Biomarker data insufficient to support CNM-Au8’s approval: FDA

Early data from Phase 2 programs showing that CNM-Au8, an oral therapy candidate for amyotrophic lateral sclerosis (ALS), induced significant reductions in a nerve damage biomarker but did not meet the criteria for accelerated approval at this time, the U.S. Food and Drug Administration (FDA) concluded. Despite the…

After I finished this holiday season’s wreath orders, I moved my wreath-making table out of the dining room back into the garage and put away extra pine cones, bows, and birch bark. The room felt spacious without the clutter, and I told my husband, Todd, “This reminds me of the…

LifeArc, a U.K.-based independent medical research charity, is offering £5 million (about $6 million) to scientists around the world as part of a grant program to tackle motor neuron disease (MND) using repurposed or combined medicines. The program is part of the Motor Neuron Disease Translational Challenge, which…

Scientists at King’s College London have identified the site in motor neurons that appears to be the starting point of dysfunction in amyotrophic lateral sclerosis (ALS) — shedding new light on the workings of the neurodegenerative disease at its earliest stages. “This provides a better understanding of the complex…

What if I told you that eating sugar cookies and cherry pie could help slow down the progression of ALS symptoms? You’d probably say, “Hey Dagmar, you’ve gone bananas!” I know, I know. The suggestion sounds contrary to what we’ve always been told about healthy eating, especially for anyone…

People with amyotrophic lateral sclerosis (ALS) given PrimeC in the PARADIGM Phase 2b trial — and who did not diverge in major ways from the trial’s rules — experienced a significant slowing in disease progression compared with a placebo, the treatment’s developer, NeuroSense Therapeutics, announced. This finding…

Treatment with Relyvrio (sodium phenylbutyrate and taurursodiol) significantly reduced blood levels of neuroinflammatory biomarkers in people with amyotrophic lateral sclerosis (ALS) as early as three months, according to a post hoc analysis of the CENTAUR trial. Data from the Phase 2 study (NCT03127514) demonstrated that reductions in…

BrainStorm Cell Therapeutics has had a meeting with the U.S. Food and Drug Administration (FDA) seeking an agreement on its plans for a confirmatory Phase 3b trial of NurOwn, a cell-based treatment the company is developing for amyotrophic lateral sclerosis (ALS). The main goal of the meeting,…

A few weeks before Christmas Day in 2018, my late husband, Jeff, and I sat side by side on the edge of our bed, preparing to create the most meaningful Christmas gifts we’d ever given. Laid out beside us on the bed were four children’s storybooks, each with a Christmas…

“The essence of trauma is powerlessness.” This quote from Christian trauma therapist Colleen Ramser grabbed my attention, because I often feel powerless as a caregiver for my husband, Todd, who is paralyzed by ALS. We’ve been having a rough week. Todd’s shower aide called in sick a…