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Science of AB-2004

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Finding answers in the gut

A growing body of scientific research has validated that changes and irregularities in gut bacteria – also called the “gut microbiome” – plays a role in the progression, causes, and symptoms of certain neurological conditions, including irritability associated with autism. A team of scientists, including those at Axial Therapeutics, has shown that this link may be due to certain substances produced by gut bacteria. This research is the foundation for Axial Therapeutics’ potential new treatment for irritability in children with Autism Spectrum Disorder (ASD).

AB-2004 has potential as a novel therapeutic approach for ASD-related irritability.

The gut-brain connection in ASD

Studies have revealed that there is a significant difference in the gut bacteria of children with autism compared to those children who are not on the autism spectrum. This difference may lead to higher levels of certain substances, known as metabolites, that are produced by bacteria in the gut. When these substances enter the bloodstream and reach the brain, it is possible that they contribute to characteristics often associated with autism, such as irritability.

AB-2004, Axial’s investigational therapy being studied in this trial, is designed to reduce the substances that earlier research has shown may be linked to ASD-associated characteristics. AB-2004 is designed to act in the gut only, selectively adsorbing metabolites before they enter the bloodstream and reach the brain. Since AB-2004 works in the gut and does not enter other bodily tissues, it lessens the potential for side effects across other parts of the body. In a previous clinical study involving adolescents diagnosed with autism, AB-2004 was shown to be safe and well tolerated.

ABOUT AB-2004

Harnessing the Connection Between the Gut and the Brain

AB-2004 is Axial Therapeutic’s lead investigational therapy that targets the microbiome gut-brain axis and its role in co-occurring conditions associated with Autism Spectrum Disorder (ASD). AB-2004 is a gut-targeted, molecular therapeutic, which means it is designed to work in the gut only and does not enter other bodily tissues. We believe this mechanism may result in minimal side effects due to lack of exposure across other parts of the body, although this hypothesis needs to be verified in controlled clinical trials.

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Novel Medical Solution for Irritability in Autism

AB-2004 is being studied as a potential new treatment for managing irritability associated with ASD in children. Irritability is a common co-occurring condition in children with autism for that limited treatment options currently exist and those that are approved can have significant side effects. 

 

Scientific evidence has shown there may be a link between bacteria commonly found in the digestive tract, and the brain which could contribute to certain characteristics, such as irritability, in children with ASD. AB-2004 is designed to adsorb certain substances produced by gut bacteria to reduce their ability to enter the bloodstream and reach the brain.   

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Innovative Product to Improve Lives

The active ingredient in AB-2004 is a highly engineered form of spherical carbon designed with human safety and biological selectivity in mind, making it very different from activated charcoal. Each sphere of AB-2004 consists of a network of pores that allows it to selectively adsorb metabolites that may contribute to characteristics associated with ASD like irritability and anxiety.

AB-2004 is a tasteless and odorless powder formulation that can be mixed with soft food which makes taking the medication very easy. Finally, AB-2004 will not discolor your hands or your food.

AB-2004 has several critical attributes that make it potentially ideal for chronic clinical use and differentiate it from activated charcoal available over the counter.

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AB-2004

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activated charcoal

Commitment to Patient Safety

AB-2004 is produced using a manufacturing process that meets the highest global standards for safety and quality. This highly controlled manufacturing process, done under strict regulatory control, guarantees the highest level of product quality.

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Body of Medical Evidence

AB-2004 is being studied for irritability associated with ASD based a growing body of scientific evidence showing bacterial substances produced by bacteria commonly found in the gut can contribute to characteristics like irritability and anxiety. In a previous clinical study involving autistic adolescents, AB-2004 was shown to be safe and well tolerated. AB-2004 was also shown to reduce several key microbial metabolites implicated in autism and showed evidence of improving key co-occurring conditions, including irritability and anxiety.

CLINICAL-TRIAL IN IRRITABILITY

Learn more about our study investigating this potential treatment in ASD-related irritability.

SEE IF YOUR CHILD QUALIFIES

We are currently evaluating eligible children for the clinical trial at sites across the U.S.

ANSWERS TO YOUR IMPORTANT QUESTIONS

It’s a big step for your child and family to enroll in a clinical trial. Here’s helpful information to ease your decision-making.