NRG Therapeutics announces a PET biodistribution trial of lead clinical asset NRG5051

NRG Therapeutics, an innovative clinical stage neuroscience company targeting a novel mechanism to restore mitochondrial dysfunction in neurodegenerative diseases, today announced a positron emission tomography (PET) imaging trial (NRG5051-102) to assess the biodistribution of its lead clinical asset NRG5051 has started. 

NRG5051 is an orally bioavailable and CNS-penetrant next-generation inhibitor of the mitochondrial permeability transition pore (mPTP) that acts through a novel NLRX1-mediated mechanism of action.

NRG has successfully radiolabelled NRG5051 to allow PET imaging and is now undertaking PET scans of healthy volunteer participants. The trial, being conducted in London (UK), aims to demonstrate CNS penetration and help to inform dose selection in future clinical trials in patients. Specifically, it will determine blood plasma kinetics and calculated distribution coefficient, which will allow NRG5051 levels in brain parenchyma to be estimated.

NRG Therapeutics’ CDO Paul Thompson said:

This PET trial is another important step in the development of our lead clinical stage asset NRG5051 and underlines our commitment to establishing the best possible understanding of the molecule. Data from PET biodistribution studies will complement and confirm NRG5051 CNS penetration estimates through other methods and contribute to the robust data set we are building to support clinical development in ALS and Parkinson’s.

NRG5051 is currently completing a Phase 1 randomized, double-blind clinical trial (NRG5051-101) to assess safety, tolerability and pharmacokinetic parameters in healthy volunteers. Future dosing in ALS patients, including a Phase 2 proof-of-concept trial in ALS patients is planned for 2027.