Anavex Life Sciences Corp (AVXL)

[wildcard235]

MM-201, MJF Foundation preclinical document, excerpt and source:

Details of MJFF Grant

The goal of this project was to determine the clinical potential of a novel orally active hepatocyte growth factor (HGF) mimetic (MM-201) as a treatment of Parkinson’s Disease. The rationale guiding this project was: 1) the observation by others that an HGF plasmid injected directly into the substantia nigra (SN) resulted in localized over-expression of HGF, and acted dramatically to prevent neuronal cell death and preserve normal motor function in the 6-hydroxydopamine (6-OHDA) PD model; 2) the development of the first orally active, blood-brain barrier permeable HGF mimetic; and 3) the demonstration that the MM-201 lead compound was neuroprotective, able to stimulate synaptogenesis in vitro, and could reverse cognitive deficits in both acute (scopolamine) and chronic (aged rats) dementia.

Studies were conducted to demonstrate that peripherally delivered MM-201, both intraperitoneal (ip.) and oral, could reverse motor deficits in a 6-OHDA Parkinson’s model and begin to elucidate the underlying in vivo mechanism of action.

Results and Potential Next Steps

The primary outcome of this project was the demonstration that both ip. and oral administration of MM-201 was able to completely restore motor function in a 6-OHDA PD model. The recovery of function was observed within six days after the onset of treatment and was sustained for 34 days, at which point the studies were terminated. Coincident with functional recovery was a dramatic restoration of tyrosine hydroxylase staining in the lesioned SN. Concomitant studies also demonstrated that MM-201 stimulated striatal synaptogenesis and neurogenesis in the hippocampus and midbrain.

The next steps, which are either required for or would facilitate the clinical development of MM-201 for the treatment of PD, include IND-enabling studies, demonstration of target engagement in on-human primates using PET imaging and an 18F-MM-201 analog; and the identification of MM-201 activity-dependent biomarkers in non-human primates for use in early stage imaging clinical trials.

Source: https://www.michaeljfox.org/files/accelerate/participants/FINAL_MJFFPartneringProgram-M3BiotechnologyInc.pdf

* I do not find a date in the document but statements in Next Steps refer to the need for additional studies before before any clinical trials.
* It appears to me that Anavex has a multi-year advantage in clinical trials.
* It appears to me from other sources that M3 Biotechnology is currently privately held.