BioVie Announces Positive Results for NE3107 in Parkinson’s and Alzheimer’s Phase 2 Trials - Seite 2

“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,” commented Joseph Palumbo, BioVie’s Chief Medical Officer. “The NE3107-levodopa combination’s ability to provide 3+ points improvement on the part 3 score compared to levodopa-alone is a very meaningful clinical benefit according to PD experts. It may be more beneficial for patients whose disease is less advanced as seen from the 6+ point superiority on the part 3 score for patients <70 years old.”

Before study commencement and at multiple points throughout the 28-day trial, patients who did not receive PD medications for at least 8 hours overnight were observed using the Unified Parkinson’s Disease Rating Scale (UPDRS) first thing in morning (hour 0). Patients were then given medication and observed again using UPDRS at 1, 2, 3, 4, and 8 hours after drug administration. Part 3 of the UPDRS instrument assessed motor control.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9df20fac-a2d3-4f6b ...

• Patients treated with NE3107 and levodopa saw improvements of part 3 score on Day 28 compared to Day 0 that is 3+ points better than those treated with levodopa alone at the 2- and 3-hour marks. This level of superiority is considered by PD experts to be clinically meaningful.¹
• Patients younger than 70 years old treated with NE3107 and levodopa experienced improvements that are roughly 6 points better than levodopa-treated alone. Patients younger than 70 years old represented roughly one-half of study participants.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7ace7875-4e88-4f98 ...

• After 28 days of treatment, 63.6% of patients treated with levodopa alone experienced >30% improvement from Day 0 at the two-hour mark compared to 80% for NE3107+levodopa-treated patients and 88.9% of NE3107+levodopa patients under 70 years old. This pattern is also observed for other time periods.
• There were no drug-related adverse events

Full details from this trial will be presented at the upcoming AD/PD 2023 International Conference on Alzheimer’s and Parkinson’s Diseases to be held March 28-April 1, 2023 in Gothenburg, Sweden.