Embera NeuroTherapeutics is a clinical-stage pharmaceutical company developing EMB-001, a patented combination of metyrapone and oxazepam designed to target multiple stress-response pathways implicated in addiction relapse. EMB-001 is intended to reduce cravings and loss of control by modulating stress-, cue-, and drug-induced mechanisms distinct from existing addiction treatments. The company is advancing EMB-001 into Phase 2 clinical programs for cocaine use disorder and smoking cessation, with dosing for both studies expected to begin in Q1 2020. Embera completed a Series B financing (amount undisclosed) and says the proceeds, together with grant funding, will support operations and Phase 2 development. It received the final portion of a three-year NIDA award totaling $11.1 million to fund a Phase 2 efficacy study in cocaine use disorder. Embera also received a Rose Research Center award (part of RRC’s five-year Foundation for a Smoke-Free World grant) to support a Phase 2a smoking cessation study and an associated grant to fund manufacturing of EMB-001 clinical trial material. The company strengthened its clinical leadership with Bruce McCarthy, M.D. as Chief Medical Officer and Gary Connor, RN as Chief Operating Officer. Embera NeuroTherapeutics is advancing EMB-001, a patented combination product comprising two FDA‑approved medications (metyrapone and oxazepam) intended to modulate stress pathways that drive craving and relapse. EMB-001 has shown promising results in a published pilot study in cocaine‑dependent humans and in preclinical models of nicotine, cocaine and methamphetamine dependence. The company is advancing clinical programs in smoking cessation and cocaine use disorder and is preparing a Phase 1 combined single- and multiple‑rising‑dose study to evaluate safety and pharmacokinetics in volunteers who smoke cigarettes. The recently announced financing will enable completion of that Phase 1 trial; Embera anticipated initiating dosing within 30 days and producing top‑line data by the end of 2015. HRA Pharma, existing investors, angel groups and private individuals participated in the raise; HRA Pharma’s CEO will serve as a non‑voting observer to Embera’s board. HRA Pharma commercializes Metopirone, whose active component metyrapone is one of EMB‑001’s two molecular components, reinforcing the strategic rationale for the partnership. Embera NeuroTherapeutics is advancing EMB-001, a patented combination of the benzodiazepine oxazepam and the cortisol synthesis inhibitor metyrapone, intended to modulate multiple stress-related pathways that drive craving and relapse. The company is focused on programs in smoking cessation and cocaine dependence and describes itself as development-stage. EMB-001 has shown effects in a published pilot study in cocaine-dependent humans and in preclinical models of nicotine, cocaine, and methamphetamine dependence. The FDA completed review of Embera’s IND and will allow the EMB-001 Phase 1 clinical trial in smokers to begin. Embera was selected as one of four companies to receive a grant through the inaugural Soundaffectslife.org campaign; the grant will support evaluation of EMB-001 in a Phase 1 trial enrolling otherwise healthy individuals who smoke. Contributions to the Soundaffectslife.org campaign are raised for 60 days, qualify as charitable/tax-deductible, and will be awarded after the campaign period. Embera NeuroTherapeutics is a development-stage pharmaceutical company advancing EMB-001, a patent-pending combination therapy for addiction composed of oxazepam and metyrapone that uniquely modulates stress-related pathways and the HPA axis. The company is pursuing clinical programs in smoking cessation and cocaine dependence and reports prior clinical activity for EMB-001 in a randomized, double-blind, placebo-controlled pilot study in cocaine-dependent subjects. Preclinical studies in a nicotine-dependence model produced statistically significant results versus the positive control, varenicline. Embera says proceeds from its recent financing, together with a development grant from the National Institute for Drug Abuse (NIDA), will support completion of preclinical development and a Phase 1 safety study for EMB-001. The company emphasizes the potential of EMB-001 to address craving and relapse by targeting stress mechanisms distinct from existing addiction treatments. Embera references a large smoking-cessation market opportunity and is led by CEO Bob Linke with scientific founder Dr. Nicholas Goeders involved in the discovery work at LSU Health Sciences Center–Shreveport.

Total raised

$7M

Funding rounds

4

Latest round

Series A

Latest activity

Apr 2015