US-based biopharmaceutical company Cassava Sciences has finished enrolling participants in a Phase III clinical trial of an oral drug candidate, simufilam, to treat Alzheimer’s disease.
The company enrolled a total of 804 patients with mild-to-moderate disease in the 12-month trial.
Simufilam attaches to the altered filamin A (FLNA) protein in the brain, thereby reinstating its usual activity and shape.
By acting on FLNA, the drug aims to improve health outcomes in Alzheimer’s patients.
Cassava Sciences expects to reach the target enrolment of nearly 1,100 subjects in another 18-month Phase III trial in the fourth quarter of this year.
These double-blind, randomised trials will assess the safety and efficacy of oral simufilam for dementia associated with Alzheimer’s.
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They have received a special protocol assessment from the US Food and Drug Administration.
Cassava Sciences chief medical officer James Kupiec said: “We are pleased to announce the completion of patient enrollment in our first pivotal Phase III trial of simufilam in Alzheimer’s.
“We are grateful to the patients, investigators and our CRO who have helped achieve this milestone.”
Cassava previously reported positive interim safety data from ongoing Phase III trials of simufilam for Alzheimer’s.
Following this, the Data and Safety Monitoring Board (DSMB) advised the company to proceed with both trials without any changes.
Cassava Sciences holds the global development and commercial rights for its Alzheimer’s programmes, as well as those of linked technologies, without royalty contracts with third parties.
Based in Austin, Texas, the company aims to detect and treat Alzheimer’s and other neurodegenerative diseases.
Cassava Sciences president and CEO Remi Barbier said: “Cassava Sciences is honoured to be developing a new drug treatment for people living with Alzheimer’s disease. Alzheimer’s is a medical condition with high unmet needs.
“It merits the development of drug innovations that aim to go beyond removing amyloid from the brain. We think simufilam is advancing towards that goal.”