Lindsey Shapiro, PhD, science writer —

The U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting to discuss BrainStorm Cell Therapeutics‘ application to approve NurOwn for amyotrophic lateral sclerosis (ALS). Such a meeting, called an ADCOM, is normally for when a therapy is under regulatory review so experts can discuss its…

Treatment with CNM-Au8 significantly delayed clinical worsening in people with amyotrophic lateral sclerosis (ALS), according to new exploratory analyses from the therapy’s arm of the HEALEY ALS platform trial. The experimental therapy, from Clene Nanomedicine, had previously been found to reduce the risk of death by more…

Amyotrophic lateral sclerosis (ALS) patients treated earlier with CNM-Au8 in a clinical trial experienced a significantly slower disease progression than those who started treatment nine months later. These latest findings from the RESCUE-ALS Phase 2 trial (NCT04098406) and its open-label extension (OLE) study (NCT05299658) add to earlier reports that…

Early activation of certain cellular stress response pathways may help prevent the death of motor neurons in amyotrophic lateral sclerosis (ALS) patients with FUS mutations, according to a recent study. In particular, heat shock response (HSR) pathways and the integrated stress response (ISR) were increased in patient-derived motor neurons…

A small Phase 2 clinical trial is evaluating the safety and tolerability of investigational treatment candidate EPI-589 in adults with amyotrophic lateral sclerosis (ALS). The EPIC-ALS trial (jRCT2061210031), being conducted in Japan, will also assess exploratory effectiveness outcomes after six months of treatment. Data collection began in September…

The Phase 2b trial testing PrimeC in people with amyotrophic lateral sclerosis (ALS) will no longer enroll patients in the U.S., its maker NeuroSense Therapeutics has announced. Meanwhile, the company has been given the green light from regulatory agencies in Germany and Canada to enroll new participants,…

A Phase 1/2 clinical trial testing the investigational imaging agent 18F-OP-801 in healthy volunteers and people with amyotrophic lateral sclerosis (ALS) has enrolled its first patient. Ashvattha Therapeutics‘ agent is designed to detect inflammation in imaging exams like positron emission tomography (PET) or MRI scans. This is possible…

Adding a skin patch containing a Chinese herb mixture called Ji Wu Li (JWL) to standard medications significantly slowed disease progression in people with amyotrophic lateral sclerosis (ALS), according to data from a randomized clinical trial. In the trial, called ALS-CHEPLA (ChiCTR200037353), the benefits of the herbal treatment emerged…

Researchers have developed a brain-machine interface (BMI) that could someday facilitate communication for people who have lost their ability to speak, including those with amyotrophic lateral sclerosis (ALS). After being trained to recognize certain patterns of nerve cell activity, the BMI could accurately predict the words a person with…

Veterans with amyotrophic lateral sclerosis (ALS) are calling for the U.S. Food and Drug Administration (FDA) to hold a public advisory committee meeting to discuss the benefits of NurOwn — an investigational cell-based therapy that military service members say has slowed their disease. The request follows the regulatory…