Additional preliminary findings from its Parksinson’s Disease (PD) phase 2 trial show that significantly more patients treated with Biovie’s NE3107 small molecule drug were assessed as being in an ‘on state’ in the morning after withholding their usual standard of care (SOC) for at least eight hours before taking their usual morning Parkinson’s medications, compare to patients on SOC alone plus placebo.
The company has found that many PD patients complain of having rigid muscles and difficulties getting out of bed in the morning, which is referred to as the muscles being in an “off state.”
It said patients are in the “on state” if they retain sufficient muscle control. The “on state” is clinically meaningful for PD patients because it is the time when their motor symptoms are most optimally controlled, allowing for better movement and stability.
Anthony Lang is the Jack Clark Chair for PD research at the University of Toronto and was not involved in the trial but he has published more than 950 peer-reviewed papers and more than 100 book chapters. He is one of the most highly cited investigators in the field of movement disorders.
He said: “Biovie's phase 2 data is encouraging. Morning “off” symptoms cause significant impairment of movement and disability for patients with Parkinson’s Disease. A potential treatment that can address this symptom is an important therapeutic need.”
The Company previously reported that patients treated with the combination of NE3107, and levodopa experienced a 3+ points improvement on the part 3 (motor) score on the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (UPDRS), compared to patients treated with levodopa-alone. This difference is clinically meaningful according to PD experts. The difference is 6+ points among patients younger than 70 years old who presumably have less disease progression.
Before the study began and at several points throughout the 28-day trial, patients who did not receive PD medications for at least eight hours overnight were observed using 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.
Additional per protocol analysis of the preliminary data revealed that 6 out of 20 of the NE3107-treated patients compared to none of the placebo-treated patients experienced a morning “on state” with levodopa withheld overnight and prior to receiving their morning medication.
This, Biovie said, is explained by and can be seen most visibly from the right panel of the chart showing that NE3107-treated patients had lower part 3 (motor) disease score at time 0 (before medication administration) compared to those treated with levodopa alone. The company said these exploratory findings in human subjects are consistent with earlier findings from non-human primates, which demonstrated the intrinsic promotoric activity of NE3107.
“This trial was primarily a safety and drug-drug interaction study that we expanded in hopes of finding an efficacy signal,” explained Cuong Do, BioVie’s President and CEO.
“We believe that the data provide a very encouraging efficacy signal as measured by on/off state, and speak to the therapeutic potential we believe NE3107 may have for the treatment of PD.”
Based on the favorable results from the phase 2 trial, the company is currently preparing to launch the phase 3 potential pivotal trials to continue developing NE3107 in Parkinson’s Disease. The company expects to disclose additional details in the near future.