Bayer Launches Investigator-Sponsored Collaborative Studies

By Dan Schell, Chief Editor, Clinical Leader

Listen, if you’re going to name your clinical development program MOONRAKER — in all caps — you’re going to get noticed, especially from people like me who know that word only as the title of a 1979 James Bond movie. And that’s what led me to talking with Robert Perkins, MD, VP, Cardiovascular & Renal at Bayer. Although he didn’t know the origins of the unique name (chosen by a clinical development arm of Bayer in Germany), he did add to the intrigue by explaining there is also a separate program focused on chronic kidney disease called THUNDERBALL — another Bond film.

But the Bond-influenced naming convention stopped there; MOONRAKER’S four studies are called FINEARTS-HF, REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF. The latter three were announced in late August as additions to the program, which started in 2020 with the Phase 3 FINEARTS-HF trial that, so far, has enrolled a little over 6,000 patients and is focused on the study of Kerendia (finerenone) as a potential treatment for heart failure. The company plans to enroll an additional 9,000 patients through the three new trials, which are funded by Bayer but sponsored by CPC Clinical Research, a non-profit academic research organization (ARO) affiliated with University of Colorado, which is conducting the studies in collaboration with other AROs around the world.

Perkins explains that FINEARTS-HF is a Bayer-initiated, Bayer-sponsored Phase 3 trial. The other three trials are investigator-sponsored collaborative studies. “There are different ways to do these kinds of trials. First, there is the traditional investigator-initiated trial, which is often a grant that a pharma company will extend to an academic institution or investigator to do some body of work that’s of mutual interest. In this example, it’s a very hands-off relationship; there’s no kind of interaction other than maybe a report every year or six months — something like that. And then ultimately, hopefully [the findings get published]. These new trials are different. These are more collaborative, meaning that there is an established rhythm of interactions and co-creation of trials, trial design, objectives, endpoints, etc. All the details of a typical trial would be discussed through the steering committee, of which we have separate ones for each of these trials.”

Perkins was one of the first people in Bayer’s medical affairs department to work on MOONRAKER back in its early days when it was being developed. He left the company in 2019 but returned this past March, albeit to a much more advanced MOONRAKER, including the additional three new trials. He says those new trials will attempt to answer fundamental day-to-day, in-the-hospital, in-the-clinic practical questions about how to manage patients with acute decompensated heart failure. For example, clinicians will want to know how and when to use Kerendia and how it works in combination with other drugs.  “I came back to Bayer because I think this is a wonderful program, but if there’s anything that keeps me up at night, it’s the totality of these programs,” says Perkins. “It’s the trials. It’s getting them done. All of it. We have some really big programs right now, not just in heart failure, but for other conditions such as type 1 diabetes, non-diabetic chronic kidney disease, and pediatric kidney disease. I joke with folks that with MOONRAKER, I got to avoid all the hard work in the middle because I wasn’t here. But, there’s still a lot to do; it’s exciting every day.”

The following are some details on the three new MOONRAKER Phase 3 trials:

1. REDEFINE-HF
   1. Estimated start date: 11-2023
   2. Estimated end date: 4-2026
   3. Estimated enrollment: 5,200
2. CONFIRMATION-HF
   1. Estimated start date: 2-2024
   2. Estimated end date: 8-2025
   3. Estimated enrollment: 1,500
3. FINALITY-HF
   1. Estimated start date: 6-2024
   2. Estimated end date: 11-2027
   3. Estimated enrollment: 2,600