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Trial Results

Vivitrol Helps HIV Patients Reduce Alcohol Intake

August 13, 2018

Monthly injections of the anti-addiction drug naltrexone (brand name Vivitrol) may help HIV-positive patients cut down on heavy drinking but it doesn’t help them stick to their med schedules, Yale researchers found. Researchers recruited 51 HIV patients for a four-year trial; all were heavy drinkers and strayed from their daily treatment plans. During the trial, patients received monthly naltrexone injections and regular counseling. The findings, published the journal AIDS and Behavior: Naltrexone helped patients reduce heavy drinking days. But it didn’t improve their antiretroviral adherence. Antiretroviral drugs have converted HIV and even AIDS from deadly diseases into chronic ones. But they only work if patients take them at least 95 percent of the time, researchers said.

Are Crickets Good for You?
Researchers may have found a healthy new addition to a complete breakfast: crickets. In what may be the first trial of its kind, University of Wisconsin researchers studied the effects of eating cricket and found it may help humans produce a key probiotic and reduce inflammation. Nearly 2 billion people worldwide eat insects as part of their everyday diet and the habit is slowly spreading to Europe and the U.S. Advocates of a bug diet say it’s a good way to get relatively cheap, high-density protein without the harmful health and environmental effects of livestock farming. But until now, no one had ever studied it in clinical trials. For their study, researchers split 20 healthy participants, ages 18 to 48, into two groups. One set ate a controlled breakfast and the other a breakfast of muffins or shakes made with 25 grams of powdered crickets for two weeks. All participants then reverted to regular, cricket-free diets for two weeks during what researchers called the “washout period.” Finally, over two more weeks, the groups swapped menus: Those who initially ate breakfasts of bug bits switched to the cricket-free meals and vice versa. The findings, published in the journal Nature: At the end of the six-week trial, participants had significantly higher levels of the probiotic Bifidobacterium animalis and lower levels of TNF-a — a cell-signaling protein linked to inflammation. Researchers caution the trial was small and say more study is needed. But the results are no doubt good news for the growing bug protein industry: According to the study, commercial bug farming is a $33 billion industry that’s expected to jump 40 percent over the next five years.

Phase II Trial of OV101 Promising
Ovid Therapeutics announced that the Phase II STARS trial of OV101 for Angelman syndrome achieved its primary endpoint of safety and tolerability. The study met its primary endpoint of safety and tolerability given that the adverse events (AEs) with OV101 treatment were similar to placebo treatment, with the majority of AEs being mild. The investigational medicine showed a favorable safety profile and was well-tolerated in adults and adolescents with Angelman syndrome. The Phase II STARS international study is a 12- week randomized, double-blind, placebo-controlled clinical trial, which randomized patients across three groups: a once-daily or twice-daily dose of OV101, or a placebo. Some 88 patients, aged 13 to 49, diagnosed with Angelman syndrome were randomized at 13 clinical trial sites in the U.S. and Israel. The study randomized patients to one of three arms: once-daily (QD) dose of OV101 at night (15mg), twice-daily (BID) dose of OV101 (10mg in the morning and 15mg at night), and a placebo at the pre-specified efficacy analysis. After 12 weeks OV101 showed a statistically significant improvement compared to placebo in the physician-rated clinical global impressions of improvement (CGI-I). CGI-I was ranked first in the topline statistical plan. The STARS trial explored the clinical utility of OV101 on improvements in clinical global impressions, maladaptive behavior, sleep, and gross and fine motor skills.

Positive Colitis Trial Results
Protagonist Therapeutics announced results from an independent blinded re-analysis of the Phase II PROPEL study of oral alpha-4-beta-7 integrin antagonist PTG-100 for the treatment of patients with ulcerative colitis (UC). The Phase IIb PROPEL trial was a global, randomized, double-blind, placebo-controlled, two-stage adaptive clinical trial to assess the safety, efficacy, and dose-optimization of three doses (150 mg, 300 mg, or 900 mg) of PTG-100 compared to placebo for 12 weeks in patients with moderate to severe ulcerative colitis. The primary efficacy endpoint of the study was the proportion of patients who achieved clinical remission as defined by rectal bleeding, stool frequency, and endoscopic subscores of the Mayo score. No safety concerns were noted with PTG-100. The data from blinded endoscopy re-reads and a comprehensive data review provide signals of clinical efficacy and support further development of PTG-100. Results showed independent, blinded histological scores favor PTG-100 over placebo and correlate with the clinical remission and endoscopic response outcomes from the re-analysis.