India Pharma Outlook Team | Friday, 26 July 2024
Neuroscience Inc., a company focused on advancing in neuroscience, revealed that the initial patient has received medication in the RECONNECT phase 2 trial of RE104 for postpartum depression (PPD) treatment. RE104 was created with the intention of being a quick-acting and safe treatment option in a single dose for individuals with mental health disorders, such as PPD, that are often overlooked.
“Dosing the first patient in our RECONNECT phase 2 trial represents an important step forward in our mission of improving the lives of patients and families impacted by PPD,” said Greg Mayes, president and chief executive officer of Reunion. “There is a clear need for fast-acting, single-dose treatments with durable efficacy for PPD patients. Reunion is committed to serving not only the unmet need in PPD, but also the broader community affected by mental health disorders through its development programmes.”
The second phase of the RECONNECT clinical trial, identified as NCT06342310, is a study conducted at multiple centers. It is a double-blind, randomized trial comparing different doses of RE104 given as a single subcutaneous injection to adult female patients suffering from moderate-to-severe PPD. The main focus of the study is the difference in total score on the MADRS scale, which measures depression severity over 10 items and is rated by clinicians, from the start to Day 7. Other important factors to consider are the fluctuation in overall MADRS score at Day 1, 14, and 28 compared to the baseline, the response to MADRS with a 50% decrease in symptoms, achieving MADRS remission with a score of less than 10, and ensuring safety and tolerability.