The German biopharmaceutical company, Exciva GmbH, has announced the dosing of the first patient in its Phase 2/3 SERENADA trial.

The study is being conducted at Esperanza Clinical in Murrieta, California, and aims to evaluate the safety and efficacy of Deraphan for treating agitation in patients with Alzheimer’s disease (AD) dementia.

“We are proud to announce the dosing of the first patient in SERENADA. We are thankful to Dr Michael Ropacki and the team at Esperanza Clinical for their role in supporting us in developing new treatment options for patients with AD dementia. With its promising therapeutic potential, it could pave the way to treating agitation in other neuropsychiatric disorders,” said François Conquet, CEO of Exciva.

“We are equally delighted to welcome Dolby Ventures as a new investor. This growing support reflects the strong confidence in Exciva’s clinical strategy to treat the neuropsychiatric symptoms in AD,” he added.

Agitation and other behavioral and psychological symptoms associated with Alzheimer’s disease pose a significant burden on patients and caregivers. Despite the severity of these symptoms, there are currently limited treatment options available for managing agitation in AD patients.

Exciva’s therapeutic strategy avoids targeting the dopaminergic system, potentially reducing risks such as cognitive decline, morbidity, and mortality. If successful, Deraphan could offer a novel treatment approach aimed at improving the quality of life for individuals living with Alzheimer’s disease.

In parallel with the trial’s initiation, Dolby Ventures has joined as a new investor, bringing Exciva’s Series B funding round to a total of €53 million ($62 million).

“Exciva’s approach to targeting neuropsychiatric symptoms, in particular agitation in Alzheimer's patients, addresses a critical unmet need in Alzheimer’s care,” said Reetika Bhardwaj, Principal at Dolby Ventures. “Our investment in Exciva underscores our commitment to advancing therapeutic treatments in neurodegenerative diseases, which have profound societal and economic implications, and providing support for AD patients and carers worldwide.”