Notes from recent presentations
In the GS event the question was asked about how do Phase 2 results get duplicated in the critical Phase 3 trials.
Sergio Traversa answers: Good question, can distill it down to two reasons why there is a depression trial fail,
one is the patient selection
and the other is the placebo effect
Why Relmada did well in Phase 2:
First half of test was in clinic, good control of placebo
Relmada uses two diagnostic tools in patient selection:
one is the SAFER test Link to Safer pdf
which helps to reduce the effect of having patients who are not really depressed but may have other CNS disorders.
Placebo effect is actually higher in clinic settings than in outside (at home) settings.
Upon the hiring of Marc de Somer MD, MBA, ScD, MPH, MSc, as Senior Vice President, Clinical Development and Safety...
he outlined his goals at Relmada...
"I am very excited to focus on maximizing our probability of success, defeating placebo response and excessive noise to demonstrate the true therapeutic signal with the necessary accuracy, precision and replicability. I look forward to working with the Relmada team, as we effectively conduct clinical trials to provide the highest quality of information and therapeutic value for patients, prescribers, payers and shareholders." said Dr. de Somer. "I look forward to contributing to de-risking development of REL-1017 in MDD, and additional indications and programs, as we build our pipeline and team."