Shares of small-cap biotech Relmada Therapeutics Inc (NASDAQ: RLMD) were soaring to their highest level since 2015 following a positive clinical readout from the company.
New York-based Relmada released top-line data from a Phase 2 study that evaluated its REL-1017-202, chemically dextromethadone, in 25mg once a day and 50mg daily doses as an adjunctive treatment in patients with treatment-resistant depression, or TRD.
The 62 subjects enrolled in the study had an average age of 49.2 years, an average Hamilton Depression Rating Scale score of 25.3 and an average Montgomery-Asberg Depression Rating Scale score of 34, reflecting severe depression. They experienced statistically significant improvement of their depression compared to the placebo group on all efficacy measures, according to Relmada.
The subjects were administered either 25mg or 100mg of REL-1017 for seven days and discharged at day seven, with efficacy measured on Days two, four and seven during the dosing and on day 14, a week after treatment was discontinued.
Continued improvement was apparent on day four in both dosage groups and continued through days seven and 14, according to the company.
The midstage study confirmed the favorable safety and tolerability profile of REL-1017 observed in the Phase 1 studies, the company said.
Safety, Simplicity A Differentiator?
TRD is a widely prevalent disorder. About 300 million people worldwide have major depressive disorder, which affects functioning as well as the quality of life. At least one-third of this group is treatment-resistant.
Several other biopharma companies have TRD investigational assets in various stages of clinical development.
"These results confirm for the first time in severely depressed patients that REL-1017 is showing rapid, statistically and clinically meaningful antidepressant activity, in conjunction with a favorable tolerability and safety profile, and a simple oral administration regime," Relmada CEO Sergio Traversa said in a statement.
The company said it is looking forward to discussing next steps with the FDA to enable it to rapidly advance the clinical development of REL-1017. The drug is an NMDA receptor antagonist and on the same binding site as ketamine, but has shown none of ketamine's psychotomimetic side effects.
At last check, Relmada shares were galloping 166.10% to $29.79 in pre-market trading, their highest level since late-September 2015.
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