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Copenhagen, Denmark, May 18 2005 – Today ENKAM Pharmaceuticals A/S announces the completion of the first phase I clinical study for the synthetic peptide FGLL, which proved to be well tolerated and safe. In the study, 24 healthy males received FGLL by intranasal administration at one of the three dose ranges.
Throughout a broad range of models, including one Alzheimer Model, FGLL showed both neuroprotection and improvement of the memory and learning capability, which gives promise for FGLL to effectively treat Alzheimer’s disease. Furthermore, FGLL also demonstrated enhancement of memory and learning capability in normal animals.
“The effect of the molecule is unique by making the nerve cells much more vital and improving their communication. We therefore expect that FGLL can positively affect the ability of patients to learn and remember,” says cofounder and professor Elisabeth Bock, MD.
Following the successful completion of this study with FGLL, ENKAM now plans to progress the development of FGLL into phase II. To accelerate the development of FGLL through phase II and to the market ENKAM is actively pursuing a partnership.
“If we can achieve the same results in humans that we registered in the pharmacological studies this is a treatment with blockbuster potential,” states Morten Albrechtsen, MD and CEO at ENKAM.
FGLL emerged from ENKAM’s research of the protein NCAM (the Neural Cell Adhesion Molecule). FGLL is a synthetic peptide able to prevent and contra-act beta-amyloid accumulation, the major hallmark of Alzheimer’s disease. Furthermore, FGLL seems to prevent brain cells from dying and to restore the functionality of the already affected brain cells.
“FGLL belongs to a novel class of drugs, namely the NCAM mimetics that selectively target the FGF receptor in the brain. In the preclinical research, FGLL reduced amyloid load, protected neurons from dying and normalized short and long term memory,” explains the Head of Clinical Development Ravi Anand, MD, who has been working for more than two decades in clinical development, where he has developed several marketed CNS treatments.