Faust Pharmaceuticals' Phase IIa Results For Parkinson's Disease Showed Good Tolerance And Combination Of Therapeutic Effects

Main Category: Parkinson's Disease
Also Included In: Clinical Trials / Drug Trials
Article Date: 07 Jun 2007 - 1:00 PDT

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Faust Pharmaceuticals S.A., a clinical stage product company specializing in the discovery and development of drugs for diseases of the nervous system, today announced that the Phase IIa clinical trial results of its small molecule glutamate release inhibitor, FP0011, are being presented at the Movement Disorder Society (MDS)'s 11th International Congress of Parkinson's Disease and Movement Disorders, taking place this week in Istanbul, Turkey. The poster, presented by the study's Principal Investigator, Olivier Rascol, M.D., of University Hospital, Toulouse, has been selected for presentation at the Highlights of Posters session during the conference.

In the trial, FP0011 was well tolerated and improved Parkinsonian symptoms as measured by the Unified Parkinson's Disease Rating Scale (UPDRS), as well as motor fluctuations as measured by patient diaries. The compound had positive effects in three critical areas: "core" Parkinsonian motor symptoms (such as tremor, rigidity and akinesia), axial symptoms not sensitive to L-dopa and other commonly-prescribed dopaminergic drugs (such as disturbance of posture, balance and gait), and dyskinesia (i.e. the jerky uncontrolled movements that result as a side effect of long term L-dopa therapy).

The Phase IIa trial was conducted according to an innovative "n of 1" trial design in which a small population (n=8) of mid-to-late stage Parkinsonian patients with L-dopa-induced motor complications were administered FP0011 or placebo over 4 cross-over periods on a randomized, blinded basis.

Professor Rascol, Dr. Joaquim Ferreira (Lisbon), and Dr. Lucette Lacomblez (Paris), were principal investigators in this Phase II trial. The "n of 1" trial design was previously used by Dr. Ferreira to confirm that amantadine, originally developed as an antiviral and now commonly used to address side effects of L-dopa therapy, could help Parkinson's patients.

"The differentiated profile observed in this Phase II trial is interesting and intriguing as there are currently no other drugs with this combination of therapeutic effects," said Professor Rascol. "Particularly if the therapeutic effect on non-levodopa sensitive symptoms can be confirmed in the Phase IIb and subsequent trials, the compound would address a very important unmet medical need for all mid-to-late stage patients developing postural disturbances, and could represent a significant advance in approaches to Parkinson's disease."

Also being presented at the conference is a poster on the results of FP0011 in a MPTP macaque monkey model of Parkinson's disease, by Dr. Jonathan Brotchie, CEO of Atuka Ltd. of Toronto, Canada. In this trial, monkeys that have developed dyskinesia from the administration of L-dopa to treat Parkinsonian symptoms from the neurotoxin, MPTP, were administered FP0011. FP0011 reduced the severity of L-dopa-induced dyskinesia while extending the duration of the anti-Parkinsonian action of L-dopa.

"Unlike other drugs on the market that increase the duration of L-dopa action, FP0011 did not exacerbate the problem of dyskinesia," said Dr. Brotchie. "If these effects were seen in patients, then over the course of a day such an action could significantly enhance the quality of life of people with advanced Parkinson's disease."

Commenting on these presentations, Thomas Seoh, CEO of Faust noted that: "These mutually supportive data in the Phase IIa trial and the MPTP monkey trial presented at this conference strongly support the further clinical development of FP0011 as an adjunctive therapy to L-dopa in patients with established motor complications. We look forward to confirming and extending these results in larger trials for Parkinson's patients. Ultimately, we hope to demonstrate that FP0011 can be a potent, safe glutamate release inhibitor that could have a role in other neurological diseases and conditions where excess glutamate has been implicated, such as Alzheimer's disease, ALS, Huntington's disease, multiple sclerosis and neuropathy."

About Parkinson's disease

Parkinson's disease affects both men and women in almost equal numbers with no apparent social, ethnic, economic or geographic links. In the United States, it is estimated that 60,000 new cases are diagnosed each year, joining the 1.5 million Americans who currently have Parkinson's disease. While the condition usually develops after the age of 65, 15% of those diagnosed are under 50. Estimates range up to about 1,200,000 patients in Europe.

About Faust Pharmaceuticals

Faust Pharmaceuticals is a clinical stage products company specializing in the discovery and development of drugs for diseases of the nervous system. The company's lead compound, FP0011, is a small molecule glutamate inhibitor in Phase II for Parkinson's disease and ALS. A second compound, FP0023, is a fetal gene activating utrophin inducer in preparation for Phase I/II for Duchenne Muscular Dystrophy. The company additionally has pre-clinical programs on targets such as mGluR (metabotropic glutamate receptor), as well as a proprietary drug discovery platform targeting GPCRs (G-Protein Coupled Receptors).

http://www.faustpharma.com

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