SLEIPNIR clinical trial platform to test 3 Parkinson’s drugs at once
Cure Parkinson's funds efforts aimed at reducing later treatment failures
Cure Parkinson’s is funding SLEIPNIR, a multiarm clinical trial platform that will simultaneously test up to three disease-modifying treatments for Parkinson’s disease — assessing whether any of them can engage with their intended targets in the brain.
The results are expected to help decide if these treatments should enter late-stage efficacy trials, according to a press release from the nonprofit. The hope, Cure Parkinson’s noted, is that SLEIPNIR will reduce the risk of drugs failing in larger-scale trials by testing several medications at once against the same placebo group in a smaller study with a shorter time frame.
Cure Parkinson’s has invested £1 million (approximately $1.35 million) to support the platform, which is set to enroll 120 participants later this year.
“SLEIPNIR represents an important step forward in how we evaluate potential disease-modifying therapies for Parkinson’s disease,” Charalampos Tzoulis, PhD, MD, professor at the University of Bergen and Haukeland University Hospital in Norway, said in a press release sent to Parkinson’s News Today. Tzoulis is the leader of the team that will conduct the trial.
“By assessing whether treatments engage their intended targets in the human brain, it aims to reduce early development risks and improve success in later trials,” Tzoulis said.
Trial seeks to ID drugs that can reach the brain
Parkinson’s disease is caused by the progressive loss of dopaminergic neurons, the nerve cells responsible for producing dopamine, which is a key signaling molecule involved in motor control. To date, there are no disease-modifying treatments that can slow, stop, or reverse disease progression, though a number of available medications can help manage Parkinson’s symptoms.
A big challenge in Parkinson’s research, the scientists noted, is determining whether treatments can effectively reach the brain and produce the desired effects there. Many late-stage clinical trials fail because only small amounts of the drug actually make it into the brain.
Per the scientists, this makes it essential to identify treatments early in development that can cross into the brain in sufficient quantities to reach their targets and have a higher chance of success.
Clinical trial platforms like SLEIPNIR are absolutely necessary for bringing the new potentially disease-modifying treatments to people living with Parkinson’s.
Tzoulis’ team will simultaneously assess the safety and tolerability of multiple therapies, and evaluate whether they can enter the brain and interact with their respective targets. This will be done by analyzing the medication’s levels in the blood and cerebrospinal fluid, which is the fluid that bathes the brain and spinal cord.
“Cure Parkinson’s is committed to accelerating the testing and development of therapies aimed at slowing the progression of Parkinson’s,” said Simon Stott, director of research at Cure Parkinson’s. “Clinical trial platforms like SLEIPNIR are absolutely necessary for bringing the new potentially disease-modifying treatments to people living with Parkinson’s, and we look forward to seeing how the project develops.”
Promising treatments from this study will then enter larger, late-stage clinical trial platforms to assess interim efficacy measures of whether a therapy is having a beneficial effect.
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