A new type of antidepressant drug with a novel mechanism of action, which acts on a new target, has entered Phase I clinical trials. The drug could represent a new generation of psycho-active compounds that are devoid of the problems seen with existing treatments.
There are many issues with current therapies for these disorders, particularly for depression. Selective Serotonin Reuptake Inhibitors (SSRI) are the current choice. However, there is a 3-week gap for the drug to take effect. During this period the person becomes anxious for the drug to work and then more depressed because they feel the drug isn't working.
By addressing the anxiety in the period before the antidepressant activity begins to work, Neuro3d hope this new compound, ND7001, will address this problem.
"Due to its entirely novel mechanism of action, ND7001 possesses certain attributes that, if translated and confirmed in humans, could result in a completely new option for patients allowing the simultaneous treatment of depression and anxiety," noted Charles Woler, CEO of Neuro3d
Initially, a double-blind, placebo-controlled, single, dose-escalation study will be conducted to investigate safety, tolerability and pharmacokinetics. A follow up multiple-dose study will be conducted which will also include qEEG recordings to provide evidence of CNS effects and active dose range.
"ND7001 is the first drug of its kind to enter clinical development," noted Cesare Mondadori, CSO of Neuro3d . "The drug acts via a new mechanism and is well tolerated in preclinical studies. Our studies in animals show that ND7001 not only meets the criteria of an antidepressant but also of an anxiolytic compound."
In June last year, Neuro3d started trials of its orally active phosphodiesterase-4 (PDE4) inhibitor in depression, resurrecting the use of this class of drug in this indication. The decision to advance the drug, called ND1251 into clinical trials comes after animal studies suggested that it did not exhibit typical side effects that have held back the clinical use of previously developed PDE4 inhibitors.
In preclinical studies, ND1251 has shown antidepressant, memory enhancing and anti-inflammatory effects. On the basis of these activities ND1251 may also have applications in other disorders, such as multiple sclerosis and certain respiratory diseases.
Depression is the single largest CNS drug market with global antidepressant sales of $19.5 billion in 2003. The WHO estimates that about 340 million people suffer from depression worldwide but only 20 per cent of patients with clinical depression receive treatment.
Many patients are underserved by or do not respond to currently available treatments and existing therapies, such as the selective serotonin reuptake inhibitor class, have a number of limitations such as delayed onset of anti-depressant activity and side effects. Accordingly, there is great demand from physicians and patients for new types of therapies that work via new mechanism of actions and do not share these side effects.