NE3107 Plus Levodopa Leads to Better Motor Gains: Phase 2 Trial
Meaningful benefits seen in Parkinson's patients with off periods
BioVie’s investigational oral therapy NE3107, taken in combination with standard levodopa, eases motor symptoms more substantially than levodopa alone in people with Parkinson’s disease, according to top-line results of a Phase 2 clinical trial.
“NE3107 shows promise, and if the current findings are confirmed, it may represent one of the most significant advances in Parkinson’s treatment in decades,” Joseph Palumbo, MD, BioVie’s chief medical officer, said in a company press release.
“This trial is primarily a safety and drug-drug interaction study that we expanded in hopes of finding an efficacy signal,” said Cuong Do, company president and CEO.
“The fact that this small trial showed this magnitude of therapeutic impact for NE3107 allows us to proceed with planning the Phase 3 program for discussion with the FDA [U.S. Food and Drug Administration],” Do added.
Next step for NE3107 may be a Phase 3 trial in Parkinson’s patients
Full trial findings will be presented at the AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases, to be held March 28–April 1 in Gothenburg, Sweden.
Neuroinflammation, insulin resistance, and oxidative stress, a type of cellular damage, are common features of several neurodegenerative diseases, including Parkinson’s and Alzheimer’s disease.
Originally developed by NeurMedix and acquired by BioVie in 2021, NE3107 is a small molecule that’s able to enter into the brain with a goal of exerting anti-inflammatory and insulin-sensitizing effects.
The Phase 2 trial, called NM201 (NCT05083260), enrolled 45 adults with Parkinson’s who were on stable levodopa/carbidopa treatment and experiencing early morning “off” episodes, or times when symptoms are not effectively controlled between doses.
Participants were randomly assigned to take an oral capsule of either 20 mg of NE3107 or a placebo, in addition to their levodopa/carbidopa dose, twice daily for 28 days.
The study had two main goals: to show that NE3107 could be safely co-administered with levodopa, and to assess whether adding the experimental treatment resulted in greater gains in motor function. Both goals were met.
On various days throughout the trial, participants underwent a motor function assessment first thing in the morning, before treatment. They then would take their medications and be assessed several times over the course of the next few hours to see how treatment eased symptoms.
Motor symptoms were assessed using part 3 of the Unified Parkinson’s Disease Rating Scale (UPDRS), in which higher scores indicate worse motor function.
End-of-study results showed that the reduction in UPDRS motor scores at two and three hours post-treatment was three points greater in patients given NE3107 plus levodopa than in those given levodopa alone. That “is a very meaningful clinical benefit,” Palumbo said.
This group difference was even more pronounced among patients younger than 70 — reported to account for about half of all trial participants — with the experimental therapy associated with a six-point-greater score drop.
NE3107 “may be more beneficial for patients whose disease is less advanced as seen from the [six] point superiority on the part 3 score for patients [less than] 70 years old,” Palumbo said.
A greater proportion of NE3107-treated patients (80%) also showed a motor score reduction of at least 30% at two hours post-treatment, compared with those on a placebo (63.6%).
Again, this difference was even more pronounced for NE3107-treated patients under age 70, with nearly 9 in 10 (88.9%) showing such improvement.
There were no reports of adverse events related to the experimental therapy, according to BioVie.
“My review of the BioVie study of NE3107 in Parkinson’s Disease suggests that there is a probable signal of clinical efficacy in the treatment of motor symptoms. This signal should be pursued in a larger, focused, confirmatory study,” said Douglas Felter, MD, PhD. A former pharma executive experienced in Parkinson’s drug development and now working as a consultant, Felter was not directly involved in the trial.
NE3107 is also being developed as a potential therapy for Alzheimer’s, the most common cause of dementia. In its release, BioVie also reported findings in a small, open-label Phase 2 trial that indicated the therapy led to improvements in cognitive tests and reductions in disease biomarkers among Alzheimer’s patients.
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