Researchers say new hope could be on the horizon for ALS patients in the form of a “groundbreaking” drug.
Nuvivo, a California biopharmaceutical company developing treatments for neurodegenerative diseases, is seeking approval for a new drug for amyotrophic lateral sclerosis (ALS).
According to the ALS Association, ALS is a progressive neurodegenerative disease that gradually impairs muscle function, eventually robbing patients of their ability to walk, talk, eat, and even breathe.
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This month, Neuvivo filed a new drug application (NDA) for NP001 (sodium chlorite infusion) with the U.S. Food and Drug Administration (FDA).
Researchers say new hope could be on the horizon for ALS patients in the form of a “groundbreaking” drug. (St. Petersburg)
The drug has received Orphan Drug and Fast Track designation from the FDA, making it eligible for accelerated approval and priority review, which could speed up time to approval, according to a press release.
“If approved, NP001 would be the first immunotherapy for ALS and the first ALS treatment proven to preserve lung function,” Matthew W. Davis, M.D., Nuvivo's chief medical officer, said on FOX News. told Digital.
urgent need
The company noted that there are currently no FDA-approved treatments for ALS that preserve respiratory function or extend lifespan beyond a few months.
The main cause of death in ALS patients is loss of lung function (respiratory failure).
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Approximately 30,000 adults in the United States currently have ALS, and 1 in 300 will be diagnosed with ALS during their lifetime.
The average life expectancy after a patient is diagnosed with ALS is 18 months.
Existing drugs fight ALS through the nervous system, but NP001 may be the first treatment that works by controlling inflammation in the immune system. (St. Petersburg)
“Unfortunately, half of the people living with ALS today are likely not to survive within three years,” Davis said.
Dr. Ernest Lee Murray Board certified neurologist Researchers at Jackson-Madison County General Hospital in Jackson, Tennessee, confirmed that the effectiveness of current ALS treatments is “very limited.”
different kind of medicine
Existing drugs fight ALS through the nervous system, but if approved, NP001 would be the first treatment that works by controlling inflammation in the immune system.
“While NP001 may be indicated for all ALS patients, our data support that patients with inflammation are likely to benefit much more,” Davis said.
“Unfortunately, half of the people currently living with ALS are likely not to survive within three years.”
Murray, who is not affiliated with Neuvivo, noted that excessive inflammation is a known factor in the progression of muscle weakness in ALS.
Although the initial study of NP001 did not show “statistically significant” improvements, the neurologist noted that “a reanalysis of previous data focused on a specific subgroup of patients with particularly high inflammatory markers.” said.
According to the ALS Association, ALS is a progressive neurodegenerative disease that gradually impairs muscle function, eventually robbing patients of their ability to walk, talk, eat, and even breathe. (St. Petersburg)
“This data suggests that by targeting specific immune system cells called macrophages, NP001 can slow the progressive loss of muscle function, particularly with respect to patients' ability to breathe,” Murray said. He told FOX News Digital.
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“Stopping macrophage activation often affects other immune cells as well and is expected to alter the progression of ALS.”
During the first month of treatment, NP001 will be administered as a daily 30-minute infusion for 5 consecutive days. (St. Petersburg)
For the first month of treatment, NP001 will be infused for 30 minutes each day for five consecutive days, according to Davis.
Each month thereafter, administer the drug in the same manner for three consecutive days.
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Davis said NP001 was “generally well-tolerated” in clinical trials.
The most commonly reported side effects were pain, redness and swelling at the site where the drug was injected, which were “generally temporary and mild.”
“This data suggests that NP001 can slow the progressive loss of muscle function.”
Professor Murray reiterated that early studies have demonstrated that NP001 is safe and well-tolerated.
“I am cautiously optimistic that as NP001 moves through the FDA's clinical trial process, it will demonstrate real improvement in ALS patients and provide hope to patients and families battling this devastating disease.” “There is,” he said.
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Davis said Neuvivo will continue to post updated information for patients and caregivers on its website as the drug undergoes FDA review.
