EDP-235 / Enanta Pharma - LARVOL DELTA

SPRINT: A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19 (clinicaltrials.gov) - P2 | N=231 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

The small molecule inhibitor of SARS-CoV-2 3CLpro EDP-235 prevents viral replication and transmission in vivo. (PubMed, Nat Commun) - "EDP-235 maintains potency against variants bearing mutations associated with nirmatrelvir resistance. Furthermore, SARS-CoV-2 contact transmission does not occur when naïve ferrets are co-housed with infected, EDP-235-treated ferrets. Collectively, these results demonstrate that EDP-235 is a broad-spectrum coronavirus inhibitor with efficacy in animal models of primary infection and transmission."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy and safety of EDP-235 in non-hospitalised adults with mild or moderate COVID-19: results from the phase 2 SPRINT study (ECCMID 2024) - No abstract available

Clinical • P2 data • Infectious Disease • Novel Coronavirus Disease

On the origins of SARS-CoV-2 main protease inhibitors. (PubMed, RSC Med Chem) - "In less than 3 years of research, 4 inhibitors of SARS-CoV-2-M have actually been authorized for COVID-19 treatment (nirmatrelvir, ensitrelvir, leritrelvir and simnotrelvir) and more such as EDP-235, FB-2001 and STI-1558/Olgotrelvir or five undisclosed compounds (CDI-988, ASC11, ALG-097558, QLS1128 and H-10517) are undergoing clinical trials. Since many series of covalent SARS-CoV-2-M inhibitors owe some of their origins to previous work on other proteases, we first provided a description of various inhibitors of cysteine-bearing human caspase-1 or cathepsin K, as well as inhibitors of serine proteases such as human dipeptidyl peptidase-4 or the hepatitis C protein complex NS3/4A. This is then followed by a description of the results of the approaches adopted (repurposing, structure-based and high throughput screening) to discover coronavirus main protease inhibitors."

Journal • Review • Hepatitis C • Hepatology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • CASP1 • CTSK • SPECC1

Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects. (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Enanta Pharmaceuticals, Inc | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

EDP-235, a potent, once-daily, oral antiviral, demonstrates potential for treatment and prevention of long COVID (ECCMID 2023) - No abstract available

Novel Coronavirus Disease

SPRINT: A Study to Evaluate EDP-235 in Non-hospitalized Adults With COVID-19 (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P1 trial • Infectious Disease • Novel Coronavirus Disease

Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects. (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Enanta Pharmaceuticals, Inc

New P1 trial • Infectious Disease • Novel Coronavirus Disease

EDP-235, A Potent and Once-daily Oral Antiviral, Demonstrates Excellent Penetration into Macrophages and Monocytes, with the Potential for Mitigation of Cytokine Storm in High-Risk COVID-19 Patients (IDWeek 2022) - No abstract available

Clinical • Cytokine storm • Infectious Disease • Novel Coronavirus Disease

EDP-235, A Potent and Once-daily Oral Antiviral, Demonstrates Excellent Penetration into Macrophages and Monocytes, with the Potential for Mitigation of Cytokine Storm in High-Risk COVID-19 Patients (IDWeek 2022) - No abstract available

Clinical • Cytokine storm • Infectious Disease • Novel Coronavirus Disease

A Study of EDP-235 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Enanta Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Molecular Basis for Antiviral Action of EDP-235: A Potent and Selective SARS-CoV-2 3CLpro Inhibitor for the Treatment of Covid 19. (PubMed, FASEB J) - "In summary, EDP-235 acts as a slow-onset, slow-reversible, substrate-competitive inhibitor of SARS-CoV-2 3CLpro. The outstanding preclinical profile of EDP-235 supports its further evaluation as an oral therapeutic for the management of COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"The opening for $ENTA's EDP-235 just got wider." (@DewDiligence)

A Study of EDP-235 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Enanta Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study of EDP-235 in Healthy Subjects (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Enanta Pharmaceuticals

New P1 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Enanta Pharmaceuticals reports financial results for its fiscal second quarter ended March 31, 2020 with webcast and conference Call today at 4:30 p.m. ET (Enanta Press Release) - "Pipeline Programs and Near-term Milestones: Advance efforts for discovery of direct-acting antiviral compounds for SARS-CoV-2."

New molecule • Infectious Disease • Novel Coronavirus Disease