nafamostat / Ensysce Biosciences - LARVOL DELTA

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Ensysce Biosciences | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Ensysce Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Ensysce Biosciences | Trial completion date: Jun 2026 ➔ Dec 2025 | Trial primary completion date: Jun 2026 ➔ Sep 2025

Trial completion date • Trial primary completion date

Oral Nafamostat in Healthy Volunteers (NAF-101) (clinicaltrials.gov) - P1 | N=17 | Completed | Sponsor: Ensysce Biosciences | Phase classification: P1b ➔ P1

Phase classification

Single and Multi-Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Ensysce Biosciences

New P1 trial

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=111 | Completed | Sponsor: Ensysce Biosciences | Active, not recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Apr 2023

Trial completion • Trial completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=111 | Active, not recruiting | Sponsor: Ensysce Biosciences | Recruiting ➔ Active, not recruiting | N=64 ➔ 111 | Trial completion date: Feb 2023 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Ensysce Biosciences | Trial completion date: Nov 2022 ➔ Feb 2023 | Trial primary completion date: Nov 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Ensysce Biosciences | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2022 ➔ Nov 2022 | Trial primary completion date: Apr 2022 ➔ Nov 2022

Enrollment open • Trial completion date • Trial primary completion date

MPAR-101: Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (clinicaltrials.gov) - P1; N=64; Not yet recruiting; Sponsor: Ensysce Biosciences

Clinical • New P1 trial

Oral Nafamostat in Healthy Volunteers (clinicaltrials.gov) - P1b; N=17; Completed; Sponsor: Ensysce Biosciences; Not yet recruiting ➔ Completed; Trial completion date: Oct 2020 ➔ May 2021; Trial primary completion date: Aug 2020 ➔ Nov 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date

[VIRTUAL] SARS-CoV-2 Infection and ENaC Activity Are Both Inhibited by Nafamostat Applied Apically on Human Airway Epithelial Cells in Air-Liquid Interface Culture (ATS 2021) - "ENaC activity in HAEC was measured as amiloride-dependent decrease in short-circuit current. 1. No detrimental effects of NF up to 20 μM applied to surface of HAEC. 2."

Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • TMPRSS2

Ensysce Biosciences’ Covistat Subsidiary 'At Home Coronavirus Pill' Commencing to Phase 2 clinical development (GlobeNewswire) - "Covistat to present pre-clinical data at American Thoracic Society annual meeting, May 14-19, 2021....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....Covistat is currently exploring the use of oral nafamostat for treatment of COVID-19 and expected to launch a Phase 2 trial during the second half of 2021."

New P2 trial • Preclinical • Infectious Disease • Novel Coronavirus Disease

COVISTAT, a Subsidiary of Ensysce Biosciences Inc, a California Based Company With a Mission to Solve the Opioid Crisis, Is Commencing Phase 1 Study of Novel COVID-19 Treatment (Businesswire) - "COVISTAT Inc. and its parent company Ensysce, received IND allowance and today initiated a Phase 1 clinical trial of oral nafamostat in healthy volunteers....The Phase 1 trial at the Arizona Research Center...is examining nafamostat as an oral solution....The outcome will be to identify a dose and schedule for a subsequent Phase 2 trial....There is strong interest from other major medical centers in the US, Europe and Asia to conduct Phase 2 trials....COVISTAT also has plans to explore intra-nasal and inhaled routes of administration against COVID-19."

IND • Trial status • Infectious Disease • Novel Coronavirus Disease

CSIR seeks regulatory nod for clinical trials using combination of antivirals and HDTs against COVID-19 (ExpressPharma) - "The Council of Scientific & Industrial Research (CSIR), in collaboration with Laxai Life Sciences Hyderabad, has sought regulatory approval to undertake four-arm randomised controlled phase III clinical trial. The design principle of the study is...determine safety and efficacy of the three combination drugs (Favipiravir+Colchicine, Umifenovir+Colchicine and Nafamostat+5-ALA) and a control arm with the standard of care in COVID-19 patients. The clinical trial named MUCOVIN, to be carried out in the partnership with Medanta Medicity..."

Cytokine storm • New P3 trial • Infectious Disease • Novel Coronavirus Disease

Oral Nafamostat in Healthy Volunteers (clinicaltrials.gov) - P1b; N=20; Not yet recruiting; Sponsor: Ensysce Biosciences

Clinical • New P1 trial