Swedish company IRLAB Therapeutics is looking to dose the first patient in a Phase IIb trial of its pipeline candidate pirepemat in Parkinson’s disease patients.
IRLAB CEO Gunnar Olsson told Clinical Trials Arena that the company is aiming to dose the first patient in the REACT trial by the end of the year, with enrolment predicted by the end of Q3 2024.
REACT will be a randomised, placebo-controlled trial evaluating the candidate in fall frequency in advanced patients.
The trial will enrol patients from France, Germany Netherlands, Spain, Sweden, and Poland. There will be three arms to the study, specifically two treatment arms to determine the dosing and a placebo arm.
The primary endpoint will be fall frequency while other endpoints will investigate apathy, other aspects of balance and neuropsychiatric symptoms such as cognitive impairment.
Pirepemat is the second most advanced candidate in IRLAB’s drug pipeline and acts by inhibiting the alpha 2 and serotonin 7 receptors.
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By GlobalData
The company will present the trial at the 18th International Conference on Alzheimer’s and Parkinson’s Disease and related neurological disorders in Lisbon, Portugal, on 8 and 9 March.
IRLAB’s pipeline of products
IRLAB is working on five pipeline products in Parkinson’s which are each targeting different unmet needs.
One of the pipeline candidates mesdopetam has just been assessed in a Phase II trial and Olsson said the company hopes to initiate a Phase III trial by the end of the year.
IRLAB completed an end-of-Phase II meeting with the US Food and Drug Administration (FDA) in February 2024, discussing its plans for the Phase III trial, including the primary and secondary endpoints, key inclusion and exclusion criteria and safety monitoring during the study period.
Mesdopetam (IRL790), is a dopamine D3 receptor antagonist, in development for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs) which occurs in around 25% to 40% of patients.
Other pipeline products include IRL1117, a preclinical candidate which could be an alternative to levodopa without the complications; IRL757, a preclinical candidate which is expected to treat apathy and IRL942, a preclinical candidate which is aimed to treat impaired cognitive function.
Parkinson’s landscape
The Parkinson’s disease market is set to grow to $6.4bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by 2029, according to GlobalData analysis.
Several unmet needs remain and the main drivers in the market are expected to be key pipeline products, including Annovis Bio’s Buntanetap, BioVie’s NE-3107, Neuraly’s NLY01, and Roche/Prothena’s prasinezumab, which are being investigated for their disease-modifying or neuroprotective properties.
Other drivers are predicted to be novel delivery approaches for levodopa, such as those of AbbVie’s Produodopa/Vyalev, NeuroDerm’s ND0612, Amneal’s IPX203, Accorda’s Inbrija, and PureIMS’s Levodopa Cyclops.
GlobalData is the parent company of the Clinical Trials Arena.
This was shown first on: https://www.clinicaltrialsarena.com/news/irlab-dosing-pirepematparkinsons-disease-trial/
