In an exclusive interview with The Fly, Prothena (PRTA) CEO Gene Kinney talked about the company, its pipeline, the Alzheimer's disease space, COVID-related challenges and much more.
ALZHEIMER'S DISEASE TREATMENTS: Prothena has a portfolio of programs for the potential treatment of Alzheimer’s disease, including PRX012 that targets the beta-amyloid peptide and the company’s dual Aβ-tau vaccine. "We've been studying Alzheimer's disease for quite some time. PRX012 targets a protein known as amyloid beta and it does so in a very specific way. And what we're looking to do with PRX012 is really to add value back to society by thinking of a more convenient administration. Our targeted product profile is subcutaneous administration at home at a convenient schedule. This also allows caregivers who have the desire to go back to the workforce to do so," CEO Gene Kinney explained to The Fly.
"We also have other assets in our portfolio such as PRX005 which is in the clinic and addresses the tau protein, also important in Alzheimer's disease. Addressing tau gives us another opportunity to influence in a positive direction the disease progression involved in Alzheimer's disease. But also, one can think about combining these approaches to push forward the benefit we can provide to patients. And in that regard, we have a third approach in our portfolio which is an active vaccination approach. This is a single vaccine that allows us to generate an appropriate response to what we consider to be the appropriate part of the amyloid protein and tau protein," the executive added.
Prothena expects to start producing data from its PRX005 trial this year. The company also guided that it will file an IND, or Investigational New Drug, application for PRX012 this quarter and is "on track to do so," according to Kinney. "We expect to be able to start sharing data from that molecule next year. And we're anticipating the potential to file an IND for our vaccine in the next year," he added.
PERIOD OF TRANSITION: Prothena's stock quadrupled in 2021, in large part based on expectations around the Alzheimer’s portfolio. CEO Kinney believes the space is entering a "period of transition." "Just a couple years ago the only treatments for Alzheimer's disease patients were treatments to address symptoms but had no impact in the underlying disease progression. With the accelerated approval of [Biogen's (BIIB)] Aduhelm last year, I think what we're seeing now is a transition in this space to the first generation of disease modifying agents. To me it is a very exciting moment. But it's seldom a straight line, there are always challenges to overcome."
On Tuesday, the Centers for Medicare & Medicaid Services posted its draft National Coverage Analysis for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease, proposing to cover Food and Drug Administration approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease under Coverage with Evidence Development in CMS approved randomized controlled trials that satisfy the coverage criteria, and in trials supported by the National Institutes of Health.
"We heard about the draft coverage on [Tuesday] night. In April, we look forward to seeing what the final coverage determination looks like and whether it changes from the draft or not. We have some important datasets coming out this year as well. And Eli Lilly [LLY] with its donanemab program is also engaging with regulators around potential pathways for potential approval of their molecule this year and we expect their dataset next year. These are exciting moments for the field as well," Prothena's CEO added.
IMPORTANT EVENTS AHEAD: Prothena's Phase 3 trial for birtanimab, which is being developed for Mayo Stage IV AL Amyloidosis patients, is now enrolling and the company anticipates top-line data from that study in 2024.
"We're working with a number of partners in this space as well. We have a therapy is in clinical development that Phase 2b study for the treatment of Parkinson's disease. That's a program that is partnered with our colleagues at Roche [RHHBY]. That is moving forward as well and is currently enrolling. We expect data sometime in the 2024 timeline as well. This year, we expect to put PRX012 into the clinic. We anticipate an IND filing with the FDA in the first quarter and we're on track to deliver that. We anticipate that for our tau-targeting agent, which has the potential for treatment of the Alzheimer's disease as well and is a program partnered with Bristol-Meyers [BMY], we will start to report data from the study - initiated last year – this year, which will give us a sense of the safety and tolerability of that molecule, as well as the pharmacal dynamic effect. Finally, we continue to move forward with our active vaccine approach. We think that's a very important molecule," the executive explained to The Fly.
NO COVID-RELATED DELAYS: The ongoing pandemic has presented new challenges to the clinical development space but Prothena has yet to see any major COVID-related impact or delays in its clinical studies. "At this point in the pandemic, we have been able to anticipate some of those challenges. By circumstance, a number of our clinical trials weren’t at a critical junction when the pandemic started. So, we had the opportunity to adjust to the pandemic and design elements to our clinical trials to try to minimize the impact. There are unknowns, of course. But at this point in time, we're not seeing anything that has been unforeseen," Kinney said.
MORE THAN JUST ALZHEIMER'S: Prothena focuses on diseases that are caused by dysregulated proteins, which takes the company into two therapeutic indication spaces. "The first is known as peripheral amyloid diseases where proteins tend to accumulate in peripheral organs like the heart or the liver. And then you have the neuroscience diseases like Alzheimer's and Parkinson diseases," the executive explained. "We feel like we are a very well diversified company from our pipeline perspective. Our focus, our expertise is around understanding how proteins get dysregulated and contribute to diseases and how best to intervene in that problem."
"Meet the Company" is The Fly's recurring series of exclusive interviews with Executive Officers to offer a deeper look inside the company.