Ensysce Biosciences is a clinical-stage biotech company based in San Diego, CA that has a mission to revolutionize the safety and oral delivery of medicines for areas of high unmet need in pain management. Ensysce Biosciences has developed two proprietary anti-abuse and anti-overdose technology platforms, Trypsin-Activated Abuse Protection (TAAP™) tamper-proof technology and Multi-Pill Abuse Resistance (MPAR™) technology, to effectively control the way a drug is turned on or turned off when consumed.
Quotient Sciences was approached by Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences, to help overcome formulation challenges with the development of a modified release product for PF614-MPAR, the company's leading product intended for the treatment of severe pain. After speaking with a non-integrated, traditional contract drug development and manufacturing organization (CDMO) and enquiring about the timelines for clinical trial manufacturing (CTM) of a single prototype, Dr. Kirkpatrick quickly realized that it would take years to arrive at a successful MR formulation.
Dr. Kirkpatrick recognized that Quotient Sciences' Translational Pharmaceutics platform, with its ability to integrate formulation development, real-time clinical manufacturing, and clinical dosing under a single organization, would provide her with the flexibility to test multiple prototypes under a single clinical protocol and arrive at successful formulation in just twelve months.
"I knew that traditional manufacture and release would make it impossible for us to clinically determine the correct nafamostat component of our drug product. Quotient Sciences explained to me how their Translational Pharmaceutics platform could reduce our development timeline by defining a design space for ER release rate, ER/IR ratio, and nafamostat dose. Additionally, they could integrate real-time adaptive manufacturing with clinical testing to rapidly test the variables within the design space and optimize the nafamostat formulation.”
Dr. Lynn Kirkpatrick, CEO of Ensysce Biosciences