Navitor Expands Leadership Team with Appointment of James Randall Owen, M.D. as Chief Medical Officer

“Randy has deep expertise in the CNS space, with a proven track record of successful drug development spanning from early-stage research, to late-stage clinical studies, and through regulatory approvals,” commented Dr. Hughes. “His experience will be invaluable to Navitor as we advance the development of our first-in-class sestrin modulator NV-5138 in treatment resistant depression and focus the applications of our proprietary mTORC1 modulation platform into additional relevant diseases. We are thrilled to welcome Randy to the Navitor team.”

Prior to joining Navitor, Dr. Owen served and Senior Vice President, Clinical Development and Chief Medical Officer at Acadia, where he led the development of pimavanserin, a 5HT2a inverse agonist, for the treatment of Parkinson’s disease psychosis, as well as dementia-related psychosis, depression, and schizophrenias. Previously, Dr. Owen served as Vice President, U.S. Clinical Affairs at Lundbeck LLC from 2010 to 2016, where he directed the evaluation of compounds across a range of neurological and psychiatric disorders, including pediatric epilepsies, stroke, Alzheimer’s disease, and neurogenic orthostatic hypotension. Earlier in his career, Dr. Owen served in positions of increasing responsibility at Abbott (now Abbvie) and Merck, where he worked on an array of neuroscience compounds, including substance P antagonism and GABA subtype selective modulators. He also served as Group Director, Global Clinical Research at Bristol-Myers Squibb Company where he co-led the life-cycle management of aripiprazole during a period of product extensions in psychiatric indications in the United States and Europe. Dr. Owen received his B.A. at Haverford College, his M.D. at East Tennessee State University, Quillen College of Medicine and completed his psychiatric residency at Emory University.

“Navitor’s unique ability to directly and selectively modulate intracellular mTORC1 represents a significant advance in therapeutic approaches to severe depression and related neuropsychiatric illnesses,” commented Dr. Owen. “Modulation of mTORC1 also has the potential to address other important medical conditions, such as renal disease. Altogether, I’m excited to join this team of talented scientists who are committed to advancing our understanding of medical and mental illnesses and to bring forward promising new therapies to patients in need.”

About NV-5138

NV-5138 is an orally bioavailable small molecule that directly and transiently activates mTORC1, the master modulator of cellular metabolism, which is suppressed in the brain of patients suffering from depression. NV-5138 binds to and modulates sestrin, a recently discovered cellular sensor protein for the amino acid leucine, a potent natural activator of mTORC1. As opposed to many other organ systems like skeletal muscle, leucine is a poor activator of mTORC1 in the brain since it is principally used as a metabolic precursor for neurotransmitter and protein synthesis. NV-5138 was designed to avoid the metabolic fate of leucine in the brain and thus serves as an effective activator of mTORC1 in this tissue. Results from preclinical models demonstrate that oral administration of NV-5138 produces rapid upregulation of key synaptic proteins, synaptic remodeling in the prefrontal cortex and hippocampus, sustained antidepressant behavioral responses, cognitive improvements and compound-specific spectral power changes, as measured by quantitative electroencephalography (qEEG). Navitor’s strong intellectual property portfolio includes issued composition of matter patent protection for NV-5138 and related compounds.

About mTORC1

mTORC1, or Complex 1 of the mechanistic target of rapamycin, activity governs the pace and ability of the cell to synthesize protein and other cellular components. Increased mTORC1 activity contributes to a broad array of diseases of aging by increasing protein misfolding and driving cellular stress, inflammation, and fibrosis. In other disease states such as severe depression, inadequate mTORC1 activity contributes to disease pathology by limiting energy utilization and protein synthesis, leading to impaired function. Multiple preclinical studies have shown that mTORC1 activation is required for the efficacy of many rapid-acting antidepressant compounds, including but not limited to modulators of the N-methyl-D-aspartic-acid (NMDA)-mediated signaling pathway like ketamine.

About Navitor

Navitor Pharmaceuticals, Inc. is the leader in the development of mTORC1-targeted therapeutics designed to help patients live longer and healthier lives. The Company’s proprietary platform enables specific modulation of mTORC1, the gatekeeper of cellular metabolism and renewal, with the first-ever absolutely selective mTORC1 inhibition and the unique ability for mTORC1 activation. Navitor’s lead clinical-stage candidate, NV-5138, is a small molecule that directly activates mTORC1 by binding to sestrin, a key regulatory component of the mTORC1 complex that recognizes the essential amino acid leucine, and is being developed for treatment-resistant depression, with additional opportunities in cognition and memory. The Company’s NΛValog program, which provides unprecedented selectivity in mTORC1 inhibition, is initially targeting chronic kidney disease and has broad potential application for age-related diseases. For more information, please visit www.navitorpharma.com.

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