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Relmada Hopes Open-Label Efficacy, Safety Bolster Profile Of Depression Candidate

 
• By Joseph Haas

With a pair of Phase III setbacks due to high placebo response, Relmada reports positive efficacy and safety data from an open-label trial while awaiting data from two ongoing pivotal studies for REL-1017, an NMDA antagonist.

DEPRESSION miserable depressed , Depression and its consequences, Depressed emotions concept , alone in depression - Image

Ahead of a pair of pivotal Phase III trial readouts expected in 2024, Relmada Therapeutics, Inc. released data from an open-label Phase III trial of REL-1017 on 20 September which it said showed clinically meaningful and sustained improvements in depression symptoms and associated functional impairment while continuing to support a safety profile that might give the NMDA antagonist an edge in the competitive depression space.

Key Takeaways

    • After two Phase III failures – which the company attributes to high placebo response –...

    • The drug’s prospects took a hit last October when the pivotal Phase III RELIANCE-III study failed to hit its primary endpoint of improvement from baseline on the Montgomery-Asberg Depression Rating...

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