NeuroDerm has announced positive phase 3 results for its investigational ND0612 in Parkinson’s disease (PD) patients living with motor fluctuations.
The BouNDless trial, published in the Lancet Neurology, evaluated the efficacy, safety and tolerability of ND0612 in 381 PD patients aged 30 years or older.
Affecting around ten million people worldwide, PD is a progressive neurodegenerative disease that affects the brain, causing symptoms such as shaking and stiffness.
ND0612 is a continuous, 24-hour-a-day subcutaneous infusion of liquid levodopa/carbidopa (LC/CD).
“Orally administered LC/CD tablets remain the most essential pharmacological intervention in PD; however, over time the reliability of its benefits can decrease, leading to the onset of motor fluctuations,” said professor Alberto Espay, principal US investigator of the trial.
Caused by a positive or therapeutic response to dopaminergic therapy and a declining or absent response to dopaminergic therapy, motor fluctuations are alterations in movement function.
More than 60% of PD patients will experience motor functions after five to ten years of treatment.
Results from the BouNDless trial demonstrated that ND0612 met its primary endpoint and the first four secondary endpoints, which showed that it was superior to oral immediate-release LD/CD at increasing ‘on’ time in patients without causing dyskinesia and reducing ‘off’ time, after 12 weeks.
In addition, the systemic safety profile of ND0612 was consistent with the safety profile of oral standard of care (LD/CD).
“We are encouraged by this positive data, which we believe supports ND0612, if approved, as a potential treatment option for people with PD experiencing motor fluctuations who have thus far had limited options,” added Espay.
Tami Yardeni, executive vice president, clinical development, NeuroDerm, commented: “These results show significant improvement of motor fluctuations as well as improvements in the experiences of daily living for this challenging patient population.”
The safety and efficacy of investigational ND0612 in PD is currently under review by the US Food and Drug Administration, which previously assigned a prescription drug user fee act target action date for the second quarter of 2024.