BioVie Presents Data for NE3107 at 2023 International Congress of Parkinson’s Disease and Movement Disorders - Seite 2

Safety and Pharmacokinetics of Anti-Inflammatory NE3107 Treatment in Carbidopa/Levodopa-Treated
Patients with Parkinson’s Disease: A Phase 2a, Double-Blind, Placebo-Controlled Study (Jason Aldred, Ramon Rodriguez, et al) – presented as a poster Monday, 28 August 2023 at 13:00 – 15:00 CEST

• The objectives of this clinical trial were to evaluate the safety, tolerability, and exploratory effects of anti-inflammatory NE3107 treatment adjunctive to concomitantly administered carbidopa/levodopa (C/L) in patients with PD and examine its effects on the pharmacokinetics (PK) of levodopa.
• Results showed that in comparison of Day 1 and Day 14 of treatment, PK parameters demonstrated that NE3107 administration did not affect the PK profile of levodopa:
  • In patients who received NE3107 + C/L, levodopa AUC was 4243.08 (±1913.81) ng·h/mL and 4127.41 (±1568.47) ng·h/mL on day 1 and day 14, respectively.
  • In patients who received placebo + C/L, levodopa AUC was 3175.55 (±2526.68) ng·h/mL and 3093.19 (±1919.73) ng·h/mL on day 1 and day 14, respectively.
  • PK analysis on day 14 showed that levodopa reached a maximum serum concentration (Cmax) of 2089.15 (±973.08) ng/mL and 3093.19 (±1919.73) ng/mL in patients treated with NE3107 + C/L and placebo + C/L, respectively.
• Investigators concluded that the findings of the NM201 study, together with the results of the marmoset pre-clinical study, suggest that through its anti-inflammatory and insulin-sensitizing properties, NE3107 may possess intrinsic pro-motoric and potentially levodopa-enhancing activities, while having a favorable safety profile, and support further investigation of the safety and clinical benefit of nondopaminergic therapies in late-phase clinical trials.

A Randomized, Phase 2a, Double-Blind, Placebo-Controlled Clinical Trial with NE3107 Adjunctive to Carbidopa/Levodopa in Patients with Parkinson’s Disease (Jason Aldred, Ramon Rodriguez, et al) -presented as a poster Monday, 28 August 2023 at 13:00 – 15:00 CEST

• This separate analysis of the Phase 2a trial examined the exploratory efficacy of NE3107, specifically improvement of motor function, in C/L-treated patients with PD.
• Clinical efficacy was assessed by evaluating changes in motor control as assessed by MDS-UPDRS scores, between visit 1 and visits 2, 5, and 6, and between visit 2 and visits 5 and 6.
• Results showed that on day 28, patients treated with NE3107 + C/L demonstrated a lower (3+ points) MDS-UPDRS Part III (motor) score than patients treated with placebo + C/L at the 2- and 3-hour marks, indicating improved motor control.
  • Patients who received NE3107 + C/L had a lower Part III disease score at time 0 (before medication administration) compared to patients treated with placebo + C/L
• On day 28, patients <70 years old treated with NE3107 + C/L experienced improvements that were ~6 points better than those who received placebo + C/L at the 2- and 3-hour marks
  • NE3107 +C/L-treated patients <70 years old had lower morning OFF state MDS-UPDRS Part III scores prior to medication administration (t=0) compared to those treated with placebo + C/L.
• 80% of NE3107 + C/L-treated patients and 88.9% of NE3107 + C/L-treated patients <70 years of age demonstrated >30% improvement in their MDS-UPDRS Part III scores 2 hours post administration from baseline, compared with 63.6% and 66.7% of all patients and patients <70 years of age, respectively, treated with placebo + C/L.
• Investigators concluded that the NE3107 + C/L combination treatment was associated with clinically meaningful and superior improvements (3+ points) on the motor examination part (Part III) of the MDS-UPDRS, and demonstrate the potential intrinsic and levodopa-enhancing, pro-motoric activity of NE3107 that is consistent with data from pre-clinical trials and support further clinical investigation of nondopaminergic therapies in late-phase clinical trials.

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