Allon granted U.S. patent for davunetide as a treatment for schizophrenia
Allon Therapeutics Inc. announced that an important United States patent has been issued covering the method of use for the company’s lead product davunetide and its associated neuroprotective technology platform as a treatment for schizophrenia.
Allon is more than halfway enrolled in a pivotal Phase 2/3 clinical trial with davunetide in progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). PSP is a rapidly progressing and fatal degenerative brain disease which is often misdiagnosed as Parkinson’s or Alzheimer’s disease.
Alistair Stewart, Allon’s Vice President of Commercial Research, said this additional U.S. patent reinforces the commercial market potential of davunetide in disorders outside of dementia which are also associated with neurodegeneration and cognitive decline.
“In a Phase 2a trial testing davunetide as a potential treatment for cognitive-impairment associated with schizophrenia (CIAS), we showed statistical significance on the UPSA test, a measure of functional capacity which is associated with activities of daily living. More recently, positive imaging data from a subset of subjects in the CIAS trial indicates changes consistent with a neuroprotective effect of davunetide. These data give us additional confidence that the broad activity of davunetide should target the core pathology in our on-going PSP trial and also lay the foundation for future work in schizophrenia.”
On July 19th, 2011, the Company announced new findings that 12 weeks of treatment with davunetide appears to prevent cortical thinning of important parts of the brains of schizophrenia patients. Allon has previously announced the presentation of imaging data looking at the biochemical changes that are thought to underlie the deficits seen in schizophrenia patients. For example, davunetide treatment produced a statistically significant increase in N-acetylaspartate (NAA), a putative marker of neuronal integrity known to decline in several neurodegenerative disorders including schizophrenia.
The patent granted by the United States Patent and Trademark Office covers the use and mode of delivery of davunetide, its parent protein ADNP and other derivatives of ADNP in mental diseases and disorders including schizophrenia.
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