US regulators have assigned Elan's early-stage Alzheimer's candidate fast-track designation, which could give the drug a faster route through the review process.
The move, which is designed to facilitate/accelerate the development of new drugs for serious or life-threatening conditions that address unmet medical needs, not only enables more frequent dialogue with the FDA but also indicates that a priority review may be given.
ELND005 is an orally bioavailable small molecule which is being developed to treat neuropsychiatric symptoms (NPS) in Alzheimer’s disease, which develop in about 90% of patients.
The drug has a dual mechanism of action, including the prevention of beta-amyloid build-up and regulation of myoinositol levels in the brain.
The clinical programme includes the Phase II Study AG201 in patients with AD, who are experiencing at least moderate levels of agitation/aggression, and the safety extension Study AG251, the firm said.
Elan had planned to spin-off ELND005 into a new company called Speranza, under a trio of moves designed to protect itself from being snapped up by Royalty Pharma. However, shareholders rejected the idea last month.