New hope could be on the horizon for ALS patients in the form of a “breakthrough” drug, researchers say.

Neuvivo, a California biopharmaceutical company that develops therapies for neurodegenerative diseases, is seeking approval for a new medication for ALS (amyotrophic lateral sclerosis).

ALS is a progressive neurodegenerative disease that gradually impairs muscle function, eventually robbing the patient of the ability to walk, talk, eat and even breathe, per the ALS Association.

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This month, Neuvivo submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for NP001 (sodium chlorite infusion).

The drug has been granted orphan drug and fast track designations by the FDA and is eligible for Accelerated Approval and Priority Review, which could shorten the time to a potential approval, according to a press release.

“If approved, NP001 would be the first immunotherapy for ALS, and the first ALS treatment shown to preserve lung function,” Matthew W. Davis, MD, chief medical officer of Neuvivo, told Fox News Digital.

An urgent need

There are currently no FDA-approved treatments for ALS that preserve breathing function or extend life by more than two or three months, the company noted.

The leading cause of death in patients with ALS is loss of lung function (respiratory failure).

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Approximately 30,000 adults in the U.S. are currently living with ALS, and one in 300 people will be diagnosed in their lifetime.

The average life expectancy after a patient is diagnosed with ALS is 18 months.

While existing drugs combat ALS through the nervous system, NP001 would be the first therapy that works by controlling inflammation in the immune system. (iStock)

“Half of the people living with ALS today will unfortunately not likely be living in three years,” Davis said.

Dr. Earnest Lee Murray, a board-certified neurologist at Jackson-Madison County General Hospital in Jackson, Tennessee, confirmed that current ALS treatments are “very limited” in their effectiveness. 

A different kind of drug

While existing drugs combat ALS through the nervous system, NP001 — if approved — would be the first therapy that works by controlling inflammation in the immune system.

“NP001 would be indicated for all patients with ALS, although our data supports that patients with inflammation are likely to have significantly greater benefit,” Davis said.

“Half of the people living with ALS today will unfortunately not likely be living in three years.”

Murray, who is not affiliated with Neuvivo, noted that excessive inflammation has been a known factor in the progression of muscle weakness in ALS. 

While initial studies of NP001 did not show any “statistically significant” improvement, the neurologist said, “reanalysis of the previous data looked at certain subgroups of patients with particularly high inflammatory markers.”

ALS is a progressive neurodegenerative disease that gradually impairs muscle function, eventually robbing the patient of the ability to walk, talk, eat and even breathe, per the ALS Association. (iStock)

“This data suggests that NP001 can slow progressive loss of muscle function, especially when it comes to a patient’s ability to breathe, by targeting a specific immune system cell called a macrophage,” Murray told Fox News Digital.

“Halting the activation of macrophages oftentimes can have an effect on other immune cells, which will hopefully alter the progression of ALS.”

During the first month of treatment, NP001 is given as a 30-minute infusion each day for five consecutive days. (iStock)

During the first month of treatment, NP001 is given as a 30-minute infusion each day for five consecutive days, according to Davis.

Every month thereafter, the medication is given for three consecutive days in the same way.

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NP001 was “generally well-tolerated” in clinical trials, Davis said.

The most commonly reported side effect was pain, redness and swelling where the drug was infused, which were “generally transitory and mild.”

“This data suggests that NP001 can slow progressive loss of muscle function.”

Murray echoed that early studies have demonstrated that NP001 is safe and well-tolerated. 

“I am cautiously optimistic that as NP001 moves though the FDA process of clinical trials, it will show true improvement in ALS patients and offer some hope to patients and families dealing with this devastating disease,” he said.

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As the drug undergoes FDA review, Neuvivo will continue to post updates for patients and caregivers on its website, according to Davis.

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Sixty-two percent of adults in the United States say they drink alcohol, according to a July 2023 Gallup survey. This widely outnumbers those who say they completely abstain — which came out to 38% of Americans. 

Many month-long challenges have been advertised as a way to persuade people to spend 30 days without alcohol. “Dry January” and “Sober October” are examples of alcohol-free challenges that are popular to pursue. 

January and October are by no means the only times when alcohol use can be halted. A 30-day (or more) challenge is a great way to help your overall health and wellness, as there are several benefits that could come out of abstaining from alcohol for a period of time. 

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Below are five health-related improvements you may see if you spend 30 days alcohol-free. 

1. A better night’s sleep
2. Improved liver health
3. Weight loss
4. Improvements to brain function
5. Better digestion

1. A better night’s sleep

Better sleep can result from a lack of alcohol consumption — and better sleep leads to improved overall health. 

Research has shown that when alcohol is consumed close to the time you go to bed for the night, quality sleep can be interrupted, according to Healthline. 

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This loss of quality sleep will give you a groggy feeling the next day. 

Once alcohol is removed from your routine, your sleep cycle can start to get back on track, leaving you more alert and refreshed in the morning. 

By abstaining from alcohol for 30 days, you could very well see improvements to your sleep.  (iStock)

2. Improved liver health

Drinking alcohol can increase the risk of many different diseases. One of these is liver disease. 

There are three main types of alcohol-associated liver diseases that exist, according to Johns Hopkins Medicine. These are steatotic (fatty) liver, acute hepatitis and cirrhosis, according to the source. 

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Steatotic liver is the most common, according to the source, and “is the build-up of fat inside the liver cells.”

Acute hepatitis “is an acute inflammation of the liver cells,” according to Johns Hopkins Medicine, while cirrhosis “is the destruction of normal liver tissue.” 

All of these diseases are caused by heavy alcohol consumption. The liver is what breaks down alcohol, so drinking too much can cause severe damage. 

Heavy alcohol consumption can be dangerous to the liver.  (iStock)

One of the most important steps in treating a liver disease is not drinking alcohol, according to Johns Hopkins Medicine. By avoiding alcohol, the liver can be healed of some damage that was caused, depending on the severity of the case, the source notes. 

3. Weight loss

Excessive drinking may lead to weight gain, so the opposite could hold true when cutting alcohol out of your system, according to Healthline.

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Alcohol is extremely high in calories (especially super sweet drinks). It lacks nutrients and could cause hormones signaling appetite, hunger and stress to go off in your body, according to Health.com.  

While light to moderate drinking is unlikely to cause weight gain, heavy drinking could. 

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) lays out drinking guidelines, defining heavy drinking as four or more drinks per day, or eight or more per week for females, and five or more drinks per day or 15 or more drinks per week for males.

Since alcohol can cause weight gain, taking it out of your life can have the opposite impact.  (iStock)

4. Improvements to brain function

Thirty days of being alcohol-free can improve brain function and your overall mood. 

“Alcohol makes it harder for the brain areas controlling balance, memory, speech, and judgment to do their jobs, resulting in a higher likelihood of injuries and other negative outcomes,” the NIAAA notes on its website. 

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Thera are also long-term affects on the brain from heavy drinking, such as “alterations in neurons.” 

Adolescent brains are even more susceptible to long-term damage from heavy alcohol consumption, according to the source. 

Consider giving your brain a break to help improve its function.

Alcohol consumption has short and long-term impacts on the brain.  (iStock)

5. Better digestion

Do you ever have an upset stomach after drinking? Experience acid reflux? You’re not alone.

After a night of drinking, a person can experience a hangover. While hangover symptoms can vary from person to person, some common symptoms include fatigue, weakness, thirst, headache, muscle aches, nausea, stomach pain, vertigo, sensitivity to light and sound, anxiety, irritability, sweating and increased blood pressure, according to the NIAAA. 

Gastrointestinal irritation caused by consuming alcohol can happen, as the lining of the stomach is a part of the body directly impacted by alcohol, per the source, increasing acid release, which can cause nausea and discomfort in an individual. 

Inflammation can also increase with alcohol consumption. That increased inflammation can cause hangover symptoms to be presented, according to the NIAAA. 

Therefore, a sober month gives your stomach a break and helps contribute to an overall healthy lifestyle.