Dallas clinical trial testing new approach to ALS gives patients & doctors hope

A North Texas ALS advocate shares her journey as Dallas researchers test an experimental treatment designed to slow the disease.

When Sunny Brous was 25 years old, she noticed something strange.

The muscles in her hand seemed to twitch, and her hand felt weak.

She says the issue became an eye-opener during a co-ed softball game.

"I couldn't close a glove," she recalled.

What followed was an 18-month search for answers before doctors diagnosed her with amyotrophic lateral sclerosis, better known as ALS.

"I think I'm still processing it... 11 and a half years later," she said.

ALS is a progressive neurodegenerative disease that attacks the nerve cells controlling voluntary muscles.

As those nerve cells die, people gradually lose the ability to move, speak, swallow, and eventually breathe.

There is no cure, and while treatments can help slow progression in some patients, the disease remains fatal.

According to Dr. Daragh Heitzman, director of the ALS and Motor Neuron Disorder Clinic at Texas Neurology in Dallas, the average life expectancy after symptoms begin is about three to five years.

"When you tell somebody they've got ALS, they know they have a terminal illness," Heitzman said.

Now, Dallas is among the sites participating in a Phase 2 clinical trial testing an investigational treatment called COYA 302.

Unlike most previous ALS therapies, which have focused on protecting damaged nerve cells, COYA 302 targets the immune system.

Researchers believe chronic inflammation contributes to the progression of ALS.

The experimental therapy is designed to improve the function of regulatory T cells, immune cells that help control inflammation, while reducing harmful inflammatory activity that may damage motor neurons.

Researchers hope slowing that inflammatory process could also slow progression of the disease.

"This is new," Heitzman said. "This has never been done before."

He said after participating in nearly 100 ALS clinical trials throughout his career, this study stands out because it attacks the disease in an entirely different way.

"It's exciting. I've been waiting for this for about 10 years," he said.

The ALSTARS trial is enrolling approximately 120 adults with ALS at 20 to 25 sites across the United States and Canada, including Texas Neurology in Dallas.

Participants are randomly assigned to receive one of two dosing regimens of COYA 302 or a placebo for 24 weeks, followed by an extension phase for those who complete the initial study.

Because the treatment is experimental, researchers do not yet know whether it will slow the disease.

The purpose of the study is to evaluate both its safety and effectiveness.

Although Brous has become a powerful voice for the ALS community, she is not eligible for this particular study.

Most ALS clinical trials enroll people relatively early in the course of their disease.

Having lived with ALS for more than 11 years, she falls outside the eligibility window for many studies.

Still, she says every new clinical trial represents hope for future patients.

Living with ALS has meant adapting nearly every aspect of daily life.

"It doesn't make sense unless you're right beside me all day exactly how much help I need in every part of my day," she said.

Despite those challenges, Brous refuses to let the disease define her.

"I use different aids and tools and things that help me," she said. "But I'm still me."

Through speaking engagements, advocacy and her nonprofit work, she hopes to raise awareness, support families affected by ALS and encourage continued investment in research.

"You don't have to live an ordinary life," she said through her message of Sunny Strong.

People interested in learning more about the ALSTARS clinical trial or whether they may qualify can visit trials.coyatherapeutics.com.

To learn more about Sunny Brous and her advocacy work, visit SunnyStrong.com.