Embera NeuroTherapeutics to Receive Grant for Clinical Trial Through New Crowd Funding Platform
-- Contributors to Sound Affects Life’s platform support clinical trial program for EMB-001, which may reduce lung cancer by helping smokers quit --
-- FDA completes review of EMB-001 investigational new drug (IND) submission allowing the Phase 1 clinical trial in smokers to proceed --
BOSTON & SHREVEPORT, La.--(BUSINESS WIRE)--Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for smoking cessation and other addictions, today announced that Sound Affects Life, a 501(c)3 not-for-profit charity, has selected Embera as part of its inaugural group of companies to receive a grant funded by contributions through Soundaffectslife.org. Soundaffectslife.org, which launches today, is a new crowd funding platform designed to connect individuals with organizations that are actively seeking improved outcomes in cancer. The grant will support the evaluation of EMB-001, the company’s lead drug candidate, in a Phase 1 clinical trial enrolling individuals who smoke but are otherwise healthy.
“To this end, the FDA recently completed their review of our IND submission and will allow the EMB-001 Phase 1 clinical trial in smokers to begin. Contributions to Soundaffectslife.org directly support the ongoing development of our investigational treatment to help people quit smoking.”
Smoking is the leading cause of lung cancer and preventable, premature death in the U.S., killing 480,000 people annually. Nearly half of smokers attempt to quit each year; however, with treatment only 16 percent actually succeed, indicating an urgent medical need to develop a safe and effective treatment to assist smokers who want to “kick the habit.” EMB-001 is designed to modulate multiple stress-related pathways simultaneously to reduce the craving that drives addictions, including nicotine.
“Just a one percent increase in smokers successfully quitting each year could result in fewer deaths due to lung cancer and a U.S. healthcare savings of $1.3 billion to the U.S. healthcare system,” said Bob Linke, Chief Executive Officer of Embera. “To this end, the FDA recently completed their review of our IND submission and will allow the EMB-001 Phase 1 clinical trial in smokers to begin. Contributions to Soundaffectslife.org directly support the ongoing development of our investigational treatment to help people quit smoking.”
Embera is one of four companies raising grant funding through the inaugural campaign of Soundaffectslife.org. Contributions, which qualify as charitable for tax deductions, are being raised for 60 days, after which the grants will be awarded.
EMB-001 is a novel addiction treatment that acts by modulating multiple stress-related pathways simultaneously to reduce the craving that drives addiction and to maximize potential efficacy. EMB-001 acts by mechanisms distinct from those of existing addiction treatments and is based on the contribution of the body's stress response to the acquisition and maintenance of addiction. This patented treatment comprises two FDA-approved medications, the benzodiazepine oxazepam and the cortisol synthesis inhibitor metyrapone.
EMB-001 may substantially reduce craving and loss of control, potentially resulting in long term abstinence from smoking and drug use. Therapies that break these barriers to recovery would be significant contributions to the treatment of a broad range of addictions. EMB-001’s effect has been demonstrated in a published pilot study in cocaine-dependent human subjects, as well as in published pre-clinical models of nicotine, cocaine, and methamphetamine dependence.
About Embera NeuroTherapeutics
Embera NeuroTherapeutics, Inc. is a development-stage pharmaceutical company focused on treating a broad range of addictions where the major clinical challenge is a limited range of effective therapies. Embera is developing a novel drug combination (EMB-001) targeting specific brain functions related to stress response that drive craving and relapse associated with these disorders. Embera is advancing EMB-001 development programs in smoking cessation and cocaine dependence. www.emberaneuro.com