NPL-2510: Autism Diagnostic

The program

Neuropharm is working with a University based research program that has identified abnormal chemical variations in small proteins in the saliva of approximately two-thirds of individuals on the Autistic Spectrum.

Additional research regarding the application of this finding is ongoing and Neuropharm has retained an exclusive option to license this novel approach.

The market

It is estimated that there are more than 1.8 million cases of Autism Spectrum Disorders in the US and around 2.8 million cases in the EU.

According to the US Center for Disease Control, the current approach to diagnosing an Autism Spectrum Disorder is generally a two-stage process. The first stage involves developmental behavior screenings which take place during “well child” check-ups. The second stage includes a more comprehensive evaluation by a multidisciplinary team but is also based on behavioral assessment.

It is generally believed that Autism does not have a singular underlying cause, thus, identification of a single bio-marker is unlikely. However, a non-invasive objective biologically based diagnostic screening test, that has the potential to identify a significant sub-population, would represent a valuable adjunctive option for clinicians.

This technology is complementary to other objective biological test under development.

Our progress

A highly qualified academic based research team has developed the diagnostic screening technology and is continuing studies to evaluate the potential for identification of specific markers for Autism.

Neuropharm is in the process of developing a validation and regulatory plan, in anticipation of bringing the product to market in both Europe and the US.

Key points

• There is a significant need for biologically based diagnostic tools in Autism.
• A measure of the salivary proteome has the potential to help distinguish people in Autism from individuals who are unaffected by the Autism Spectrum Disorders.
• A non-invasive, biologically based idagnostic screening tool intended to supplement current diagnostic protocols for Autism would be of significant interest to patients, practitioners and payers.

Market opportunity

• There is an acute need for non-invasive biologically based diagnostic tests to aid in the diagnosis of Autism Spectrum Disorders.
• NPL-2510 represents an exciting near-term global opportunity with significant market potential.