Patients with stiff person syndrome are one step closer to having access to a new treatment.

Kyverna Therapeutics’ new drug, KYV-101, has been designated by the U.S. Food and Drug Administration (FDA) a Regenerative Medicine Advanced Therapy (RMAT), the company announced on Monday.

A drug is eligible for RMAT designation if it is “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition” and if “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition,” according to the FDA’s website.

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One of the benefits of RMAT is that Kyverna will be able to work closely with the FDA to help support accelerated development, review and approval, according to the company.

The FDA’s decision was based on positive results from clinical trials with patients, a company press release stated.

A rare neurological disorder, stiff person syndrome affects only one or two people for every million — including singer Celine Dion.

The disease can have a devastating impact, causing muscle rigidity, pain, spasms and loss of mobility.

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Kyverna Therapeutics, based in Emeryville, California, developed the new CAR-T cell therapy, KYV-101, with the goal of “resetting” the immune systems of patients with autoimmune diseases, according to the company.

“As a physician dedicated to optimizing diagnosis and treatments for patients with autoimmune neurological disorders, I am grateful to be able to witness and contribute to the advancement of treatments and patient outcomes in stiff person syndrome via collaborative research efforts with leading players in the field and the support of the FDA oversight,” Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus in Aurora, Colorado, told Fox News Digital via email.

Céline Dion shared her stiff person syndrome diagnosis with the world in Dec. 2022. (Edward Berthelot/GC Images/Getty Images)

Piquet was not involved in the development of KYV-101, but did take part in one of the medical advisory boards.

Peter Maag, PhD, CEO of Kyverna, also commented on the announcement.

“This RMAT designation means science agrees that fast-tracking this treatment could save lives.”

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“Kyverna is focused on supporting patients and their clinical unmet needs, building patient-centric clinical trials to allow access to the latest medical advances in the CAR-T space for autoimmune disease,” Maag told Fox News Digital in a written statement. 

“We are proud to be able to investigate the potential of safe and effective long-lasting treatment that can lead to meaningful, durable remission for patients suffering from autoimmune diseases like SPS.”

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Patients also reacted to the news with a sense of excitement.

“From the moment I learned what Kyverna’s treatment had done for the SPS patient in Germany, my dream was that it would get FDA-approved quickly so we could all benefit,” Carrie Robinette, 45, from San Diego, California, told Fox News Digital.

A drug is eligible for RMAT designation if it is “intended to treat, modify, reverse or cure a serious or life-threatening disease or condition” and if “preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition,” according to the FDA’s website. (REUTERS/Andrew Kelly/File photo)

Robinette, a Navy wife and mother, was diagnosed with stiff person syndrome in spring 2023.

“This RMAT designation means science agrees that fast-tracking this treatment could save lives,” she added. “I’m thrilled for the entire autoimmune disease community.”

During clinical trials, 50 patients with oncological and autoimmune conditions have been treated with KYV-101 in more than 15 locations in Europe and the U.S., according to the company.

Kyverna will now continue collecting data from the drug’s Phase 2 trials for stiff person syndrome, multiple sclerosis and myasthenia gravis.

Carrie Robinette, 45, from San Diego, California, at left, and Corwyn Wilkey, 44, who lives in Anchorage, Alaska, right, are both living with stiff person syndrome. (Carrie Robinette; Corwyn Wilkey)

Phase 1 and 2 trials are also underway for systemic sclerosis and lupus.

“We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system,” Maag said in the company’s release.

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Added Piquet, “Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease … I look forward to the data that will emerge from the KYSA-8 trial, as this trial could drastically change the treatment landscape for SPS.”

Fox News Digital reached out to the FDA for additional comment.

A rare health condition could be causing some people to eat while they’re sound asleep. 

Sleep-related eating disorder (SRED) is an abnormal behavior called parasomnia that occurs during sleep.

The condition causes a person to eat — and in some cases even prepare food — while asleep, according to experts.

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Kara Becker, a certified eating disorders specialist and national director of eating disorder programs for Newport Healthcare in California, told Fox News Digital that people who experience this sleepy snacking usually have no recollection of it the next morning.

A person can have more than one sleep-eating event per night — and it can happen even if the person isn’t hungry, Becker noted.

Certain medications can cause SRED, as can smoking cessation, alcohol and drug use, stress, narcolepsy and dieting, according to the expert.

Drug-induced SRED can also occur after taking sedative-hypnotic drugs to treat insomnia, Cleveland Clinic noted on its website.

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Symptoms of the disorder can include repeated episodes of “out-of-control” eating and drinking when asleep, eating strange combinations of foods, or loss of appetite in the morning, Becker said.

The expert also flagged the dangers that can come with cooking or eating during the night, such as fires, burns and cuts.

Symptoms of the disorder can include repeated episodes of “out-of-control” eating and drinking when asleep, eating strange combinations of foods, or loss of appetite in the morning.  (iStock)

Fox News Digital also spoke to clinical psychologist Kelly Baron, PhD, director of the behavioral sleep medicine lab at the University of Utah, about symptoms and dangers of non-REM parasomnia.

SRED can cause dental issues and can interfere with weight-loss goals, Baron noted.

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“In some cases, the person could cook and injure themselves or run into things,” she warned. 

“People can eat non-food items at times,” Baron said. “I wrote a case series with a colleague and one patient had eaten dog food in his sleep or a casserole with his hands, making a big mess.”

People with SRED could “fall or bump into things” or cut or burn themselves during an episode, an expert warned. (iStock)

Consuming large amounts of calories without mindfully eating is “not recommended for anyone and can be very disruptive to adequate nutrition consumption,” Becker added.

“Some may even consume hazardous substances at night without knowing, putting their health immediately at risk.”

So who is at risk?

SRED episodes are more likely to occur with lack of sleep, so conditions like snoring and obstructive sleep apnea can be risk factors, according to Cleveland Clinic’s website.

People are more likely to have SRED if they’re closely related to someone who sleepwalks, if they feel stressed out or sleep-deprived during the day, if they suffer from an eating disorder, or if they have anxiety or depression.

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“For other people, having another sleep disorder can trigger sleepwalking behavior, including night eating, so having a sleep evaluation is really important,” Baron advised.

Those suffering from this condition should be evaluated at a sleep center, an expert said. (iStock)

For some people, sleepwalking is an inherited risk that continues from childhood into adulthood, according to Baron.

Treatment options

There are several treatment options for SRED, including reducing and eliminating triggers and addressing other sleep disorders, Baron told Fox News Digital.

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People can also implement techniques to improve sleep behaviors and try taking medication, the expert said.

Becker also suggested implementing safety precautions at home, like installing locks on kitchen cabinets and refrigerators and removing dangerous obstacles.

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People with SRED should also get “plenty of regular sleep,” she encouraged, as the condition can heighten with sleep deprivation.

“It’s also recommended to participate in a sleep study so that your health care provider can better understand your nighttime activity,” she said.

SRED is most common in women under 20 years old, according to Cleveland Clinic. (iStock)

SRED is a condition separate from night eating syndrome (NES), which causes people to feel compelled to eat before bed or to wake up multiple times in the night to eat and then return to bed, Baron said.

SRED is most common in women under 20 years old, according to Cleveland Clinic, but it can occur in anyone. 

Between 1% and 5% of adults experience parasomnia.

Experts suggest seeking a health care provider if SRED episodes are suspected.