BioVie Inc. announced details of three presentations given from studies of NE3107 in the treatment of Parkinson?s Disease (PD) at the 2023 International Congress of Parkinson?s Disease and Movement Disorders (MDS), being held in Copenhagen, Denmark August 27-31, 2023. Details of the three presentations are as follows: Effects of NE3107 Anti-Inflammatory Treatment on Motor Activity and Neurodegenerative Features of Parkinson?s Disease in a Marmoset Monkey Model (Ingrid H.C.H.M. Philoippens, Clarence Ahlem, Christopher L Reading) ? presented as a poster and oral presentation on 30 August 202313:00 CEST.

Objectives of this pre-clinical study were to evaluate the safety, tolerability, and the extent of anti-inflammatory effects of NE3107 treatment, specifically on the major features of PD in marmosets with Parkinson?s-like disease. Results showed that mean immobility scores with NE3107 monotherapy (during weeks 8 and 9 on therapy) were significantly lower, indicating improved mobility, than comparison treatment with amantadine HCl or vehicle only. These improvements within 24 hours of initiating NE3107 monotherapy, suggesting a direct influence on neuro-motor signaling, as opposed to an effect that increased with time of treatment, which might imply a link to neuroprotection.

Investigators concluded that the findings corroborate the involvement of chronic neuroinflammation and insulin resistance in PD clinical symptoms, in addition to neurodegenerative pathways, support the continued investigation of therapies like NE3107 nondopaminergic therapies. 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 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 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.