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Recent discoveries by Seaside Therapeutics scientific founder, Dr. Mark Bear, revealed a molecular pathway that is disrupted in a specific disorder of brain development and provided insights for developing novel medications to normalize function of this pathway. Based upon these insights, Seaside Therapeutics licensed from Merck Pharmaceuticals a novel series of compounds targeting a specific receptor in this pathway. As predicted, the lead compound from this series demonstrated robust efficacy in the relevant animal model. Seaside is currently conducting a standard set of preclinical studies necessary to open an Investigational New Drug application with the Food and Drug Administration. Assuming an acceptable safety profile, Seaside intends to initiate clinical trials in humans in 2008. We have identified additional novel drug classes that we predict will normalize function in this pathway and intend to in-license the best compounds and rapidly develop these medications for human use. Although our lead compound has great promise, we do not expect it will provide maximal benefit for all individuals in need of treatment. Autism and many other disorders of brain development appear to result from complex and multivariate neurobiological dysfunctions and we therefore anticipate significant variability in response to any single drug treatment. We believe it will be necessary to extensively characterize each individual and will assess the complex interactions of genetics, cellular pathways, environment, behavioral and non-drug therapies in our trials. Analysis of these complex datasets will guide drug development and facilitate identification of new drug targets.
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