RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

The nicotinic antagonist approach, both for mecamylamine and its enantiomer, TC-5214, has been built on the concept of combo therapy. The precedent is Abilify, Abilify was tested as an adjunct to SSRIs in Treatment Resistant Depression, for which it now sells close to a billion dollars worth per year.

This design is different than most TRD trials--but it's a clean way to test an adjunct, for Treatment-Resistant Depression. Here they vet the population for TRD via failure in the trial itself, rather than going on some potentially unreliable history of antidepressant failures. It makes sense given that their first goal is to obtain approval as an adjunct--and leaves open the possibility that some additive/synergistic effect could boost an inadequate response to the monotherapy into something meaningful. It's what worked in Phase IIb, except there, all patients were first tried on Celexa--in this trial, there were a number of SSRI and SNRI drugs allowed. That could introduce some 'static', though Abilify's Phase III testing also included a number of antidepressants, and the FDA would require a range of concurrent drugs. A separate Phase II trial is underway testing TC-5214 as a monotherapy.

NeuroInvestment