Walgreens and Prothena have announced a collaboration to accelerate patient identification and recruitment for Prothena’s ongoing ASCENT-2 multiple ascending dose clinical trial evaluating the safety and tolerability of PRX012, a potential best-in-class anti-amyloid beta antibody under development for the treatment of Alzheimer’s disease. As part of the collaboration, Walgreens will leverage its national footprint, portfolio of industry-leading healthcare companies and compliance framework to match patient populations to this Prothena clinical trial for PRX012, which has been granted Fast Track designation by the U.S. Food and Drug Administration.
“Alzheimer’s disease is an incredibly complex disorder and requires all stakeholders to work together to develop and evaluate effective therapies,” said Ramita Tandon, chief clinical trials officer, Walgreens. “Through Walgreens trusted community pharmacy presence and daily interactions with millions of patients across America, we believe we can have a meaningful impact in helping Prothena with their clinical trial recruitment efforts. Our aim is to help build a more representative patient population for Alzheimer’s research, particularly among underserved and diverse communities, to create a better understanding of this disease.”
“The Alzheimer’s community is at the beginning of a transformational change as more treatment options become available to slow the progression of this devastating and fatal disease. At Prothena, we’re excited about PRX012 and the impact it could have as a next-generation Alzheimer’s disease treatment with the potential for more convenient administration for patients and caregivers,” said Hideki Garren, M.D., Ph.D., chief medical officer, Prothena. “This innovative partnership will allow Prothena to leverage Walgreens unique capabilities to engage a broader and more representative patient population for potential enrollment in ASCENT-2 and accelerate the development of the PRX012 program to bring this potential best-in-class anti-amyloid beta antibody to patients as soon as possible.”
Operating in nearly 9,000 locations, nearly half of which are in socially vulnerable areas, Walgreens pharmacy teams can help address patients’ specific needs and barriers to care. Using the company’s pharmacy and patient-authorized clinical data, Walgreens will identify and engage with potentially eligible patients and their caregivers where it is most convenient for them – in the pharmacy, at home or digitally – to educate them on Prothena’s ASCENT-2 clinical trial. Walgreens will then invite interested patients or their caregivers to complete a pre-screen to determine eligibility for participation at one of Prothena’s clinical trial sites.
These efforts align with the Equity in Neuroscience and Alzheimer’s Clinical Trials (ENACT) Act’s objectives of boosting the participation of underrepresented populations in Alzheimer’s and dementia clinical trials. In the United States, it is estimated more than 6.5 million people over the age of 65 are living with Alzheimer’s disease1. Studies show that Black and Hispanic older adults are at a significantly higher risk for developing Alzheimer’s disease than White older adults2, yet these populations have been historically left out of clinical trials3.
Prothena’s Phase 1 PRX012 single ascending dose (SAD) and multiple ascending dose (MAD) studies are ongoing with topline data expected year end 2023.