NE3107 added to levodopa enhances motor, non-motor benefits

46 Parkinson’s patients on stable CD/LD with off episodes enrolled in study

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by Andrea Lobo |

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Adding NE3107 to standard carbidopa/levodopa (CD/LD) therapy eases motor and non-motor symptoms in people with Parkinson’s disease, according to data from a Phase 2a trial.

“These data suggest that NE3107 as an adjunct therapy to levodopa may hold promise in ameliorating specific non-motor symptoms of Parkinson’s Disease, particularly in sleep/fatigue and restlessness of the legs,” Joseph Palumbo, MD, BioVie’s chief medical officer, said in a company press release.

The trial findings will be presented at the AD/PD 2024 International Conference on Alzheimer’s and Parkinson’s Diseases, set for this week in Lisbon, Portugal, and virtually. The oral presentation “Improvement of Non-Motor Symptoms with NE3107 Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease: A Phase 2A, Placebo-Controlled Study” will be on March 9.

Parkinson’s and other neurological conditions are marked by inflammation in the brain, called neuroinflammation, which can damage nerve cells and contribute to disease progression.

The diseases also commonly feature insulin resistance, when cells aren’t as able to use sugar for energy production, which may contribute to neurological problems.

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Adding NE3107 to levodopa

NE3107 is a small, orally available molecule designed to enter the brain and promote anti-inflammatory and insulin-sensitizing responses against neuroinflammation and energy-related issues. Originally developed by NeurMedix, its rights were acquired by BioVie in 2021.

The Phase 2a NM201 trial (NCT05083260) enrolled 46 patients who were on stable CD/LD and having early morning off episodes, or periods when their symptoms weren’t effectively controlled between treatment doses.

The participants were randomly assigned to an oral capsule of either 20 mg NE3107 or a placebo, twice daily for 28 days, on top of their CD/LD medication. Motor function was assessed in the morning on various days to see how treatment eased symptoms.

The trial showed NE3107 could be safely administered with levodopa and resulted in significantly greater motor function gains, as assessed by Part 3 of the Unified Parkinson’s Disease Rating Scale (UPDRS).

The final trial results showed the reduction in motor scores after treatment was more than 3 points higher in those given NE3107 plus CD/LD than in those on CD/LD alone. The difference was higher than 6 points for those under age 70.

Moreover, 26% of participants treated with NE3107 saw significantly better motor function in the morning, before taking the medication, which was equal to or better than after taking CD/LD at the study’s beginning. No patient taking a placebo reported such improvements.

The treatment also led to significantly less sleep and fatigue, measured by the Non-Motor Symptom Scale (NMSS), whereas those on a placebo saw their symptoms worsen. The improvements were significantly correlated with motor score improvement. NMSS changes with NE3107 were driven by less fatigue and more energy, as well as less restlessness in the legs.

“These findings extend previously reported improvement in motor symptoms with NE3107 and demonstrate potential intrinsic and levodopa-enhancing activity of NE3107 that is consistent with data from animal models and support further clinical investigation of NE3107 in late-phase trials,” Palumbo said.

NE3107 is also being developed for Alzheimer’s disease, the most common cause of dementia, and a Phase 3 trial is showing promising cognitive and functional data.

“These findings add to the growing body of evidence supporting our hypothesis that by selectively modulating inflammation and enhancing insulin sensitivity in the brain, NE3107 could offer benefits in slowing disease progression and improving the lives of patients living with these devastating conditions,” Cuong Do, BioVie’s president and CEO, said.