Tal's New Rapidly Acting Depression Treatment Awarded Funding for Clinical Trial in Prestigious NIMH "RAPID" Program

BOSTON, Jan. 10, 2014 /PRNewswire/ -- The National Institute of Mental Health has prioritized the development of a rapidly acting treatment for depression as a key research goal.  As a result, NIMH created the Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) program to identify and test promising antidepressant interventions. Tal Medical's LFMS technology was selected to be tested in the first trial as part of the RAPID program.  Historically, depression treatments have focused on molecular-based approaches targeted at a family of neurotransmitters and require weeks of therapy before for a clinical benefit is achieved.  Modern science is increasingly associating the pathophysiology of depression, and other neuropsychiatry conditions, with dysfunction in specific brain areas and circuits.  Tal Medical Inc. (Tal) is developing an innovative, non-invasive, neuromodulation technology that seeks to normalize this neurocircuitry dysfunction. Tal's first-in-class Low Field Magnetic Stimulation (LFMS) device is based on a discovery from McLean Hospital, a leading psychiatric research hospital.

"There is a well-documented lack of innovation in the field of antidepressant drug development and LFMS has the potential to break this paradigm and offer patients a clinical profile completely different from that of current therapies" said Steve Paul, M.D., "The sham-controlled data with LFMS indicate an antidepressant response within minutes of patients receiving a single 20 minute LFMS treatment."  Dr. Paul was President of Lilly Research Laboratories at Eli Lilly and Company, where his teams led the development and launch of the current market leading antidepressant, Cymbalta, along with other important psychiatric medicines such as Zyprexa and Strattera. Dr. Paul is the Chairman and a Co-founder of Tal. "We look forward to building on our exciting clinical data on LFMS via the RAPID program.  The selection of LFMS as the first treatment to be tested brings significant validation to the technology," added Dr. Paul. 

Depression is one of the most common and serious mental health disorders, affecting 6-7% of the US adult population annually.  Over 270M antidepressant prescriptions are filled annually and generated over $9B in sales in the US in 2012. While there are many treatment options available to clinicians, all currently available antidepressants require several weeks to work and unfortunately, many patients respond only partially or not at all.  The time delay of response and the refractory nature of depression can lead to tragic outcomes like severe disability and suicide. 

"A therapy that acts quickly would be a major step forward for the field given the significant time lag to onset of current therapies" said Maurizio Fava, MD, Executive Vice Chair of the Department of Psychiatry at the Massachusetts General Hospital (MGH) and Executive Director of the MGH Clinical Trials Network and Institute (CTNI).  "We are delighted to be part of the RAPID program to help develop the next generation of antidepressant therapies, and particularly excited to be testing this intriguing technology which has the potential to help so many patients."

The National Institute of Mental Health (NIMH) Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) program put together a steering committee of independent key opinion leaders and staff from both NIMH and MGH to evaluate the top industrial and academic proposals for novel drug and device treatments. Of all the treatments reviewed, Tal's LFMS technology was selected as the most promising, innovative treatment option, and NIMH is funding a 90-subject proof-of-concept study comparing LFMS to sham treatment to assess its rapid antidepressant efficacy in patients with treatment resistant Major Depressive Disorder. The MGH was awarded National Institute of Mental Health contract #HHS-NIH-2011-00006I to conduct the multi-site clinical trials as part of the RAPID program.  The LFMS RAPID trial has launched and is currently recruiting patients (www.clinicaltrials.gov) at six leading academic medical centers: The Massachusetts General Hospital, Yale University, Mount Sinai School of Medicine, The University of Texas-Southwestern Medical Center, Emory University and the University of Alabama-Birmingham. 

About Depression

Depression is a disabling mental illness characterized by persistent feelings of sadness, hopelessness, irritability, loss of interest, fatigue, sleep disruption, pain and suicidal thoughts, among other symptoms. These symptoms interfere significantly with normal social, family, and work functioning and the World Health Organization reports that depression is the leading disease-related cause of disability in the US and Canada.  In addition to limitations in the efficacy offered by current antidepressant medications, patients often experience significant adverse events including sleep disruption and sexual dysfunction and all antidepressant medications have a black box warning from the FDA about the potential increase of suicidal thinking and behavior in patients under the age of 24. 

About Tal and LFMS:

Tal Medical, Inc. (www.talmedical.com) is a privately-held, Boston-based medical device company pursuing the development of low field magnetic stimulation (LFMS) for the treatment of depression and other neuropsychiatric disorders.  LFMS is a first-in-class, non-invasive, neuromodulation technology. Tal's table-top LFMS device works through a completely novel mechanism of action compared to any existing depression treatment.   LFMS uses an external electromagnetic coil to apply a time-varying magnetic field to the brain, which induces a time-varying electrical field.  LFMS uses electric fields that are orders of magnitude different from the existing neuromodulation technologies electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).  Tal was founded in 2010 by PureTech (www.puretechhealth.com), in conjunction with leading scientists in the fields of depression and neuromodulation. The LFMS technology was licensed from McLean Hospital.

SOURCE Tal Medical, Inc.