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Walgreens and Prothena have announced a collaboration to enhance patient recruitment for Prothena's PRX012, a potential Alzheimer’s treatment currently in the ASCENT-2 clinical trial. Walgreens will utilize its extensive network and healthcare capabilities to identify suitable candidates, focusing on underserved communities. This trial has received Fast Track designation from the FDA, indicating its potential significance in addressing Alzheimer’s disease, which affects over 6.5 million Americans aged 65 and older. The partnership aims to create a more diverse patient population for the trial, aligning with the ENACT Act to improve inclusivity in Alzheimer’s research. Key topline data from ongoing Phase 1 studies is expected by the end of 2023.
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Collaboration between Walgreens and Prothena to enhance patient recruitment for PRX012 clinical trial.
Fast Track designation granted by FDA for PRX012, highlighting its potential importance.
Focus on increasing representation in Alzheimer's disease trials, addressing historical disparities.
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Insights-driven approach aims to support patient awareness, participation and representation in a clinical trial of Prothena’s Alzheimer’s drug candidate PRX012
DEERFIELD, Ill. & DUBLIN--(BUSINESS WIRE)--
Walgreens and Prothena today 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.
For more information on Alzheimer’s disease, please visit Walgreens.com.
For more information about the ASCENT clinical trial, visit ASCENT-AD.com.
About Walgreens
Walgreens (www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader with a 170-year heritage of caring for communities. WBA’s purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nation’s medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in communities nationwide.
About Prothena
Prothena Corporation plc is a late-stage clinical biotechnology company with expertise in protein dysregulation and a pipeline of investigational therapeutics with the potential to change the course of devastating neurodegenerative and rare peripheral amyloid diseases. Fueled by its deep scientific expertise built over decades of research, Prothena is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. Prothena’s pipeline includes both wholly-owned and partnered programs being developed for the potential treatment of diseases including AL amyloidosis, ATTR amyloidosis, Alzheimer’s disease, Parkinson’s disease and a number of other neurodegenerative diseases. For more information, please visit the Company’s website at www.prothena.com and follow the Company on Twitter @ProthenaCorp.
1“2022 Alzheimer's disease facts and figures.” Alzheimer's & dementia : the journal of the Alzheimer's Association vol. 18,4 (2022): 700-789. doi:10.1002/alz.12638
2Kornblith E, Bahorik A, Boscardin WJ, Xia F, Barnes DE, Yaffe K. Association of Race and Ethnicity With Incidence of Dementia Among Older Adults. JAMA. 2022;327(15):1488–1495. doi:10.1001/jama.2022.3550
3Langbaum, Jessica B et al. “Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials.” Alzheimer's & dementia : the journal of the Alzheimer's Association, 10.1002/alz.12737. 10 Aug. 2022, doi:10.1002/alz.12737
What is the purpose of the ASCENT-2 clinical trial for PRX012?
The ASCENT-2 trial aims to evaluate the safety and tolerability of PRX012, a potential anti-amyloid beta antibody for Alzheimer’s treatment.
How will Walgreens support Prothena in the ASCENT-2 trial?
Walgreens will leverage its national network to match patient populations to the trial, focusing on underserved communities.
What significance does the Fast Track designation by the FDA hold for PRX012?
The Fast Track designation indicates that PRX012 may address unmet medical needs in Alzheimer’s disease and can expedite its development process.
What is the expected timeline for topline data from the ongoing PRX012 studies?
Topline data from the ongoing Phase 1 studies of PRX012 is expected by the end of 2023.
What is the ENACT Act and how does it relate to the ASCENT-2 trial?
The ENACT Act aims to boost participation of underrepresented populations in Alzheimer’s clinical trials, which aligns with the recruitment efforts for the ASCENT-2 trial.
