ANVS401 Shows Promise in Alzheimer Disease, FDA Approves IND for Ketamine in Parkinson, MedRhythms Collaborates With Massachusetts General Hospital

This week Neurology News Network covered the positive phase 2a trial of ANVS401 in patients with Alzheimer disease, the investigational new drug application for ketamine in patients with Parkinson disease, and the collaborative study between MedRhythms and Massachusetts General Hospital.

Welcome to this special edition of Neurology News Network. I’m Marco Meglio. Please excuse our appearance this week as a majority of the US workforce, including the NeurologyLive team, moves to working remote as we come together to help reduce the spread of the novel coronavirus.

Newly published interim results from an ongoing phase 2a clinical trial (NCT04524351) demonstrated that treatment with ANVS401 (Annovis Bio) is associated with statistically significant improvement in cognition as measured by the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11. Thus far, 14 patients with Parkinson disease (PD) and 14 patients with Alzheimer disease (AD) have been treated and have completed biomarker analysis. The remaining 40 patients are currently being treated with different doses to determine the optimal dose. Patients treated with ANVS401 for 25 days showed a statistically significant 4.4-point improvement (30%) on the ADAS-Cog11, and when compared with placebo, investigators recorded a 3.3 point (22%) improvement on the ADAS-Cog11. Notably, this is the first double-blind, placebo-controlled study to demonstrate cognitive improvements in patients with AD using ADAS-Cog11 and functional improvements in patients with PD as measured by the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale

The FDA recently approved PharmaTher Holdings’ investigational new drug application for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson disease (PD), with a phase 2 clinical trial on the way. The phase 2 trial will evaluate the safety, efficacy, and pharmacokinetics of ketamine in this population and is expected to begin patient enrollment in the third quarterof 2021. PharmaTher also noted that pending the success of the trial, the company will seek an agreement with the FDA to move to a phase 3 clinical study under the 505(b)(2) regulatory pathway next year. PharmaTher intends to enroll a target number of 36 individuals randomized to either ketamine or midazolam (Nayzilam; UCB), the active control, in the phase 2 clinical trial. Investigators will use change in the Unified Dyskinesia Rating Scale (UDysRS) total score from baseline to week 8 as the primary end point.

According to a recent announcement, digital therapeutics company MedRhythms is collaborating with Massachusetts General Hospital (MGH) on a neuroimaging study that will assess MR-004, MedRhythms’ multiple sclerosis asset. Funded by the National Multiple Sclerosis Society, the groundbreaking trial will be the first neuroimaging study to examine the impact that rhythmic auditory stimulation (RAS) has on walking impairments in patients with MS. MR-004, a digital therapeutic that uses rhythmic sounds, will be evaluated in a randomized crossover trial that will assess outcomes including gait speed and neuroimaging compared to the standard of care. The study expands on a pilot study that is assessing the safety and efficacy of MR-004 in patients with MS at Cleveland Clinic, which was announced in January 2020.2 Made possible by a grant from the Consortium of Multiple Sclerosis Centers (CMSC), that study is led by MedRhythms MS Scientific Advisory Board (SAB) member Francois Bethoux, MD

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