Parkinson’s therapy mirivadelgat selected for multi-drug clinical trial
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Foresee Pharmaceuticals' investigational drug mirivadelgat (FP-045) has been selected for the Phase 2a SLEIPNIR platform trial. By activating the ALDH2 enzyme to break down toxic aldehydes, it aims to slow the progression of Parkinson's disease.
Phase 2a SLEIPNIR platform trial to assess safety, tolerability, brain penetration.Mirivadelgat, an oral therapy for Parkinson's, activates ALDH2 to break down toxic waste products, aiming to slow disease progression.It's entering a Phase 2a trial (SLEIPNIR) to assess safety, brain penetration, and target engagement in Parkinson's patients.This platform trial evaluates multiple drugs simultaneously to accelerate promising treatment identification.
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.
Accelerating Parkinson's Research
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.”
Mechanism of Action: ALDH2 Activation
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.
