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PureTech Health Says Tal Medical Study Misses Primary Endpoint

1st Jun 2016 15:46

LONDON (Alliance News) - PureTech Health PLC Wednesday said the first study of subsidiary Tal Medical's Low Field Magnetic Stimulation technology in major depressive disorder failed to reach its primary endpoint.

The primary endpoint was a 48 hour change in core depression symptoms as measured by the six-item Hamilton Depression Rating Scale compared to sham treatment.

Some non-statistically significant mood improvements were detected with the technology compared to sham 120 minutes after the last administration in each stage of the study.

Two previous studies focused on bipolar depression show that a 20 minute treatment using the technology demonstrated a "statistically significant immediate effect size greater than existing antidepressant drug treatments typically achieve in 4-10 weeks."

"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," said the study's principal investigator, Maurizio Fava, in a statement.

Fava is executive vice chair of the Department of Psychiatry and executive director of the Clinical Trials Network and Institute at Massachusetts General Hospital.

"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," said PureTech Chief Executive Daphne Zohar in a statement.

Shares in PureTech closed flat at 126.00 pence Wednesday.

By Hana Stewart-Smith; [email protected]; @HanaSSAllNews

Copyright 2016 Alliance News Limited. All Rights Reserved.


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