Reunion Neuroscience’s psychedelic drug is advancing to Phase III trials after it met the primary endpoint in a Phase II post-partum depression (PPD) trial.
In the RECONNECT trial (NCT06342310), the majority of patients treated with 30mg RE104 saw a statistically significant reduction of 23.0 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score after seven days, as compared to a reduction of 17.2 points in patients treated in the active control arm with a 1.5mg dose of RE104.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Of those who received the 30mg dose, 77.1% demonstrated at least a 50% improvement from baseline MADRS total score, as compared to 61.6% of patients who received active control, with benefit remaining for 28 days.
The study also found 71.4% of patients treated with RE104 30mg were in remission after seven days, compared with 41% of patients who received the control, with this maintained at up to 28 days.
The therapy was well tolerated, with a safety profile consistent with previously reported Phase I safety data with RE104 and other psychedelic agents. There were also no serious treatment-emergent adverse events (SAEs), and no evidence of treatment-emergent suicidal ideation or behaviour in either arm.
Based on the data from RECONNECT, Reunion plans to advance its psychedelic into a Phase III trial for the treatment of PPD in 2026.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataDr. Camille Hoffman, professor of maternal foetal medicine at the University of Colorado School of Medicine, said: “Our current treatment options are limited, and we need therapies that help our patients recover rapidly during such a dynamic time of life.
“The results of the RECONNECT trial are encouraging and provide hope that this therapy may help more mothers overcome the burden of PPD and find their way back to themselves and their families for the moments that matter most.”
Reunion also ran a clinical lactation study, with preliminary results showing the total amount of metabolites observed in the breastmilk represents less than 0.1% of the 30mg RE104 administered to the mother, which is below the level that might potentially cause risk to the infant. This is with the hope that mothers who wish to return to breastfeeding after RE104 treatment will be able to do so with limited interruption.
Reunion is also getting ready to initiate the Phase II REKINDLE (NCT07002034) trial of RE104 in patients with adjustment disorder related to cancer and other medical illnesses in Q3 2025 and plans to commence a Phase II trial in a third undisclosed significant mental health indication in Q1 2026.
RE104 is a short-acting prodrug of a psychedelic compound called 4-OH-DiPT, which is similar to psilocybin.
An analysis by GlobalData identified a 500% growth in partnership deals involving psychedelic drugs between 2019 and 2023, with more than 40 partnerships established since 2019.
GlobalData is the parent company of Clinical Trials Arena.
Companies investigating psychedelics are looking into their trial designs after Lykos’ MDMA based therapy was refused for approval by the US Food and Drug Administration in 2024. While full details for the refusal were not disclosed, experts say that it could have been due to the placebo comparator or functional unblinding.
