Bionomics (ASX:BNO) has announced a Memorandum of Understanding with EmpathBio, the wholly-owned subsidiary of German-based CNS clinical development company atai Life Sciences.
The MoU will see the companies collectively explore a combination drug treatment regimen including Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01.
They 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. It has been granted Fast Track designation by the US FDA for the treatment of PTSD and other trauma-related and stress-related disorders. A new solid dose formulation of BNC210 has been developed and will be used in a Phase 2 study in PTSD that is projected to commence in the mid-2021.
EmpathBio’s EMP-01 is one of 11 programs in atai’s pipeline. EmpathBio specifically focuses on developing MDMA derivatives that may permit the entactogenic effects of MDMA to be separated from some of the known adverse effects. If successful, such an approach could help minimize some of the transient physiological changes caused by MDMA, potentially expanding the pool of PTSD patients who will be medically eligible for the therapy.
Bionomics’ executive chairman, Dr Errol De Souza, said, “We are delighted to have entered into this exploratory collaboration with EmpathBio, which is looking at novel approaches to the treatment of PTSD. We consider that EMP-01, a derivative of MDMA, being developed by EmpathBio could be a very interesting treatment regimen when combined with BNC210 for the treatment of PTSD.
"Our entry into a Memorandum of Understanding with EmpathBio has drawn together an initial collaborative framework of preclinical studies, in which we can develop some deeply informed views about the possibility of a combination treatment regimen warranting clinical evaluation at a later date.”
EmpathBio CEO, Glenn Short, said “We look forward to collaborating with Bionomics and the possibility of expanding the development potential of EMP-01 in combination with BNC210. Current clinical trials for MDMA carry a significant psychotherapy protocol which we could possibly re-evaluate with Bionomics’ BNC210 to reduce some of the unwanted side effects and improve patient outcomes."