REL-1017 (dextromethadone) in Depression

The activation of NMDA receptors has been associated with depression and it is expected that d-Methadone will have a fast onset therapeutic effect by blocking this activity.

REL-1017 Development Pipeline

Indication 2018 2019
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
Major Depressive Disorder Rel-1017 Ph2aCandidate profile is in development at this time.Candidate profile is in development at this time.Candidate profile is in development at this time.Candidate profile is in development at this time.Candidate profile is in development at this time.Development of this candidate profile is expended to end at this timeCandidate is not in development in this quarterCandidate is not in development in this quarter
*Depends on preclinical results, FDA feedback and available capital resources.
Clinical
Preclinical

Key Points

  1. Rapid Onset
    1. NMDA antagonists have demonstrated rapid onset (within ~24 hours) of antidepressant activity. Currently approved products take several weeks to show effectiveness.
  2. Novel MOA
    1. NMDA antagonists like d-Methadone represent new approach to treating depression with MOA markedly different from currently approved drugs. Traditional antidepressant response rates in controlled trials estimated at ~54% and real-world effectiveness data suggest a somewhat lower rate.
  3. Enhanced Safety
    1. Ketamine and current antidepressant drugs are associated with significant side effects. d-Methadone safety demonstrated across three human clinical trials.
  4. High Unmet Need
    1. ~ 65% MDD patients do not respond to first line antidepressant treatment.
    2. ~ 30% MDD patients do not respond to up to 4 antidepressant treatments.

Market Potential

The World Health Organization (WHO) has estimated that CNS diseases affect nearly 2 billion people globally. As many as 65 million Americans will experience at least one episode of depression in their lifetime As many as 10 million Americans have treatment resistant depression.

The depression treatment market is segmented on the basis of antidepressants drugs, devices and therapies. Antidepressants are the largest market segment. According to Research and Markets, every year more than five billion antidepressant prescriptions are written globally. The antidepressants segment consists of big pharmaceuticals companies like Eli Lily, Pfizer, GlaxoSmithKline and Forest Laboratories. All these companies are branded drug manufacturers. Some of the popular drugs produced by these companies are Cymbalta (Eli Lily) and Effexor and Pristiq (Pfizer).