Development of a novel FGL therapy and translational tests for regenerative treatment of neurological disorders

Neurodegenerative disorders such as, Alzheimer’s disease (AD), Mild Cognitive Impairment (MCI), stroke, Traumatic Brain Injury (TBI) and chronic stress create a major economic burden to society and a substantial reduction in quality of life for patients and families. The development of neuroregenerative therapies is notoriously difficult and requires significant investment.

NeuroFGL will contribute to decrease these barriers through:

(1) the clinical advancement of a promising novel regenerative therapy (FGLs) for neurological disorders,

(2) hedging the clinical development by developing tests that enable early clinical assessments to be made, thereby maximising the chance that FGL and other neurogenerative therapies actually become developed to the benefit of patients and society; and

(3) Selecting a target patient population with less variability and thereby easier to study – reducing and time resources needed, and increase predictability .

FGLs is a promising and novel regenerative therapy being the clinical lead development candidate selected from a group of allosteric FGF-receptor modulators (referred to as FGL) mimicking NCAM. FGL has demonstrated positive effects in a number of in vivo models of neurodegeneration, e.g. beta-amyloid induced toxicity, global ischemia and chronic stress. The in vivo effects of FGL suggest a disease-modifying activity in several neurodegenerative disorders, such as neurogenesis.

A phase I clinical study has demonstrated a FGL peptide to be well tolerated and safe. NeuroFGL will refine existing and develop new tests and techniques, that will at an early stage of the clinical development: (1) provide better information on the mechanisms of action (NCAM mimicking allosteric FGF recoter modulation) in man, (2) deliver translational effects seen between animal and man, (3) provide results earlier and cheaper, increasing the iteratiation and (4) select patients with conditions associated with less variability, e.g. patients with AD with a specific EEG or patients progressing to AD identified in patients with MCI. These developments will together provide a more robust basis for the development of FGLs, other drugs with a similar mechanism of action and other therapies for neurodegenerative disorders.