Parkinson’s therapy mirivadelgat selected for multi-drug clinical trial

Foresee Pharmaceuticals’ oral therapy mirivadelgat has been selected to enter the Phase 2a SLEIPNIR platform trial, which is testing several experimental treatments for Parkinson’s disease.

The trial, funded by Cure Parkinson’s and conducted in collaboration with Haukeland University Hospital in Bergen, Norway, is evaluating multiple therapeutic candidates in parallel, using a shared placebo group and common infrastructure. It is designed to assess treatments’ safety and tolerability, and their ability to enter the brain and interact with intended targets.

By assessing multiple drugs simultaneously in a shorter, smaller trial, SLEIPNIR aims to accelerate the identification of promising treatments that can then be included in larger, late-stage clinical trial platforms.  This is expected to reduce the risk of larger clinical trials failing.

“This is a significant opportunity to provide further validation of mirivadelgat/ALDH2 activation as a potential treatment approach for Parkinson’s, and potentially other CNS diseases,” Ben Chien, Foresee’s CEO, said in a company press release. “We are grateful to the SLEIPNIR team, potential participants in the study and Cure Parkinson’s for their support.”

Charalampos Tzoulis, MD, PhD, the trial’s lead investigator and professor at Haukeland University Hospital and the University of Bergen, said the treatment was chosen “through a highly competitive and scientifically rigorous process.”

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Small molecule activates enzyme to break down waste products

Parkinson’s disease is caused by the progressive loss of nerve cells that produce dopamine, a signaling molecule involved in motor control. Though several medications can help manage Parkinson’s symptoms, there are no disease-modifying treatments that can slow or stop disease progression.

Mirivadelgat (FP-045) is an investigational small molecule designed to activate aldehyde dehydrogenase 2 (ALDH2), an enzyme located in the mitochondria (cellular structures crucial for energy production) that breaks down toxic waste products called aldehydes. In Parkinson’s, impaired ALDH2 activity leads to the toxic accumulation of aldehydes, which accelerates nerve cell damage and worsens disease symptoms.

“The role of ALDH2 in the [mechanisms of Parkinson’s disease] and other neurological diseases is quite compelling when looking at the current body of data,” said Wenjin Yang, PhD, Foresee’s chief scientific officer. “We are confident the results from this study will provide a strong foundation for further development in [Parkinson’s] and other CNS [central nervous system] diseases as this study will provide data related to CNS penetration and target/biomarker engagement of mirivadelgat”.

Rather than testing each treatment in a separate, early-stage study, SLEIPNIR evaluates several investigational therapies, allowing more efficient assessment of brain penetration, target engagement, and mechanistic biomarker effects.

The mirivadelgat group will enroll 40 Parkinson’s patients, who will be randomly assigned to receive the treatment (30 participants) or a matching placebo (10 participants) once daily for three months, in addition to standard treatments. This will be followed by an additional two weeks of safety follow-up.

The trial will assess whether the drug interacts with its intended target in the brain by analyzing the blood and cerebrospinal fluid ( the fluid that surrounds the brain and spinal cord). It will also monitor the treatment’s safety and tolerability.