After flunking two phase 3 trials, Relmada Therapeutics has turned over the open-label card for its depression med, providing the first bit of optimism in months, if not years, for the central-nervous-system-focused biotech.
The company says patients with major depressive disorder treated with REL-1017 for up to one year “experienced rapid, clinically meaningful, and sustained improvements in depressive symptoms,” according to a release Wednesday. The critical caveat: There’s no placebo comparison this time around.
The open-label trial, Study 310, included 423 rollover patients from previously blinded phase 3 studies and 203 newly enrolled patients. At the time the study concluded, 418 patients had been treated for at least six months and 118 for at least one year.
Relmada says that among the new patients added, the average score on a scale that assesses the severity of depressive episodes fell by nearly 20 points at the three- and six-month points and by 22.5 points at the one-year mark. The average Montgomery–Åsberg Depression Rating Scale (MADRS) score at baseline was 33.8.
The company also reported that more than 50% of treated patients notched a clinical response at the end of the first month, measured as at least a 50% reduction in MADRS total score. More than half of the newly enrolled patients reported being in clinical remission after one year of treatment. Relmada also reported improvements among these patients in functional impairment and anxiety.
All adverse events related to treatment occurred in less than 5% of patients, with the most common side effects being headaches, nausea and dizziness. Discontinuation due to adverse events occurred in about 3% of patients.
Investors rewarded the company’s persistence, with shares up more than 10% shortly after the market opened, from $2.79 per share to $3.08. Data from the rollover population will be reported later.
The data are a glimmer of hope for Relmada and REL-1017 after prior phase 3 trial failures were attributed to an “unplausible placebo response” at a number of high enrolling sites. The company launched an additional trial, Study 304, to help offset the disappointing data in the previous trials. Relmada reported in its second-quarter earnings update that screening has begun in that new trial.