One year of ND0612 reduced off time, increased good on time
Studies compared treatment with immediate-release oral levodopa/carbidopa
Note: This story was updated Oct. 7, 2024, to correct references to the open-label extension study of the BounDNless trial.
A year of treatment with ND0612, an investigational liquid formulation of levodopa/carbidopa continuously administered as an infusion under the skin, sustainably reduced the periods of time when motor symptoms aren’t well controlled and improved the quality of life in people with advanced Parkinson’s disease.
That’s according to data from the BouNDless study (NCT04006210) and its ongoing open-label extension that compared the effectiveness of ND0612 with immediate-release oral levodopa/carbidopa in advanced Parkinson’s.
The data was presented in three posters at the 2024 International Congress of Parkinson’s Disease and Movement Disorders (MDS), which was held Sept. 27 to Oct.1 in Philadelphia and online. The trial was sponsored by the therapy’s developer Neuroderm, a subsidiary of Mitsubishi Tanabe Pharma Corp. (MTPC).
“The longer-term data presented at MDS provide insights into the potential of ND0612 to not only improve symptoms, but also maintain its efficacy, which may provide patients with a meaningful reduction in symptom burden,” Gustavo A. Suarez Zambrano, MD, MTP America’s vice president of medical affairs, said in a company press release. MTP America is a wholly owned subsidiary of MTPC.
In Parkinson’s, the progressive loss of dopaminergic neurons, the nerve cells that produce the chemical messenger dopamine, results in most disease symptoms. The combination of levodopa with carbidopa, which provides neurons with a molecule they can use to produce dopamine, is a mainstay treatment to ease motor symptoms.
Its long-term use can lead to uncontrolled, involuntary movement, called dyskinesia, and patients may have off episodes, periods between doses where symptoms aren’t well controlled. By delivering continuous amounts of levodopa/carbidopa throughout the day using an under-the-skin pump, ND0612 should minimize side effects and the off-time associated with long-term levodopa.
Previous results from BouNDless, where ND0612’s safety and efficacy were assessed for about three months, showed it extended daily on time, which are periods when symptoms are fully controlled, and reduced off time, compared to oral levodopa/carbidopa.
Gains in motor signs, quality of life with ND0612
New data presented at the meeting further showed the treatment eased Parkinson’s motor signs and improved motor experiences of daily living, as measured by the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
Patients receiving ND0612 demonstrated gains in several areas, such as speech, oral health, tremor, and self-care that were observed at both eight and 12 weeks. There was no significant difference between the treatments in rigidity and bradykinesia, or slow movement.
ND0612 also improved patients’ quality of life, as measured by the Parkinson’s Disease Questionnaire (PDQ)-39. The impact of ND0612 was observed in most domains, including mobility, bodily discomfort, cognition, social support, stigma, communication, and emotional well-being.
The therapy was generally well tolerated and the most common treatment-emergent side effects were infusion site reactions, and side effects similar to the oral medication, such as dyskinesia, motor fluctuations, and falls.
After completing the double-blind double-dummy phase of the BouNDless study, patients were able to enter the open-label extension phase. Data from the open-label extension showed patients had an off time average reduction of 2.2 hours after six months and 2.02 hours after a year, and an increase in on time without troublesome dyskinesia by 2.4 hours after six months and 2.11 hours after a year.
“These findings reinforce our commitment to studying ND0612, if approved, as a potential new treatment option for people with Parkinson’s disease experiencing motor fluctuations,” Zambrano said.
The U.S. Food and Drug Administration is reviewing ND0612’s safety and efficacy for a possible approval.
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