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Ensysce Biosciences
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PF614 is a novel trypsin activated abuse protection (TAAP) prodrug of oxycodone. It is being evaluated in phase 2 clinical trials for the treatment of severe and/or chronic pain.


Lead Product(s): PF614

Therapeutic Area: Neurology Product Name: PF614

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 31, 2024

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The financing will support the completion of a time of onset study and regulatory milestones for company's lead product, PF614, a novel trypsin activated abuse protection (TAAP) prodrug of oxycodone, being studied as chronic pain analgesic.


Lead Product(s): Oxycodone Prodrug

Therapeutic Area: Neurology Product Name: PF614

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $1.7 million Upfront Cash: Undisclosed

Deal Type: Private Placement October 24, 2023

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PF614 is a chemically modified opioid product that requires initial metabolic transformation by trypsin in the small intestine for activation to be able to relieve severe pain in patients who require an opioid-level analgesic.


Lead Product(s): Oxycodone Prodrug

Therapeutic Area: Neurology Product Name: PF614

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 09, 2023

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PF614-MPAR (oxycodone prodrug) binds and inhibits adenylyl-cyclase and hyperpolarisation of neurons, and decreased excitability, thus reduces severe pain. It is the first opioid drug product that has both abuse deterrent properties as well as overdose protection.


Lead Product(s): Oxycodone Prodrug,Nafamostat

Therapeutic Area: Neurology Product Name: PF614-MPAR

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 14, 2023

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PF614-MPAR (oxycodone prodrug) binds and inhibits adenylyl-cyclase and hyperpolarisation of neurons, and decreased excitability, thus reduces severe pain. It is the first opioid drug product that has both abuse deterrent properties as well as overdose protection.


Lead Product(s): Oxycodone Prodrug,Nafamostat

Therapeutic Area: Neurology Product Name: PF614-MPAR

Highest Development Status: Phase IProduct Type: Small molecule

Recipient: Quotient Sciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2023

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PF614 is a TAAP (Trypsin Activated Abuse Protection) prodrug of oxycodone designed to reduce abuse of this opioid pain medication. PF614 requires exposure to trypsin, which safely turns ‘on' the release of oxycodone.


Lead Product(s): Oxycodone Prodrug

Therapeutic Area: Psychiatry/Psychology Product Name: PF614

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 20, 2022

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PF614 is a novel TAAP prodrug of oxycodone. PF614 uses the Ensysce TAAP technology and requires exposure to endogenous human trypsin in the intestines to trigger a two-step activation process to release active dose levels of oxycodone that is then absorbed systemically.


Lead Product(s): Oxycodone Prodrug

Therapeutic Area: Psychiatry/Psychology Product Name: PF614

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 28, 2022

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Details:

PF614-MPAR (oxycodone prodrug) is a novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose. This partnership serves as validation of the mission and ultimately the platforms.


Lead Product(s): Oxycodone Prodrug,Nafamostat

Therapeutic Area: Neurology Product Name: PF614-MPAR

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Quotient Sciences

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership August 31, 2022

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The Part A of the trial evaluated three dose levels of PF614 showed positive review from the Phase 1b tria, independent Safety Review Committee allowed the trial to proceed to the next dose level.


Lead Product(s): Oxycodone Prodrug,Nafamostat,Naltrexone Hydrochloride

Therapeutic Area: Psychiatry/Psychology Product Name: PRF06104

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 04, 2022

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Details:

PF614-MPAR™ is designed as an extended-release oxycodone prodrug with both trypsin-activated abuse protection (TAAP) and overdose protection through multi-pill abuse resistance (MPAR™) technology.


Lead Product(s): PF614

Therapeutic Area: Psychiatry/Psychology Product Name: PF614-MPAR

Highest Development Status: IND EnablingProduct Type: Small molecule

Partner/Sponsor/Collaborator: National Institute on Drug Abuse

Deal Size: $8.0 million Upfront Cash: Undisclosed

Deal Type: Funding July 08, 2021

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