Biomed Industries Announces Results of Phase 1B Pilot Study for Treatment of Depression
The Californer/10250757

SAN JOSE, Calif. - Californer -- Biomed Industries, Inc. (Biomed) announced results today from its Phase 1B clinical trial of NA-831 for the treatment of Major Depressive Disorder (MDD). The Phase 1B pilot study was a randomized, double-blind, fixed-dose, placebo-controlled, active reference study to investigate the efficacy, safety, and tolerability of two fixed doses (20 and 40 mg/d) of NA-831 vs. placebo after 6-week treatment in 32 adult patients with major depressive disorder (MDD). Venlafaxine XR was used as the active reference.

The difference between active treatment and placebo of ∼7 points on the MADRS

translates into a clinically relevant difference in response rates of 32.5 % units,

compared to an average of 16% units for antidepressants approved by the FDA and European health authorities. Treatment with NA-831 for 6 weeks was well tolerated and efficacious in reducing depressive and anxious symptoms in patients with MDD, and with fewer adverse events than drugs currently on the market.

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According to the WHO, major depressive disorder is one of the leading causes of disability. Approximately 21 million adults in the US and 350 million people worldwide suffer from this mental disorder. Even though there are drugs developed for the management of depression, one of the challenges in dealing with this disease is that a significant portion of the patients develop treatment-resistant depression in which the patients fail to respond to drugs or other therapeutic approaches.

"NA-831 can serve as a potential anti-depressive agent by increasing the extracellular levels of serotonin (5-HT), noradrenaline, dopamine, acetylcholine and histamine in rat prefrontal cortex and hippocampus." Said Lloyd L. Tran, CEO of Biomed Industries, Inc. He continued: "The previous Phase 2A trials of NA-831 showed proof of safety and efficacy for the treatment of Alzheimer's disease. The studies also link the correlation between major depressive disorder and Alzheimer's disease. We are excited about the results of this human Phase 1B study and are designing the protocol for a Phase 3 study".

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About Biomed Industries, Inc.

Biomed Industries™, Inc. is a bio-pharmaceutical company committed to the development and commercialization of new drug therapeutics for unmet needs. Biomed is a leading innovator, having discovered a new family of clinical stage drugs for the treatment of Alzheimer's disease and other neurological disorders. The Company is also developing new applications of AI for drug discovery, clinical trials recruitment and execution, and other mission critical areas in the pharmaceutical and medical device industry. For more information, please visit https://www.biomedind.com

CONTACT

Michael Willis
Biomed Industries, Inc.
San Jose, CA 95131 USA
Tel. 800-824-5135
Email: media@biomedind.com