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news.Allon Therapeutics has updated the progress of the pivotal Phase 2/3 clinical trial which evaluates the company's neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP).
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The trial is being conducted under a Special Protocol Assessment (SPA) granted by the US Food and Drug Administration (FDA), which ensures that the agreed clinical trial design meets the FDA’s expectations for a pivotal study.
Allon president and CEO Gordon McCauley said the pace of enrollment is a testament to the patients, caregivers, investigators, and advocacy groups who have been tremendous partners, and certainly hope this trial to generates data necessary for marketing approval of davunetide as a treatment for PSP.
The multi-national study is being conducted at premier medical institutions in the US, Canada, the UK, France, Germany and Australia.