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Sibia Neurosciences, Inc. Files IND on Therapeutic Compound for Parkinson's Disease Source: PR Newswire LA JOLLA, Calif., Dec. 18 /PRNewswire/ via Individual Inc. -- SIBIA Neurosciences, Inc. (Nasdaq-NNM: SIBI) today announced that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a Phase I clinical trial of SIB-1508Y, the Company's proprietary compound for Parkinson's disease. SIB-1508Y is one of several new classes of compounds discovered by SIBIA that are selective for specific human receptor/ion channel subtypes in the brain. These receptor subtypes modulate communication between nerve cells and play a key role in a variety of neurological disorders. SIB-1508Y is selective for certain nicotinic acetylcholine receptor (NAChR) subtypes that regulate the release of dopamine and acetylcholine. A deficiency of dopamine has been shown to be a major factor in the onset and progression of Parkinson's disease, and acetylcholine is presumed to be important to cognitive dysfunctions of the disease. Current therapy for Parkinson's disease rests on the principle of dopamine replacement, usually through the administration of L-dopa, the natural precursor of dopamine. L-dopa, however, typically has a therapeutic usefulness of approximately five years due to drug related side effects. In addition, the administration of L-dopa does not alleviate the deficiency observed in other neurotransmitters such as acetylcholine, nor does it generally demonstrate efficacy against the non-motor symptoms such as cognitive dysfunction or depression associated with Parkinson's disease. In contrast, SIBIA believes SIB-1508Y may be effective for the treatment of the motor, affective and cognitive dysfunctions of Parkinson's disease. In a variety of animal models of Parkinson's disease, SIB-1508Y has been shown to be selective for specific neuronal NACh receptors and has demonstrated efficacy in evaluations of motor improvements and the amelioration of cognitive deficits associated with the disease. Since SIB- 1508Y exhibits strong receptor selectivity, studies are planned to investigate its effects on all aspects of Parkinson's disease. The initial Phase I trial will focus on the evaluation of the safety and pharmocokinetics of SIB-1508Y in a rising dose study of healthy male volunteers under both fasted and fed conditions. Based on the results of this study, SIBIA plans to conduct Phase I/Phase II studies to further evaluate SIB-1508Y for the treatment of Parkinson's disease. Parkinson's disease is a progressive neurodegenerative disorder displaying deterioration of motor functions, and is often accompanied by depression and dementia. The disorder affects an estimated 800,000 people in the United States, with about 50,000 new cases reported each year in the U.S. About two- thirds of patients diagnosed with the disease are disabled within five years of diagnosis. There currently is no cure for Parkinson's disease and no treatment which stops its degenerative course. Commenting on the announcement, SIBIA President and CEO William T. Comer, Ph.D., stated, "This is an important milestone for the Company since it is the first SIBIA-discovered compound to enter the clinical development process. We are proud of this achievement, and pleased with the fact that we are on schedule relative to our development timetable for SIB-1508Y. Given the growing prevalence of Parkinson's disease and its associated medical and societal costs, it is our hope that our efforts will lead to a new therapy for treating the full range of dysfunctions suffered by Parkinson's disease patients." SIBIA Neurosciences, Inc. is engaged in the discovery and development of novel, small molecule therapeutics for treating disorders of the nervous system based on its unique approach to characterizing the molecular processes involved in such disorders. SIBIA is focusing its efforts on developing compounds for the treatment of Parkinson's disease, Alzheimer's disease, stroke, head trauma, epilepsy, chronic pain, schizophrenia and other disorders. The Company currently has collaborations with Eli Lilly and Company, CIBA-GEIGY Limited (Novartis) and Bristol-Myers Squibb Company. This press release contains forward-looking statements that involve risks and uncertainties. As a result, actual results could differ materially from those discussed herein. These risks and uncertainties include SIBIA's early stage of development, the new and uncertain state of SIBIA's technologies, SIBIA's future capital needs and the uncertainty of receiving additional funding, uncertainties regarding patents, proprietary rights and regulatory matters, and other research, development and market risks. These and other risks and uncertainties are more fully set forth in SIBIA's Prospectus included in its Registration Statement on Form S-1 filed in connection with its initial public offering, as well as in SIBIA's most recently filed Form 10-Q. SOURCE Sibia Neurosciences, Inc. /CONTACT: William T. Comer, Ph.D., President and Chief Executive Officer, or Michael J. Dunn, Vice President, Business Development, 619-452-5892/ (SIBI) CO: Sibia Neurosciences, Inc. ST: California IN: MTC SU: SK-DM -- LAW080 -- 8911 12/18/96 16:21 EST http://www.prnewswire.com [12-18-96 at 12:00 EST, PR Newswire]