Biotech company Prothena taps Walgreens to recruit patients for Alzheimer's drug research

Walgreens launched its clinical trials business nearly a year ago and now has five contracts with drug manufacturers.

The retail pharmacy giant notched a major partnership with Prothena to identify and recruit patients for the biotech company's Alzheimer’s disease drug candidate. Prothena’s anti-amyloid beta antibody, called PRX012, is being investigated in a phase 1 study for the potential treatment of Alzheimer’s. PRX012 has been granted fast-track designation by the U.S. Food and Drug Administration. 

Prothena’s phase 1 PRX012 single ascending dose and multiple ascending dose studies are ongoing with top-line data expected by year-end.

Walgreens plans to leverage its national footprint, growing portfolio of healthcare companies and compliance framework to match patient populations to the clinical trial.

The company operates about 9,000 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands, nearly half of which are in socially vulnerable areas, according to the company. More than 75% of Americans live within five miles of a Walgreens.

Ramita Tandon, chief clinical trials officer at Walgreens, said the retailer can leverage its vast pharmacy presence and daily interactions with millions of patients across the country to help Prothena with its clinical trial recruitment efforts, with a particular aim on building a more representative patient population for Alzheimer’s research that includes underserved and diverse communities.

"Prothena is very focused in the area of Alzheimer's, and, as we know, that is a very debilitating disease, particularly as we think about the Black and Brown patient populations. This partnership aims to help Prothena, particularly in their phase 1 trial, identify patients in some key geographic locations, particularly as they're looking to also advance and look for diverse patient populations," Tandon said in an interview. "This is an exciting time both for Prothena and for us as we start to unlock the patient population in Alzheimer's, but more importantly, get data on diverse patient populations and help to advance Alzheimer's research."

The industry has also recognized the need for more diversity in clinical trials.

The FDA is taking steps to increase racial and ethnic diversity in clinical trials given that 20% of drugs have a variation in responses across ethnic groups, yet 75% of clinical trial participants are white, while only 11% are Hispanic and fewer than 10% are Black and Asian.

Walgreens launched its clinical trials business back in June as the company's healthcare ambitions continue to grow. Other retailers including CVS, Walmart and Kroger have developed their own clinical trial programs as these companies see a large role for community pharmacies to play in advancing clinical trial research. It also marks a strategic way to grow their businesses in healthcare.

Tandon says there are opportunities to leverage Walgreens' vast stores of pharmacy and patient-authorized clinical data to help identify and recruit patients for drug research.

Walgreens plans to leverage these data to help identify and engage with potentially eligible patients and their caregivers 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 prescreen to determine eligibility for participation at one of Prothena’s clinical trial sites.

"We are making significant investments to create our data ecosystem, if you will, and we're bringing together the pharmacy records, the patient's clinical records, and Prothena wants to be very focused in certain geographic areas of interest," Tandon said. "We can get more precise about matching the right patients to trials versus just sending out mass mailers or advertising to see if there's interest. We're really putting a lot more intentional thought, technology and investments around curating the right patient population that we want matched to trials."

She added, "More importantly, it's giving us insight into going into areas that have high unmet needs or communities of color, communities that have never had access to clinical trials. We're really trying to use data and technology to enable us to get into those communities and start offering trials."

Walgreens can leverage its clinical records and analytics technology to develop a "real-world evidence engine," Tandon said. "Particularly with electronic medical records where you have access to both structured and unstructured data, if you bring that together, it really paints and provides a holistic picture of the patient's journey and sort of affords us to support a number of use cases," she said.

The retailer also can leverage its pharmacy locations as an accessible entry point for patients to learn more about clinical trials and sign up to participate in research, she noted.

In the U.S., it is estimated more than 6.5 million people over the age of 65 are living with Alzheimer's disease. Studies show that Black and Hispanic older adults are at a significantly higher risk for developing Alzheimer’s than white older adults, yet these populations have been historically left out of clinical trials. 

Walgreens is using lessons learned during the COVID-19 pandemic to form its strategies around community engagement, Tandon noted.

"We recognize it's not a one-size-fits-all strategy. Community engagement is quite critical in this process, so whether we're using email texting or making phone calls to patients to see if they're interested, we're putting in efforts to create that community surround sound," she said. "We recognize that not all communities embrace technology the same way. There are digital literacy variations and there are medical health literacy variations. As we start to go into the communities, we're starting to listen and learn and then start to make sure as we support the actual trial, we're mindful of the communities and using our local community partners to make sure that we're educating those communities, priming them up about what a clinical trial is and then getting them to feel empowered to make the decision to sign up and participate." 

“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 at Prothena, in a statement. 

“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," Garren said.