Clinical-stage biopharma company Reunion Neuroscience has received the FDA’s clearance on its Investigational New Drug (IND) application to begin a Phase 2 study of RE104, a novel serotonergic psychedelic compound aimed at treating postpartum depression (PPD.) 

The company, which has recently gone private after listing on the NASDAQ as the clinical arm of former Field Trip, will commence its multicenter, randomized, double-blind, placebo-controlled “RECONNECT” trial.

The Phase 2 trial will evaluate the safety and efficacy of a single subcutaneous (SQ) dose of RE104 in adult female patients with PPD, one of the most common medical complications during and after pregnancy affecting 10-15% of patients and their families in the U.S.

Following a “successful Phase 1 adult healthy volunteer study" conducted earlier in Australia this 2023, the new trial would begin sometime within Q4 2023 with an expected data readout date in late 2024.

Women who have PPD experience significant changes in mood, appetite and …

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