Bionomics Limited announced that it has entered into a Memorandum of Understanding with EmpathBio Inc. (EmpathBio) atai Life Sciences (atai). Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01. The parties will explore whether the different mechanisms of action of EMP-01 and BNC210 may offer the potential for developing an improved treatment regimen for the treatment of Post-Traumatic Stress Disorder (PTSD). BNC210 is Bionomics' lead drug candidate, which has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of PTSD and other trauma-related and stress-related disorders. A new solid dose formulation of BNC210 has recently been developed and will be used in a Phase 2 study in PTSD, projected to commence in the middle of 2021. MDMA-assisted psychotherapy (two to three treatment sessions) has demonstrated significant symptom improvement in PTSD patients which continued at least 12 months post-treatment (Jerome et al., Psychopharmacology 237: 2485-2497, 2020). The FDA has granted a Breakthrough Therapy designation to MDMA-assisted psychotherapy, which is currently in Phase 3 trials being conducted by US not-for-profit organisation, the Multidisciplinary Association for Psychedelic Studies (MAPS). EmpathBio's EMP-01 is one of 11 programs in atai's pipeline. EmpathBio specifically focuses on developing MDMA derivatives that EmpathBio believes may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects. If successful, such an approach could help minimise some of the transient physiological changes caused by MDMA, potentially expanding the pool of PTSD patients who will be medically eligible for the therapy.