(Stefanie Drenkow-Lolies, Pixabay)
31 July 2018. Early results from a clinical trial show an experimental antibiotic drug helps more people achieve remission of their Crohn’s disease for longer periods than a similar group given a placebo. However, fewer than half of the participants in the trial report effective results from the drug code-named RHB-104 developed by RedHill Biopharma Ltd., the company that sponsored the trial, and few findings about adverse effects were released.
RedHill Biopharma — in Tel Aviv, Israel and Raleigh, North Carolina — develops therapies mainly for gastrointestinal disorders, including Crohn’s disease, an inflammatory bowel disorder. Crohn’s disease usually effects the ileum, the last segment of the small intestine, as well as the colon. Symptoms can occur with little warning, ranging from mild to severe, and include abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition.
Crohn’s disease is often considered an autoimmune disorder, where the immune system is tricked into attacking healthy cells and tissue, instead of invading pathogens. RedHill’s experimental drug RHB-104 is designed as an antibiotic to treat infections from the subspecies paratuberculosis of the Mycobacterium avium, a bacterium in the same family as tuberculosis and leprosy. Mycobacterium avium subspecies paratuberculosis is believed to be a trigger of immune system reactions causing Crohn’s disease symptoms.
These bacteria are also linked to a similar disease in dairy cattle called Johne’s disease, and while a small percentage of dairy herds show signs of the disease, as many as 9 in 10 cattle may carry the microbe. A meeting of clinicians and researchers at Temple University in March 2017 identified Mycobacterium avium subspecies paratuberculosis as a zoonotic microbe, one able to jump from animals to humans, and a threat to both animal and public health.
The clinical trial enrolled 331 individuals with moderate to severe Crohn’s disease in 103 locations worldwide. Participants were randomly assigned to receive 5 RHB-104 capsules or a placebo, twice a day, as well as their usual medications. Participants were rated on their Crohn’s disease symptoms using a standard Crohn’s Disease Activity Index scale at 4, 6, and 12 months after starting the treatments, looking primarily for the number of participants able to reduce their symptom ratings below 150, considered remission level, after 6 months.
RedHill reported topline results from the trial showing on this main indicator, 37 percent of participants receiving RHB-104 achieved remission after 6 months, compared to 23 percent for placebo recipients, a large enough difference to be statistically reliable. The results, however, show beginning at 4 months of treatment, no more than 42 percent of the RHB-104 recipients achieve remission, and that percentage declines over time, even though more of the experimental drug recipients stay in remission than those taking the placebo. By 12 months after starting treatments, 18 percent of RHB-104 recipients are continually in remission since month 4, compared to 9 percent of placebo recipients.
The company also gave few details about adverse effects. RedHill says RHB-104 was generally safe and well-tolerated, with treatment and placebo groups experiencing similar low rates of adverse effects and discontinued participation in the trial.
RedHill says it’s continuing the trial with participants who did not achieve remission in the first 6 months, and plans further clinical studies before submitting a new drug application to FDA. The company still expects to discuss the trial’s findings with FDA and potential, but unnamed, partners for RHB-104.
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