Reunion Neuroscience Receives FDA Clearance On IND Application For Postpartum Depression Trial
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 sleep contributing to feelings of hopelessness, lack of concentration, loss of energy, poor self-esteem and maternal disinterest.
“Mental health conditions unfortunately remain the leading cause of pregnancy-related deaths,” says CEO Greg Mayes. “There are so few solutions for patients and families suffering from PPD, which has been shown to compromise childhood development and the family unit and can, in the worst cases, lead to serious harm for mother and risk to her child.”
The Reunion team is “committed to making a significant difference in improving outcomes in this patient population and other mental health disorders,” potentially providing a solution with a faster onset of action, greater efficacy after one dose, with limited interruption in breastfeeding and a faster return to daily activities.
One Compound, Multiple Patent Claims
Reunion’s lead asset is RE104, which it defines as “a proprietary, novel, serotonergic psychedelic compound” and “the only 4-OH-DiPT prodrug in clinical development.”
The company’s target is PPD, posing the compound could provide rapid symptom relief and durable efficacy.
RE104 is reportedly protected under U.S. patent No. 11,292,765 issued on April 5, 2022 (priority June 30, 2020), with claims for the composition of matter, methods of manufacturing, formulations and methods of use for a genus of hemiester tryptamines -including RE104- which could provide protection out to June 30, 2041.
Nonetheless, since at least March 2023 there’s been an ongoing legal battle among different biopharma companies on the compound’s creative ownership, including a lawsuit filed by Reunion against Mindset Pharma MSSTF claiming correction of inventorship in a patent application filed by the latter; as well as invention protection claims by private biotech Terran Biosciences, potentially covering very similar compounds.