An experimental drug developed by First Tracks Biotherapeutics reduced symptoms and protected against gluten-induced intestinal damage in people with celiac disease, according to results from a small early-stage trial.
The 32 participants had been diagnosed with celiac disease at least a year earlier and were following a gluten-free diet, but biopsies showed they still had moderate intestinal damage.
Even trace amounts of gluten can trigger intestinal injury and debilitating symptoms, despite efforts to avoid it, the researchers said.
Participants received three injections of the drug, ANB033, or a placebo at the start of the trial, at week two and at week four. They then consumed 6 grams of gluten daily for two weeks, roughly equivalent to two slices of bread.
Biopsies taken at the end of the study showed statistically significant protection against intestinal damage among those who received the drug, compared with the placebo group, the company said.
The drug also prevented an increase in symptoms throughout the gluten challenge. Only 6 percent of patients receiving ANB033 needed permitted medication to relieve gastrointestinal symptoms, compared with 47 percent in the placebo group.
“It is remarkable to see, for the first time, both statistically significant prevention of symptoms and (intestinal) benefit in the same study,” said study leader Dr Benjamin Lebwohl of New York-Presbyterian/Columbia University Irving Medical Center.
ANB033 inhibits the immune cell proteins IL-15 and IL-2, which drive inflammation and intestinal damage. IL-2 is also closely linked to symptom development, Lebwohl said.
Researchers are assessing intestinal healing and symptom severity at 12 weeks in a second group of patients, with initial results expected early next year. The full findings are due to be presented at the International Celiac Disease Symposium in Melbourne next month.
Two recent studies have also challenged the idea that cannabis improves sleep.
One review examined nine trials involving 537 adults with insomnia who were randomly assigned medical cannabis, a placebo or an antidepressant. Medical cannabis showed little to no clinically meaningful improvement in sleep quality, satisfaction, total sleep time or daytime functioning compared with the other treatments.
The findings, published in The Cochrane Database of Systematic Reviews, were limited by differences in the cannabis products tested and the short duration of the trials, none of which followed participants for more than 12 weeks. Researchers rated the overall evidence as very low to low and said it could not reliably establish whether medical cannabis helps people with insomnia.
A separate study tracking 1,266 people from young adulthood into middle age linked long-term cannabis use to lower sleep quality, as measured by wrist-worn monitors.
Published in JAMA Network Open, the study also found that participants generally did not report worse sleep despite the nighttime disruptions detected by the devices.
A third study explored how artificial intelligence could help patients interact with medical monitoring equipment and better understand their conditions.
In a pilot study, 13 patients with epilepsy undergoing continuous brain monitoring used a smartphone app to ask questions about their brain activity, request charts showing data trends and receive alerts or surveys throughout the day.
The AI system could contact patients when it detected potentially important changes and adapt based on their responses.
Researchers analysed 1,307 messages exchanged between patients and the system over an average of about five days. Most discussions concerned seizures, sleep, mood, energy levels and other factors that could influence seizure activity.
Several participants said the platform helped explain patterns they had noticed but struggled to understand, including possible links between seizures and emotions. Patients could also identify seizures the system had correctly detected and flag false alarms, helping improve its accuracy.
The researchers, whose findings were reported in Nature Medicine, said the approach could have wider applications in cardiac devices, insulin pumps and emerging treatments for conditions including Parkinson’s disease, depression and addiction.
“We envision medical devices becoming partners in care that learn alongside patients and help them make better decisions every day,” said study leader Dr Brian Litt of the University of Pennsylvania.