Use of alpha-melanocyte-stimulating hormone (MSH) receptor agonists as an adjunct to psychotherapy for the treatment of autism, post-traumatic stress disorder, anxiety disorders and other behavioral disorders.
- Manipulating the oxytocin system in the brain has been shown to increase trust, generosity, empathy, socially reinforced learning and attention to comprehension of emotional expression.
- Potential clinical candidates exist which have already been dosed to humans.
- Provides novel potential treatment for autism and other behavioral disorders.
Between 2009 and 2017, the global prevalence rate for autism spectrum disorders (ASDs) is expected to increase from 4.3 million to 7 million people, and yet an effective therapeutic that addresses the core symptoms of ASDs is not available. Currently, two drugs, risperidone and aripiprazole, have been approved to help manage related ASDs symptoms, however there are no medications that can cure ASDs or even treat the main symptoms. Two potential therapeutics in Phase III clinical trials include a dopamine receptor antagonist and a GABAB receptor agonist. Overall, the market space remains uncrowded.
Pharmacological interventions such as antidepressants are often used as an adjunct to counseling/therapy to enhance response rates in patients with a number of behavioral disorders. Emory researchers have proposed that a pharmacological agent that manipulates the oxytocin system in the brain may enhance the results of behavioral therapy. Recent studies in humans have shown that administration of intranasal oxytocin significantly increases social interactions, feelings of trust, and the ability to interpret emotional expression in individuals with autism spectrum disorder. Oxytocin itself is rapidly metabolized by the brain and does not pass the blood brain barrier. Therefore, molecules that stimulate endogenous oxytocin release may be a more viable strategy to stimulate oxytocin receptors in the brain. Oxytocin neurons express MSH receptors and agonists to these receptors stimulate oxytocin release. The inventors have demonstrated that oxytocin receptor activation through a MSH receptor agonist, which has already been administered to humans in clinical trials for other indications, stimulates the formation of a pair bond between a mating pair of monogamous prairie voles. These results indicate that the MSH antagonist in combination with psychotherapy could potentially be used to treat behavioral disorders including ASDs.
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Proof of principle studies with a mammalian animal model have been completed. A pilot clinical trial involving subjects with autism using a lead candidate that has been previously dosed to humans is in the planning stages.