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Welcome to today’s Biotech Spotlight, a series highlighting companies creating groundbreaking technologies and products. Today, we’re featuring Arialys Therapeutics, a biotechnology company developing autoimmune neuropsychiatric treatments.
focus: Peter Flynn, President and CEO of Arias Therapeutics
Company Vision: Arialys Therapeutics is a preclinical stage company developing treatments for a rare and potentially fatal autoimmune disease called Anti-NMDA Receptor Encephalitis (ANRE), which is often misdiagnosed due to its associated psychiatric symptoms. Arialys’ lead candidate, ART5803, inhibits the autoantibodies that cause the disease, rather than suppressing the entire immune system, which is the current standard of care.
ANRE rose to fame through her bestselling memoirs. Brain burningThe journalist said he suffered a “crazy month” with sudden seizures, hallucinations and other symptoms that led to him being misdiagnosed with everything from schizophrenia to alcohol withdrawal.
Arialis Therapeutics Launching in September The company purchased ART5803 from Astellas Pharma and plans to raise $58 million in seed funding in 2023. Additionally, Mitsuyuki Matsumoto, the lead developer of ART5803, joined Arialys as scientific founder and chief scientific officer after serving as head of neuroscience research at Astellas Pharma.
The drug works by competitively inhibiting the antibodies that cause ANRE.
“The actual product is elegant and simple,” Flynn says. Joined in June“We’re not actually affecting the patient’s immune system; we’re finding out what’s making them sick and blocking it with a different antibody.”
Why is this important: When people think of autoimmune diseases like rheumatoid arthritis, lupus and multiple sclerosis, they think of familiar symptoms like fatigue and joint pain. But less is known and understood about autoimmune diseases that target the brain, where certain autoantibodies can trigger psychosis, leading to a sudden “terrifying descent” into psychotic symptoms, Flynn said.
“The challenge with this disease is that we have patients who have no history of neuropsychiatric illness, and their symptoms rapidly worsen,” Flynn said. “And the sad thing is that some of these patients end up in psychiatric wards, even though they’re not traditional psychiatric patients, they’re autoimmune disease patients.”
There is also growing evidence to suggest that autoimmune diseases of the brain may be much more prevalent than currently known.
“Some patients diagnosed with schizophrenia and other mental illnesses may actually have an autoimmune component to their illness,” Flynn said. “Educational figures suggest that 5 to 10 percent of people with mental illness may have these autoantibodies.”
Challenge: ANRE is First identified In 2007, more and more autoimmune diseases and antibodies related to the brain were identified.
“this is Fairly new area “ANRE is beyond the bounds of science,” Flynn said. “Right now, about 2,000 patients in the United States have been diagnosed with ANRE, but as we’ve said, it may be chronically underdiagnosed.”
Due to underdiagnosis or misdiagnosis, these patients are often treated for psychiatric symptoms rather than the underlying autoimmune disease. So in addition to developing ART5803, Arialys is also developing a test that detects antibodies in cerebrospinal fluid and is more sensitive than current tests, Flynn said. Arialys is not currently developing the test as a companion diagnostic, but plans to use it to better understand the true prevalence of the disease.
“It’s unusual, but on a global scale we still think there’s a market,” Flynn said. “We’ll eventually see what percentage of the population this applies to.”
Another challenge: An estimated 45% of these patients are children, so they need a treatment that works quickly. Flynn said preclinical studies have shown that ART5803 works within days or weeks, not months.
“I think rapid, acute treatment is going to be really important in this field,” Flynn said. “The standard of care is immunosuppressants, and patients recover. But I think timing is everything. And when we think about pediatric patients in particular, we want them back on track as quickly as possible, because there could be long-term cognitive impacts.”
The Road Ahead: ART5803 has been granted orphan drug designation by the FDA and has been shown to inhibit NMDA receptor autoantibodies and ameliorate encephalitis and behavioral symptoms in preclinical non-human primate models.
Flynn said the company recently filed its first regulatory application and plans to begin clinical trials in healthy volunteers later this year.
He also called ART5803 a “pipeline within assets” because there are other indications where a “superior competitive inhibitor approach to autoimmune neuropsychiatric diseases” could be applied.
Ultimately, identifying cases and understanding the true prevalence of the disease will be key.
“I think it’s completely understood and accepted in academia that we’ve only just barely begun the journey of understanding how autoimmune diseases actually impact neuropsychiatric disorders,” Flynn said.
