Ensysce Biosciences has received a $14m multi-year grant from the National Institutes of Health (NIH) and the National Institute on Drug Abuse (NIDA) for clinical development of PF614-MPAR, a novel opioid with overdose protection.
PF614-MPAR, an abuse-deterrent opioid, earned Breakthrough Therapy designation from the US Food and Drug Administration (FDA) in January 2024.
The funding, available over approximately three years, will facilitate the completion of the Phase 1b clinical trial, PF614-MPAR-102.
The latest trial builds on the findings from the PF614-MPAR-101 study, the initial trial to confirm the overdose protection capabilities of the Multi-Pill Abuse Resistance (MPAR) platform.
Together, these studies are expected to establish PF614-MPAR as the first opioid product with oral overdose protection.
Concurrently, Ensysce Biosciences received Investigational Review Board (IRB) approval for the PF614-MPAR-102 trial.
The study will be conducted in collaboration with Quotient Sciences using its Translational Pharmaceutics platform.
The latest federal grant takes the total amount raised to $40m. Previously, Ensysce Biosciences received $14.5m in 2018 to develop the opioid.
In 2019, the pharmaceutical firm secured $9.3m from NIDA to continue developing PF614-MPAR.
Ensysce Biosciences CEO Lynn Kirkpatrick said: “This non-dilutive award by NIDA is another meaningful vote of support by the federal government for the development of this novel class of opioids with overdose protection.
“Our initial Phase 1 study of PF614-MPAR demonstrated this approach to treat pain provides protection from taking too many pills orally.
“With this funding, adding to the two prior grants of over $26m for the initial work on the MPAR and opioid use disorder (OUD) programmes, Ensysce intends to quickly drive PF614-MPAR through clinical development to make its benefits available in a large market where we believe unmet need is high.”
Ensysce Biosciences is a clinical-stage firm focused on creating new solutions for severe pain relief while minimising opioid abuse and overdose risks.
Its PF614-MPAR is engineered to deliver effective pain relief at prescribed doses while reducing the risk of accidental or intentional overdose.
The platform will support the development of a new class of treatments for severe pain.
The pharmaceutical firm has currently two new opioids in clinical development. In addition, the company will use the MPAR technology to enhance drug safety beyond just opioids.
