Topline Data from Tal Medical LFMS Study

RNS Number : 9431Z

PureTech Health PLC

01 June 2016

 

PureTech Health plc

PureTech Announces Topline Data from Study of Tal Medical's LFMS Technology in Treatment Resistant Depression

Boston, Massachusetts, June 1, 2016 - PureTech Health plc ("PureTech", LSE: PRTC), a cross-disciplinary healthcare company tackling fundamental medical needs in disruptive ways, today announced topline results from Tal Medical's first study focused on major depressive disorder (MDD). The Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) program evaluated Tal Medical's proprietary Low Field Magnetic Stimulation (LFMS) technology in MDD resistant to one or more antidepressant medications. Topline results of the study, which used the sequential parallel comparison design (SPCD) and its two-stage design, indicated that treatment with LFMS did not achieve the primary endpoint of a 48-hour change in core depression symptoms compared to sham treatment, as measured by the 6-item Hamilton Depression Rating Scale or HAMD6. Some non-statistically significant mood improvements were detected with active LFMS compared to sham 120 minutes after the last administration in each stage. No significant safety concerns were reported during the study.

In two previous randomised, controlled studies focused primarily on bipolar depression, a single, 20-minute LFMS treatment demonstrated a statistically significant immediate effect size greater than existing antidepressant drug treatments typically achieve in 4-10 weeks. RAPID is the first study to evaluate Tal Medical's technology in a clinical trial focused on MDD and also the first to look at the 48-hour time point following the first dose. Tal Medical expects several studies, including a dose optimisation study in MDD and studies in additional indications, to read out by the end of the year.

"Depression affects hundreds of millions of adults globally and is the leading cause of suicide and disability worldwide. There is an incredible unmet need for a safe, rapid-acting treatment since it takes several weeks for medications to take effect," said the study's principal investigator, Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry and Executive Director, Clinical Trials Network and Institute (CTNI), Massachusetts General Hospital. "Many successful, FDA-approved antidepressant drugs have had multiple negative clinical trials. Given the previous positive clinical and preclinical data, I look forward to tracking the progress of LFMS to determine its full potential in MDD, bipolar depression and other indications."

Daphne Zohar, Co-founder and Chief Executive Officer at PureTech, said: "Over the next six months we will have a large amount of data to review as Tal completes multiple studies evaluating dosing, length of effect, mechanism of action and efficacy in other indications. These studies, in addition to Tal's two previous positive studies focused primarily on bipolar depression, will guide our understanding of the full potential for Tal's technology."

About Depression

Depression affects more than 350 million adults globally, and the most common forms are major depressive disorder and bipolar disorder.

Major depressive disorder is primarily treated with antidepressant drugs, yet there remains a vast, unmet need for a safe, rapid-acting treatment. Antidepressants take 4-10 weeks to work, leaving many patients at risk of prolonged suffering, functional impairment or suicide. The current standard of care for acute, unstable or severely depressed patients is hospitalisation. Electro-convulsive therapy (ECT) is often the last resort, despite safety risks, including memory loss.

Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Bipolar disorder is the sixth leading cause of disability in the world.

About the RAPID LFMS Trial

The Rapidly Acting Treatments for Treatment Resistant Depression (RAPID) trial was a double-blind, randomised, sham-controlled, multi-site study of Tal Medical's first-in-class Low Field Magnetic Stimulation (LFMS) technology in 85 treatment resistant major depressive disorder (MDD) patients. Led by Massachusetts General Hospital (MGH), RAPID tested 20 minute LFMS treatment sessions over two and four consecutive days vs. sham and measured the effect durability for one month. The primary endpoint was the reduction in depressive symptoms at 48 hours (24 hours after second treatment) on the 6-item Hamilton Depression Rating Scale (HAM-D-6) total score. Secondary outcomes included other depression measures (e.g., PANAS, VAS, MADRS, CGI) as well as effect durability at a 4-week follow-up. 

This study has been funded in whole or in part with Federal funds from the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN2712011000061.

About Low Field Magnetic Stimulation

Tal Medical is developing a proprietary Low Field Magnetic Stimulation (LFMS) technology that uses a unique magnetic field waveform, with a mechanism of action different from existing treatments, including other brain stimulation techniques such as electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS).

The proof of concept for LFMS was established at McLean Hospital, a Harvard University teaching hospital, in two randomised, sham-controlled studies focused primarily on bipolar depression (N=117). A single 20-minute LFMS treatment in these studies demonstrated, with no major side effects, an immediate effect size greater than antidepressant drug treatment typically achieve in 4-10 weeks.

About Tal Medical

Tal Medical is a clinical-stage technology company developing a rapid-acting, non-invasive neuromodulation therapy for depression. The company aims to redefine the clinical practice of psychiatry by introducing the first safe, acute depression treatment as a standard of care. Tal Medical was founded in conjunction with leading scientists in the fields of depression and neuromodulation.

About PureTech Health

PureTech Health (PureTech Health plc, PRTC.L) is a cross-disciplinary healthcare company developing innovative products that could improve the lives of patients. PureTech is focused on areas of growing scientific and technical insights that it believes are at an important inflection point, including the central nervous, gastro-intestinal and immune systems, and the interactions and signaling between them. PureTech has approximately 20 clinical studies across its pipeline targeting multi-billion dollar market opportunities, including six human proof-of-concept studies and multiple pivotal or registration study readouts expected in the next two years. While inevitably some technologies will not advance to commercialisation, PureTech's approach preserves its options as most of the cash resides on a PureTech parent company level, allowing PureTech to build value and divert cash to its most successful programs as milestones are achieved. PureTech has over 220 patents and patent applications. PureTech's leading team and board, along with an advisory network of more than 60 expert founder-scientists and advisors across multiple disciplines, gives PureTech access to potentially ground-breaking science and technological innovation. With healthcare undergoing major transformation, PureTech believes it is well positioned to develop and launch medicines for the 21st century. For more information, visit www.puretechhealth.com and connect with us on Twitter.

Forward Looking Statement

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

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For further information, please contact:

PureTech
Julie DiCarlo, Senior Vice President, Communications and Investor Relations	[phone]
FTI Consulting (Communications adviser to PureTech) Ben Atwell / Matthew Cole	[phone]

 

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