Shake It Up Supporting New Trial of Anavex 2-73 in Parkinson’s Patients

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by David Melamed, PhD |

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The Shake It Up Australia Foundation for Parkinson’s Research, together with its partners worldwide, has pledged to cover up to 50% of the costs associated with opening a clinical trial into oral Anavex 2-73 (blarcamesine) as a treatment for Parkinson’s disease.

Anavex Life Sciences, the developer of Anavex 2-73, announced that it will evaluate the treatment’s safety, tolerability, and efficacy in a planned study that will last at least 48 weeks, with a voluntary open-label (no placebo group) extension for participants interested in continuing treatment.

Patients enrolled in the planned trial will be given either the oral treatment once daily or a matching placebo.

Anavex 2-73, originally developed as a potential disease-modifying therapy for Alzheimer’s disease, is a small molecule that can target and activate the sigma-1 receptor (S1R) protein, which is responsible for regulating cellular activity and maintaining the natural balance of brain cells.

Activating the S1R protein, which is found at lower-than-usual levels in the brains of Parkinson’s and Alzheimer’s patients, can help reduce neuroinflammation, as well as lessen the accumulation of beta-amyloid and tau proteins and oxidative stress, all known to contribute to progression in neurodegenerative disorders.

In preclinical studies using an animal model of Parkinson’s disease, Anavex reports that Anavex 2-73 significantly improved motor function recovery and lowered the activation of microglial cells, thought to be a biomarker of Parkinson’s, in animal models.

Of note, microglial cells are cells present in the central nervous system (brain and spinal cord) that mediate immune responses by clearing cellular debris and dead neurons from nervous tissue.

Those results paved the way for Anavex to study the treatment in patients with Parkinson’s disease.

“Shake It Up is proud and excited to support research like this that may create opportunities for breakthroughs that could be a game-changer for people with Parkinson’s,” Clyde Campbell, founder and CEO of the Shake It Up Foundation, said in a press release. “The potential of a disease modifying treatment for Parkinson’s disease could be a very promising next step in further human testing of Anavex 2-73, in which the therapy goes through a rigorous process to determine whether it is safe, tolerable and efficacious.”

A randomized and double-blind Phase 2 trial, called ANAVEX2-73-PDD-001 (2017-004335-36), is underway in Spain to investigate Anavex 2-73 in people with dementia caused by Parkinson’s disease.

This ongoing trial, which was recently reported to be fully enrolled, is comparing the effects of Anavex 2-73 at two different doses with a placebo over the course of 14 weeks.

Based on a previous Phase 2a clinical (NCT02244541) trial in Alzheimer’s patients, Anavex has also developed specific biomarkers to detect the presence and activity of Anavex 2-73. These biomarkers are expected to be used in the planned Parkinson’s trial.

By partnering with Shake It Up, Anavex is aiming to speed the development of Anavex 2-73, both in general and specifically as a potential Parkinson’s treatment.

“We see this collaboration as an important step in our global effort to expedite the development of Anavex 2-73 and to evaluate Anavex 2-73 for Parkinson’s disease as a potential disease modifying agent,” said Christopher Missling, PhD, president and CEO of Anavex.

“Shake It Up Foundation shares our commitment to move rapidly to address the unmet need for treatments for Parkinson’s disease, and brings deep experience and an extensive network within the Parkinson’s community,” Missling added.