There could be new hope for ALS management as a promising drug enters phase 3 clinical trials.

ALS is a progressive disease in which the brain loses connection with the muscles, The ALS Association states. This slowly strips away a person’s ability to walk, talk, eat, dress, write, speak, swallow and, eventually, breathe.

The “PREVAiLS” study, which will review the investigational drug pridopidine as a potential ALS treatment, has already enrolled its first participant, according to a press release from Prilenia Therapeutics and Ferrer, developers of the drug.

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The first participant has been enrolled at Mass General Brigham under the supervision of Sabrina Paganoni, MD, PhD, co-director of the Mass General Hospital Neurological Clinical Research Institute and lead researcher in the PREVAiLS trial.

“Pridopidine is a sigma-1 receptor (S1R) agonist,” Paganoni shared in a statement. “The S1R has been shown to play a role in stimulating multiple neuroprotective pathways impaired in neurodegenerative diseases, such as ALS and Huntington’s disease.”

The global clinical trial, which will include 500 participants, aims to evaluate the safety and effectiveness of pridopidine in slowing the progression of ALS in early, rapidly progressive patients. The trial is expected to take place in up to 60 ALS treatment centers across 13 countries.

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This is a follow-up to the phase 2 HEALEY ALS Platform Trial results in 2023, which did not reach its main goal of slowing ALS function over the 24-week study period. That research, however, did see positive results in a subgroup of patients who were early in disease and declining rapidly.

In the HEALEY trial, the drug was generally well-tolerated, with a safety profile similar to placebo. The most common adverse events were falls and muscle weakness, which overlap with ALS symptoms.

PREVAiLS is believed to be the only currently recruiting phase 3 ALS study, according to the release.

Phase 3 incorporates “key learnings” from phase 2, Paganoni shared with Fox News Digital, and is expected to determine whether pridopidine is effective as a potential treatment for the disease.

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“Enrolling the first participant in this confirmatory study is a milestone in our search for potential new therapeutic options that may help to slow disease progression, preserve function, maintain speech and prolong survival – key aims of early ALS therapy,” she said.

“As with all clinical research, definitive conclusions won’t be available until the phase 3 trial is completed and fully analyzed.”

Kuldip Dave, PhD, senior vice president of research for The ALS Association in New York City, also commented on the “urgent need” for new ALS treatment options.

“The earlier we can diagnose and treat ALS, the greater the potential to preserve function and maintain quality of life for longer, which is key to making ALS livable until we can cure it,” he said in the release.

“It was discouraging to see a lack of overall effect in the phase 2 study population,” he said. “However, we were encouraged to see positive signals emerge from various subgroups, including potential impacts on speech and respiratory function.” 

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“Because respiratory decline is a leading cause of ALS morbidity and mortality, even modest preservation of breathing capacity can have a meaningful impact on both quality of life and overall outcomes.”

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The insights gained from the phase 3 trial will be critical in determining whether these early signals translate into “meaningful, consistent benefits for people with early, rapidly progressing ALS,” Dave added.

Dave praised ALS patients for their participation in these studies, along with family members and caregivers for their support. ”Participating in ALS research is one of the most powerful ways individuals can contribute to accelerating scientific discovery and making ALS livable until we cure it.”

Early signs of the disease include muscle weakness, stiffness and cramping. Symptom progression and severity are different for each case, and the association notes that there is “no single timeline for ALS.”

The disease only affects motor neurons controlling voluntary movement, so the five senses — sight, touch, hearing, taste and smell — are not affected, nor are the eye muscles or bladder control.

Diagnosis typically occurs between the ages of 40 and 70. Many ALS patients remain “mentally alert and aware” throughout the disease, The ALS Association reported.

ALS is “always fatal,” Dave told Fox News Digital, as most people live only three to five years after diagnosis. About 20% of patients live five years or longer, and only about 5% live longer than 20 years.

There is currently no cure or treatment to stop disease progression.

Prilenia, a Netherlands-based biotech company, shared with Fox News Digital that as neurodegenerative diseases progress, the damage is “irreversible,” making them difficult to treat. 

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“This is why we are focusing on an early, rapidly progressive patient population rather than a broader range of patients, as this provides the best chance of evaluating drug effect within the confines of a time-limited clinical trial,” the company stated.

There’s a lot out there that can really be disturbing. A friend calls with some scary medical news; I start wondering about my own health. I check the stock market and become obsessed about money — will we ever have enough for retirement? I read a news story and see only suffering in the world. My whole sense of well-being gets out of whack.

What I need to remind myself — what is right there in the celebration of Easter — “Give it some time. Give it three days.” Change is happening. Good things can come after complete horror. Give it three days.

Let me circle back to an old story, surely apocryphal, but sweet and helpful.

A woman goes to church on Easter Monday and as she leaves, she pauses to chat with a disheveled woman sitting on the steps selling corsages and boutonnieres — a meager means of making a living. And yet, despite her appearance, the old lady is full of smiles.

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“How is that even possible?” the woman coming out of the church wonders. She stops and talks with the lady.

No denying it. The flower seller has suffered. She reveals that. But Easter has just happened. What comfort there is in that. The pain and horror of Good Friday were turned into the power and mystery of the Resurrection. The magic of three days. “Whatever has happened to you,” she says, “just wait three days.”

As has often been pointed out, it’s the women in the Bible who witnessed the horror first-hand; Mary Magdalene, the other Mary, Mary the mother of Jesus, other women. It depends on which gospel account you’re reading. None of Jesus’s disciples are depicted as witnessing the crucifixion. It’s the women who stick it out, as awful as it must have been.

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But then, who are the first ones to witness the empty tomb, as they go there on the first day of the week, bringing spices to anoint the body, and find that the huge stone guarding it has been rolled away? It’s the women. An angel tells them that Jesus was raised from the dead. They were supposed to go tell the men. As the Gospel of Mark puts it, “They went out and fled from the tomb, for terror and amazement had seized them…”

(In the Gospel of John’s account, Mary Magdalene, sitting there weeping, actually sees the risen Jesus, but doesn’t recognize him until he says her name, “Mary.” Wow, isn’t that powerful? We know who Jesus is when he calls us by name.)

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Every year our church does a three-hour service on Good Friday. Ugh. I go and hear the gospel story. Sometimes fellow parishioners act out the passion story. It is all so sad. Must we retell it, re-live it, year after year?

And yet, in all of this, there is a helpful lesson. Yes, we do go through pain. We do witness terrible suffering. It’s important not to run away from it and hide. Recognize it. Take it in. Deal with it. See if and what it might be teaching you. As the wonderful priest and teacher Richard Rohr puts it, we learn from two things: love and suffering.

Note to self: Be aware of your own suffering and the world’s suffering. For there is something profound on the other side. You will see truth in all its wonder and beauty. What do you have to do? Just wait. Go for a walk. Sit in quiet meditation. Put away the phone for a while. Talk to a caring friend. Pick up a book. Put it down. Whatever. Wait a few days.

Wait three days. No telling what you will see.

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There is an old joke that scientists switched from lab rats to lawyers because you do not get as attached to lawyers. President Donald Trump has shown the same tendency to avoid becoming attached to either private or government counsel. Attorney General Pam Bondi is only the latest in a long line of lawyers let go by a president who was made famous with the tagline “You’re fired.”

There is no evidence of bad blood between President Trump and Bondi. The attorney general has been attacked over her loyalty to the president and has been by his side in some of the most precarious moments, from impeachment to criminal defense. As his “apprentices” learned, this is not personal. It’s business.

Jeff Sessions. Rex Tillerson. Bill Barr. Mark Esper. Kristi Noem. Trump’s Cabinet picks are known more for shelving than storage.

Indeed, being a cabinet member in a Trump administration is about as secure as being a quarterback for the Cleveland Browns.

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Trump has always viewed terminations as a way to spur higher performance levels.

There is a reason why Trump may have wanted to move now in swapping out attorneys general. There are growing predictions that the Democrats will lose the House and could now lose the Senate.

Democrats are running on pledges to unleash a new spasm of investigations and impeachments, targeting not just President Trump but anyone who supports him.

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Figures like Susan Rice, top policy adviser to both Presidents Barack Obama and Joe Biden, have promised “revenge” against all those who pushed Democrats out of power and warned that “it’s not going to end well for them.”

Sen. Chris Murphy, D-Conn., pledged that, as soon as they regain power, they will start throwing Trump people in jail when they retake Congress.

Democratic strategist James Carville previously threatened that “collaborators” may be treated in the same way as they were after World War II.

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Trump’s ability to secure confirmation of a successor will become far more challenging as he approaches the midterm elections.

Trump has to decide who will be the best hand on the wheel in those choppy waters ahead.

Acting Attorney General Todd Blanche has the street cred that Trump values. An accomplished litigator and former prosecutor, Blanche is neither flashy nor gregarious. He is a lethal litigator who can gut you like a trout without breaking a sweat. He has been at the president’s side in and out of court. While he will be a lightning rod for Democrats who have attacked him for his role in the release of the Epstein files, his firmness in dealing with a hostile media likely appealed to the president.

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Blanche offers a seamless transition for the department. He literally only has to walk down the hallway to take the reins from Bondi.

Another name reportedly under consideration is EPA Administrator Lee Zeldin, who would likely be the easiest to confirm and the most popular with members of Congress. Zeldin transformed the EPA in short order, including clearing away barriers to increasing energy production. Almost elected governor of New York, Zeldin has cross-over appeal in Washington as someone who cut his teeth in this town.

Other candidates include state attorneys general, as well as wild cards like U.S. Attorney Jeanine Pirro, a former judge with a tough-as-nails reputation in Washington, D.C. It is a deep bench.

There will be no shortage of applicants for the job. The office of the attorney general in the Trump administration has everything that one could want in Washington. Everything, that is, except job security.

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