Tonix Pharmaceuticals Holding Corp. announced an exclusive agreement to in-license a triple reuptake inhibitor (TRI), TNX-1600 (formerly D-578), to treat posttraumatic stress disorder (PTSD) and potentially other central nervous system (CNS) disorders. The compound was developed and pharmacologically characterized by Aloke Dutta, Ph.D., professor of Pharmaceutical Sciences at Wayne State University, with funding from a National Institutes of Health grant (grant number MH084888), and the patents covering the compounds were licensed to TRImaran Pharma, Inc. (TRImaran). The transaction announced today is a license agreement with Wayne State and an asset acquisition with TRImaran.
“We are excited to expand our pipeline and are looking forward to developing TNX-1600 as a potential treatment for PTSD,” said Seth Lederman, M.D., Tonix’s President and Chief Executive Officer. “We plan to utilize our clinical experience in PTSD to evaluate the therapeutic benefit of TNX-1600. PTSD is a heterogeneous condition, so we believe different PTSD patients may respond to different medicines. In some cases, more than one drug will be required for effective treatment. TNX-1600 is our third drug candidate in development for PTSD. Our most advanced candidate is TNX-102 SL, which is in Phase 3 development. We are also developing TNX-601 which is entering a Phase 1 trial imminently. TNX-1600 is in the pre-IND phase of development with encouraging data from animal models of PTSD.”
Frank Bymaster, Chief Scientific Officer and co-founder of TRImaran Pharma Inc. said, “TNX-1600 is a novel TRI that inhibits simultaneously the reuptake of three key neurotransmitters: serotonin, norepinephrine and dopamine. Each of these three neurotransmitters plays a key modulatory role in many CNS processes. Inhibiting reuptake of all three may provide an effective treatment for PTSD.”
According to Dr. Aloke Dutta, “We have developed an innovative triple reuptake inhibitor, D-578, based on a unique pyran molecular scaffold to address the current therapeutic needs for PTSD and other neurological disorders. Based on our preliminary data, we expect a pharmacological synergy from their potent modulatory effect on the level of monoamine neurotransmitters in the brain which should facilitate effective treatment of these disorders.”
Under the terms of the agreement, Tonix has been granted an exclusive license from Wayne State University for technology and patents related to TNX-1600 and other pyran-based compounds. Another member of the class, D-473, has also shown effects in a rodent model of depression.