Clinical Trials

Blum Study by Curemark

The Blum Study is a phase 3 clinical trial sponsored by Curemark that is looking to determine whether the investigational drug CM-AT is safe and effective in treating symptoms of autism spectrum disorder (ASD). CM-AT was designed to release chymotrypsin in the small intestine and use the gut-brain connection to treat symptoms of ASD by aiding in the digestion of protein, and therefore increasing the pool of amino acids used in the production of key neurotransmitters and receptors in the central nervous system. This trial consisted of a 14-week double-blind, randomized, placebo-controlled study followed by the option to enroll in an open-label extension study. Enrollment for this clinical trial is now closed.

Tapestry Study by Axial Therapeutics

This phase 2b clinical trial sponsored by Axial Therapeutics is a double-blind, randomized, placebo-controlled study evaluating the safety, tolerability, and efficacy of AB-2004 in treating irritability associated with autism spectrum disorder in adolescents aged 13-17. The hypothesis is that certain neuroactive microbial metabolites produced in the gut can reach the brain and negatively affect behavior. AB-2004 acts to sequester these metabolites in the gut to reduce systemic and brain exposure.