FDA Approves NeuroGenetic Pharmaceuticals Application to Begin Clinical Trials for Its NGP 555 Compound to Treat and Prevent Alzheimer’s Disease

SAN DIEGO, Sep 29, 2014 (BUSINESS WIRE) — The U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application from NeuroGenetic Pharmaceuticals, Inc. (NGP) to begin clinical trials on its NGP 555 compound to treat and prevent Alzheimer’s disease (AD). The approval follows successful completion of all preclinical phases under a fast-track grant from the National Institute of Neurologic Disease and Stroke (NINDS).

Dr. William T. Comer, CEO of NGP, a privately held biopharmaceutical company focused on Alzheimer’s disease therapeutics, said NGP completed pre-clinical toxicology and safety studies of NGP 555 under Small Business Innovation Research (SBIR) grants from the NINDS, grant no. 1U44NS073133-01A1 totaling $3.4 million. The efficacy studies showed beneficial and chronic effects on amyloid biomarkers, pathology, and cognition while lacking the side effects of other compounds and mechanisms for preventing Alzheimer’s disease (AD).

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Global Alzheimer Disease-300 Different Compounds Classified and Described-2014

http://www.researchandmarkets.com/research/6srq42/alzheimer_disease) has announced the addition of Jain PharmaBiotech’s new report “Alzheimer Disease – New Drugs, Markets and Companies” to their offering.

Alzheimer’s disease remains a challenge in management. With nearly 8 million sufferers from this condition in the seven major markets of the world and anticipated increases in the future. Considerable research is in progress to understand the pathomechanism of the disease and find a cure. The only drugs approved currently are acetylcholinesterase inhibitors but they do not correct the basic pathology of the disease, beta amyloid deposits and neurofibrillary tangles. Several new approaches emphasize neuroprotection as well.

Early diagnosis of Alzheimer’s disease is an important first step in management. Several biomarkers in cerebrospinal fluid, blood and urine can detect the disease. They provide a valuable aid to the clinical examination and neuropsychological testing which are the main diagnostic methods supplemented by brain imaging. Genotyping, particularly of ApoE gene alleles is also useful in the evaluation of cases and planning management.

The current management of Alzheimer’s disease is reviewed and it involves a multidisciplinary approach. Acetylcholinesterase inhibitors are mostly a symptomatic treatment but some claims are made about a neuroprotective effect. Currently the only approved neuroprotective therapy in is memantine. Management of these patients also require neuroleptics for aggressive behavior and antidepressants. There is an emphasis on early detection at the stage of mild cognitive impairment and early institution of neuroprotective measures. The value of mental exercise in delaying the onset of Alzheimer’s disease is being recognized.

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Dead Ends in Alzheimer’s Research Expose Need for New Drug Studies

A review of existing research for pharmacological answers to Alzheimer’s disease (AD) catalogs a litany of failures and calls for an aggressive re-dedication to increase the AD drug development pipeline.

The first of its kind research study is published in the journal Alzheimer’s Research & Therapy.

“Our goal was to examine historical trends to help understand why Alzheimer’s disease treatment development efforts so often fail,” said Jeffrey L. Cummings, M.D., Sc.D., director of the Cleveland Clinic.

“With an estimated 44 million people living worldwide with the condition, the study shows that the Alzheimer’s disease drug development ecosystem needs more support given the magnitude of the problem.”

The comprehensive look at all clinical trials underway revealed:
•• there are relatively few drugs in development for Alzheimer’s disease;
•• the failure rate for AD drug development is 99.6 percent for the decade 2002-2012;
•• the number of drugs has been declining since 2009.

Using the advanced search mechanisms of ClinicalTrials.gov, a government website that records all ongoing clinical trials, Dr. Cummings, along with Kate Zhong, M.D., senior director of clinical research and development, and Touro University medical student Travis Morstorf, constructed a comprehensive analysis to examine all trials since 2002.

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