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Details:

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: Ensysce Biosciences

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 25, 2023

Details:

Niyad (a lyophilized formulation of nafamostat), an investigational broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, mucus clearing and potential anti-viral activities, towards an FDA approval.


Lead Product(s): Nafamostat

Therapeutic Area: Hematology Product Name: Niyad

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 03, 2023

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Details:

The net proceeds will be used to advance Niyad (nafamostat), an investigational broad-spectrum serine protease inhibitor with anticoagulant, anti-inflammatory, mucus clearing and potential anti-viral activities, towards an FDA approval.


Lead Product(s): Nafamostat

Therapeutic Area: Hematology Product Name: Niyad

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $26.3 million Upfront Cash: Undisclosed

Deal Type: Private Placement July 21, 2023

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Details:

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) 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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Details:

Study results demonstrate that nafamostat had similar efficacy as citrate, while providing lower toxicity and lower costs to the hospital over standard citrate anticoagulation.


Lead Product(s): Nafamostat

Therapeutic Area: Hematology Product Name: Niyad

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 March 29, 2022

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Details:

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:

The agreement to acquire Lowell will also include LTX-608, Lowell's proprietary nafamostat formulation for direct IV infusion being developed for the treatment of acute respiratory distress syndrome (ARDS) and disseminated intravascular coagulation (DIC).


Lead Product(s): Nafamostat

Therapeutic Area: Hematology Product Name: LTX-608

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: AcelRx Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition November 15, 2021

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Details:

Covistat will present a summary of its findings that it believes demonstrate the ability of nafamostat, delivered to airways, to inhibit SARS-CoV-2 viral infection and increase mucocilliary clearance in the human airway.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

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 May 07, 2021

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Details:

DS-2319 contains nafamostat mesilate that has been formulated in an inhalation dosage form. It is being studied for treating COVID-19 since it has been shown to block membrane fusion between the viral envelope that causes COVID-19 and the host plasma cell membrane.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: DS-2319

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 March 30, 2021

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Details:

The drug, Nafabeltan, will be administered to patients as part of the Australian government-led clinical study to find a COVID-19 treatment. The drug is currently used as a blood anticoagulant and acute pancreatitis treatment.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Nafabeltan

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 December 14, 2020

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Details:

The ultimate goal will be to evaluate if nafamostat mesylate (nafamostat), that has been shown to be an inhibitor of SARS-CoV-2 host cell entry through TMPRSS2, will be effective in preventing progression to acute respiratory failure, to due to COVID-19 infection.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

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 September 28, 2020

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Details:

Russia’s Drug Ministry approved of its clinical phase two trial design targeting some 100 seriously afflicted COVID-19 pneumonic patients there. The patients will be administered nafamostat for 10 days.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Nafabeltan

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 September 01, 2020

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Details:

Nafamostat works by affecting the body's own enzymes—not the virus, which is capable of mutating to evade treatments. Nafamostat blocks TMPRSS2, the enzyme that enables SARS-CoV-2's spike proteins to gain entry into cells.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Covistat

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition August 06, 2020

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Details:

Through the partnership, The University of Tokyo, RIKEN, Nichi-Iko and Daiichi Sankyo have reached a basic agreement on collaborative R&D on a Nafamostat inhalation formulation for the treatment of novel corona virus infection (COVID-19).


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: The University of Tokyo

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 08, 2020

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Details:

Nafamostat has shown promising data against SARS-CoV-2 virus in in vitro studies conducted by three independent groups of scientists in Europe, Japan and South Korea.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: UndisclosedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 01, 2020

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Details:

The goal is to evaluate if nafamostat mesylate (Nafamostat), a synthetic protease inhibitor will be effective in preventing or reducing the lethal outcome of COVID-19 infection.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 15, 2020

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  • Development Update

Details:

Researchers at the University of Tokyo found that Nafamostat can prevent fusion of the virus envelope with the host cell surface proteins at one tenth of the Camostat mesylate concentration required.


Lead Product(s): Nafamostat

Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

Highest Development Status: PreclinicalProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable March 31, 2020

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