Allon Therapeutics Inc., a developer of treatments for neurodegenerative diseases, has announced that patient treatment has been completed in the multinational pivotal Phase II/III clinical trial that is evaluating the company's product davunetide as a potential treatment for progressive supranuclear palsy, or PSP.
The company is conducting the study under a special protocol assessment with the FDA meaning the data from this study can be used as part of a marketing approval for davunetide.
Allon estimates the market potential for the first approved treatment for PSP could exceed $700 million in the US and Europe.
The trial treated more than 300 patients at medical institutions in the US, Canada, the UK, France, Germany, and Australia. It is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
Allon president and CEO, Gordon McCauley, said "Achieving this milestone means the company is on track to release top-line data from the clinical trial in the second half of December."
McCauley added, "The positive data from the clinical trial would present Allon with several options, including pursuing regulatory approval in the US and other markets for PSP as well as define the opportunity to evaluate davunetide in other tau-related diseases, such as Alzheimer's, subtypes of frontotemporal dementia, as well as other neurodegenerative diseases such as schizophrenia and Parkinson's."