Seaside Therapeutics granted U.S patent covering methods of treating autism

Feb 10 2010

Seaside Therapeutics LLC today announced the issuance of U.S. patent 7,648,993 B2 (‘993 patent), which covers methods of treating autism with group 1 antagonists of the metabotropic glutamate receptor (mGluR) pathway. An earlier related patent, U.S. patent 6,890,931 B2 (‘931 patent), was issued in 2005 and covers methods of treating Fragile X Syndrome, the most common known cause of autism, with group 1 antagonists of the mGluR pathway. Related patents have also issued in Europe (EP 1 392 363 B1) and have been allowed in Canada. Together, these patents form the foundation of Seaside’s intellectual property estate. The method of use claims in these patents reflect critical observations of the mGluR pathway and its implications in the causation of Fragile X Syndrome, autism and other disorders of brain development.

“The ‘993 autism patent and the ‘931 Fragile X patent are cornerstones in our intellectual property portfolio and support the development of targeted therapeutics that regulate the mGluR pathway to potentially correct or fundamentally alter the course of brain development and function in brain development disorders.”

Groundbreaking research conducted by Seaside Therapeutics' scientific founder, Mark F. Bear, Ph.D., Howard Hughes Medical Institute Investigator and Picower Professor of Neuroscience at the Massachusetts Institute of Technology, demonstrated that the mGluR5 signaling pathway is disrupted in patients with Fragile X Syndrome. Further research based on these findings has provided insight for developing novel medications to normalize the function of the mGluR pathway, which Seaside believes will extend into a number of brain developmental disorders, including autism.

“The mGluR pathway plays a critical role in the development of Fragile X Syndrome and autism,” said Randall L. Carpenter, M.D., President and Chief Executive Officer of Seaside Therapeutics. “The ‘993 autism patent and the ‘931 Fragile X patent are cornerstones in our intellectual property portfolio and support the development of targeted therapeutics that regulate the mGluR pathway to potentially correct or fundamentally alter the course of brain development and function in brain development disorders.”

Seaside is currently investigating two clinical stage candidates: STX209, which reduces glutamate signaling in the brain and should, thereby, indirectly inhibit excessive mGluR mediated protein synthesis; and STX107, a highly potent, selective mGluR subtype 5 antagonist. A Phase 2 trial of STX209 in Fragile X Syndrome has completed enrollment and a second Phase 2 trial in autism spectrum disorders is actively enrolling patients. Data from both of these studies is anticipated in the first half of 2010. STX107 is in Phase 1 clinical studies in healthy volunteers and is expected to begin enrolling patients with Fragile X Syndrome in a Phase 2 study in the second half of 2010.

Seaside Therapeutics is the exclusive, worldwide licensee of the aforementioned patents, which were licensed from Brown University and Emory University, in 2001. Mark Bear, Kimberly M. Huber, Ph.D., Associate Professor of Neuroscience at the University of Texas Southwestern Medical Center, and Stephen T. Warren, Ph.D., Professor of Biochemistry and of Pediatrics at Emory University School of Medicine, are the inventors of this patent family. Drs. Bear and Huber were formerly at Brown University. All three serve on Seaside’s Scientific Advisory Board.