Quadrant Biosciences, Autism Speaks to Study Minocycline as Autism Treatment

Quadrant Biosciences announced its collaboration with the Autism Speaks Autism Treatment Network (ATN) and its university research partners on research into the treatment of autism spectrum disorder (ASD). The ATN is a collaboration of Autism Speaks and some of the finest children’s hospitals and academic institutions in North America, specializing in multi-disciplinary medical care for children with autism. This Signature Study, including researchers from the Cincinnati Children’s Hospital Medical Center, University of Pittsburgh, and University of Missouri, is looking at the treatment of autism symptoms with the antibiotic minocycline. In addition to providing financial support for this important study, Quadrant Biosciences will be collecting salivary RNA data to further its work on epigenetic factors associated with ASD.

Prompted by earlier studies, researchers at the Cincinnati Children’s Hospital Medical Center initiated a study looking at the effects of minocycline treatment on ASD symptoms.

"While the etiology of ASD remains poorly understood in the majority of cases, a growing body of literature implicates neuroinflammatory mechanisms in the pathophysiology of the disorder," said Dr. Logan Wink, Associate Professor, Division of Child and Adolescent Psychiatry at Cincinnati Children’s Hospital Medical Center and Principal Investigator on this study. "Moreover, minocycline readily crosses the blood-brain barrier and is known to have direct neuroprotective effects as well as anti-inflammatory properties."

Given these characteristics, animal researchers hypothesized that minocycline treatment would improve autism symptoms. Researchers saw improvement in many classic autism symptoms such as aberrant social interaction, exploratory behavior, locomotion, and anxiety behaviors in various mouse models of ASD treated with minocycline. Additionally, trials in humans with Fragile X Syndrome-associated ASD have demonstrated improvement on the Clinical Global Impression Improvement subscale. These compelling results prompted the initiation of the present Autism Speaks ATN Signature Study.

"With the literature yielding evidence of symptom improvement with minocycline treatment, we felt it warranted further investigation," said Donna S. Murray, Ph.D., Vice President of Clinical Programs and head of the Autism Treatment Network. "It also fit perfectly with the ATN philosophy of collaborating with highly regarded children’s hospitals and academic institutions to develop evidence-based treatments that can be quickly translated into practice."

Quadrant Biosciences had been independently conducting research at SUNY Upstate Medical University and Penn State College of Medicine looking at epigenetic diagnostic biomarkers for ASD. That research, funded in part by the NIH, identified specific poly-omic RNAs that could accurately differentiate children with ASD from peers with typical development and non-autistic developmental delay. These findings led to the development of a simple saliva test to aid the early diagnosis of autism, which will be commercially available later this year.

The Autism Speaks ATN research also received support through the ATN’s role as the federally funded Autism Intervention Research Network for Physical Health. The clinical trial to begin later this year will involve a 24-subject, double-blind, placebo-controlled, four-week crossover study of minocycline in youths with ASD ages 12 to 22 years.

The study aims to:

1. Determine if minocycline use will be associated with reduction in elevated EEG gamma power in persons with ASD compared to placebo;
2. Assess the short-term safety and tolerability of minocycline in youths with ASD; and
3. Better understand the efficacy and dosage of minocycline for the short-term treatment of memory, social gaze, psychophysical markers, attentional impairments, quality of life, and other concerns in adolescents with ASD.

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