Relmada reports positive results from open-label trial of REL-1017 for major depressive disorder

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Relmada Therapeutics, a central-nervous-system-focused biotech company, has finally glimpsed a ray of optimism after facing setbacks in two phase 3 trials for its depression medication. The company has unveiled positive results from an open-label trial of its drug REM-1017, offering a glimmer of hope for both the biotech and its central-nervous-system-focused treatment.

According to the company’s recent release, patients diagnosed with major depressive disorder who received REM-1017 for up to one year “experienced rapid, clinically significant, and sustained improvements in depressive symptoms.” It’s important to note that this time, there was no placebo group for comparison.

The open-label trial, known as Study 310, comprised 423 patients who had previously participated in blinded phase 3 studies and 203 newly enrolled patients. When the study concluded, 418 patients had received treatment for at least six months, and 118 had received treatment for at least one year.

“These efficacy and safety results represent real-world potential outcomes for MDD patients when treated with REL-1017. The rapid and sustained therapeutic effects achieved with REL-1017 suggest the significant therapeutic potential of this promising late-stage product candidate as a mechanistically novel and differentiated treatment for MDD. The early magnitude and trajectory of clinical improvement remain consistent across all trials conducted to date. The long-term sustained clinical improvement, coupled with an extremely well-tolerated profile, adds to our enthusiasm for this agent as a potential therapeutic option for patients and prescribers.”

– Cedric O’Gorman, MD, Chief Medical Officer of Relmada

Among the newly enrolled patients, the average score on a scale measuring the severity of depressive episodes dropped by nearly 20 points at the three- and six-month marks and by 22.5 points after one year. The baseline average Montgomery–Åsberg Depression Rating Scale (MADRS) score was 33.8. The company also reported that more than half of the treated patients achieved a clinical response by the end of the first month, defined as a minimum 50% reduction in MADRS total score. Furthermore, over half of the newly enrolled patients reported clinical remission after one year of treatment. Relmada also observed improvements in functional impairment and reduced anxiety among these patients.

Regarding safety, adverse events linked to treatment occurred in less than 5% of patients, with common side effects being headaches, nausea, and dizziness. Discontinuation due to adverse events affected approximately 3% of patients.

Investors responded positively to these encouraging findings, driving the company’s shares up by over 10% shortly after the market opened, increasing from $2.79 per share to $3.08. Data from the rollover patient population will be disclosed at a later date.

These results represent a glimmer of hope for Relmada and its REM-1017 medication, especially after prior phase 3 trial failures were attributed to an “implausible placebo response” at several high-enrollment sites. To address these challenges, the company initiated Study 304, an additional trial, as part of its efforts to overcome the disappointing outcomes observed in previous trials. Relmada has already reported the commencement of screening for this new trial in its second-quarter earnings update.

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