicines that help with the herpes family, such as acyclovir or valacyclovir may be prescribed.
About 70% of people with Ramsay Hunt will regain complete or "almost complete" function of facial muscles, according to the Cleveland Clinic. Recovery time depends on the severity of the paralysis, and can take up to a year.
"Chances of a full recovery are better if you start treatment within three days of symptoms appearing. Early diagnosis and prompt treatment with antiviral therapy seem to improve long-term outcomes," the Cleveland Clinic notes on its website.
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Risk Of Shingles Complications By Age
Key Takeaways
A rash can be a sign of a few different things, from an allergic reaction to eczema. But when a rash is accompanied by other symptoms like itching, burning, pain, or vision problems, it could be a sign of shingles.
The symptoms and complications that come with a shingles diagnosis can vary depending on your age. Take Dianne Feinstein, a Democratic senator from California, as an example.
Feinstein, 89, was diagnosed with shingles in February but continues to have complications from the viral infection. These include encephalitis, a type of brain inflammation, as well as Ramsay Hunt syndrome (RHS), a rare neurological disorder that causes facial paralysis and rash.
Related: Signs and Symptoms of Shingles Rash
You may have heard of the latter thanks to another public figure. In June 2022, pop singer Justin Bieber was diagnosed with Ramsay Hunt syndrome, but did not report having any other serious complications associated with the condition. Ramsay Hunt Syndrome is caused by varicella zoster, the same virus that causes shingles and chickenpox.
Experts say even though both Feinstein and Bieber have RHS, they are having different experiences in terms of severity due to their age and immune system strength, along with whether or not they received the chickenpox vaccine as children.
How Different Age Groups May Experience ShinglesAnyone who has recovered from chickenpox can get shingles, including children and young adults. Still, the risk of developing shingles increases as you age, Anthony Szema, MD, a clinical immunologist at Three Village Allergy & Asthma and adjunct professor of technology and society at Stony Brook University, told Verywell.
People who have shingles can experience additional complications such as postherpetic neuralgia (PHN), which refers to burning pain in the nerves and skin. They're also at risk for eye complications, pneumonia, hearing problems, brain inflammation, and even death.
These complications increase as you get older and may be longer lasting compared to complications in a young person with shingles, Szema said. For example, an older adult with shingles is more likely to develop PHN and experience more severe pain.
Here is how the risk of shingles and its complications change across age groups:
Older adults (50 and older): The risk of developing shingles and its complications increases with age, particularly after the age of 50. About half of all shingles cases occur in adults who are 60 years of age or older. The chance of getting shingles becomes much greater by age 70. Older adults are also more likely to experience longer-lasting rashes, severe pain, and PHN.
Middle-aged adults (30 to 50): Adults between 30 to 50 years old can still develop shingles, however, the risk is lower and rare compared to older adults. Middle-aged adults can also experience complications associated with shingles, but they are generally less common in this age group.
Young adults (20 to 30 years): Shingles and its complications are relatively less common in younger people compared to older adults, Szema said. However, some individuals in this age group can develop the condition, particularly if they have specific risk factors like a weakened immune systems or underlying health conditions.
Related: What Causes Shingles?
Why Does Shingles Impact People So Differently?The main reason some people have a higher risk of getting shingles and experience more complications than others is because of age-related weakening of their immune systems, Szema said.
However, certain health conditions or treatments that weaken the immune system can also increase the risk of shingles and complications across all age groups.
"The older you are and the more immunocompromised you are, there are higher risks," Szema said. "If you have cancer or you're taking steroids, have leukemia, lymphoma, or if you have an organ transplantation, those things will also increase your risk."
Another reason why shingles tends to impact certain age groups differently, especially older adults, is because of a prior chickenpox infection, Michele Green, MD, a board-certified dermatologist at Lenox Hill Hospital in New York, told Verywell.
When someone gets chickenpox, they become more susceptible to developing shingles later in life because both shingles and chickenpox are caused by the same virus, known as the varicella zoster virus (VZV). While the virus remains inactive in nerve cells after the initial infection (chickenpox), it can reactivate again in adulthood, however, it develops into shingles rather than chickenpox.
"When you get the virus, it's inactive or dormant; it never goes away," Szema said. "We don't give anything to kill it, so at some point, it may become reactivated when your immune system is low."
If you get a chickenpox vaccine, you likely won't contract VZV, and your shingles risk—and therefore your shingles complication risk—is lower.
"Dianne Feinstein is of the age where she likely had chickenpox infection as a child, as opposed to most kids nowadays who get vaccinated at a very early age, and are never going to get chickenpox," Szema said. "Justin Bieber is of the age such that he was eligible for the chickenpox vaccine."
How Is Shingles TreatedAccording to Szema, treating shingles can involve a combination of antiviral medications, pain management strategies, and self-care measures.
Antiviral medications: Antiviral medicines like acyclovir, valacyclovir, and famciclovir can treat shingles, shorten the length and severity of the illness, and minimize a patient's chances of developing complications, Szema said. These medicines are most effective if you start taking them as soon as possible after the rash appears.
Pain management: Over-the-counter medications like Tylenol (acetaminophen) or Advil (ibuprofen) can help alleviate discomfort and in some cases, prescription medications can be used to manage severe pain. In addition, some topical creams or ointments can be applied directly to the affected areas.
Self-care measures: Itchy and painful skin and benefit from cool or damp compresses, calming lotions like calamine, or oatmeal baths. It's also important to cleaning the infected area and to avoid scratching as much as possible to prevent secondary infections. Green added managing stress and getting plenty of rest can also help promote healing and support the body's immune system in recovery.
It's important to note while these measures can help manage shingles, patients should still consult with their healthcare provider for a proper diagnosis and individualized treatment plan, Szema said.
Is It Possible to Prevent Shingles Complications?The most effective way to prevent shingles is to get vaccinated with the recombinant zoster vaccine called Shingrix, Szema said. It can also help prevent postherpetic neuralgia.
The Centers for Disease Control and Prevention (CDC) recommends two doses of the vaccine to prevent shingles and other related complications in adults 50 years and older. The vaccine is also recommended for those 19 years and older who have weakened immune systems due to disease or therapy.
The efficacy of two doses of the Shingrix vaccine for the prevention of shingles was high among all age groups, the CDC reports. In a clinical trial of more than 30,000 participants, the vaccine was 96.6% effective in adults 50 to 59 years, 97.4% effective in those aged 60 to 69, and 91.3% effective in adults aged 70 years and older.
Related: How Long Does the Shingles Vaccine Last?
Two doses of the vaccine were also found to be effective in the prevention of PHN. It was 91.2% effective in those 50 years and older and 88.8% effective in adults 70 years and older.
Besides vaccination, Green said people can prevent shingles by maintaining a healthy immune system. This means eating a balanced diet rich in fruits, vegetables, whole grains, and proteins, getting regular exercise and sleep, managing stress, and avoiding unhealthy habits like excessive alcohol consumption and smoking.
What This Means For You
The risk of developing shingles and any complications associated with the condition increases as you get older. Experts say one of the most effective ways to prevent shingles is to get vaccinated. If you have any questions about the risk of shingles, treatment, or prevention consult with your healthcare provider.
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