Fludase (oplunofusp) / Ansun Biopharma - LARVOL DELTA

Sialidase fusion protein protects against influenza infection in a cigarette smoke-induced model of COPD. (PubMed, Mucosal Immunol) - "Upon reinfection, mice treated with DAS181 showed activated and protective memory response in the lungs. Collectively, we show that this sialidase fusion protein promotes a beneficial immunomodulatory reaction in the lungs, supporting a new IFV-A therapeutic option for at-risk smokers."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Inflammation • Influenza • Pulmonary Disease • Respiratory Diseases

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (clinicaltrials.gov) - P3 | N=274 | Recruiting | Sponsor: Ansun Biopharma, Inc. | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Dec 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Respiratory Diseases

Inhibiting influenza virus transmission using a broadly acting neuraminidase that targets host sialic acids in the upper respiratory tract. (PubMed, mBio) - "These insights support the potential of broadly acting neuraminidases as therapeutic agents capable of restraining viral transmission in vivo. Our study unveils intricate virus-host interactions during shedding, highlighting the necessity to develop innovative strategies to effectively target transmission."

Journal • Infectious Disease • Influenza • Pneumococcal Infections • Pneumonia • Respiratory Diseases

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (clinicaltrials.gov) - P3 | N=274 | Recruiting | Sponsor: Ansun Biopharma, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

Respiratory viral infections in the immunocompromised. (PubMed, Curr Opin Pulm Med) - "Several new antiviral agents, including combination therapy of oseltamivir as well as baloxavir for influenza, fusion and nucleoprotein inhibitors for RSV, DAS181 for PIV and brincidofovir for adenovirus, hold promise to speed clearance of the virus, improve clinical outcomes and reduce the risk of resistance emergence."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (clinicaltrials.gov) - P3; N=274; Recruiting; Sponsor: Ansun Biopharma, Inc.; Trial primary completion date: Apr 2021 ➔ Dec 2023

Clinical • Trial primary completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

Novel Treatment of Infant With COVID-19 With the Sialidase Fusion Protein, DAS181. (PubMed, Pediatr Infect Dis J) - "Therapy was well tolerated, and the patient had minimal side effects. The patient's respiratory distress and positive viral polymerase chain reaction rapidly resolved after initiation of therapy."

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

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (clinicaltrials.gov) - P3; N=274; Recruiting; Sponsor: Ansun Biopharma, Inc.; Trial completion date: Dec 2021 ➔ Dec 2023

Clinical • Trial completion date • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor

DAS181 Treatment of Severe Lower Respiratory Tract Parainfluenza Virus Infection in Immunocompromised Patients: A Phase 2 Randomized, Placebo-Controlled Study. (PubMed, Clin Infect Dis) - "The primary endpoint was not met, but post-hoc analysis of the RTRA component suggests DAS181 may have clinical activity in improving oxygenation in select severely immunocompromised patients with PIV LRTI who are not on mechanical ventilation."

Clinical • Journal • P2 data • Infectious Disease • Respiratory Diseases • Transplantation

Resolution of Coronavirus Disease 2019 Infection and Pulmonary Pathology With Nebulized DAS181: A Pilot Study. (PubMed, Crit Care Explor) - P=N/A | "Inhalation of DAS181 was well tolerated and potential clinical benefit of DAS181 on hypoxic coronavirus disease 2019 is the reduction of supplemental oxygen need. Efficacy and safety, including pharmacokinetics and viral studies of DAS181 in severe, hypoxic coronavirus disease 2019, should be examined by a double-blind, randomized controlled study."

Clinical • Journal • Critical care • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

DAS181 for STOP COVID-19 (clinicaltrials.gov) - P2/3; N=0; Withdrawn; Sponsor: Ansun Biopharma, Inc.; N=82 ➔ 0; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Jun 2020 ➔ Sep 2020

Clinical • Enrollment change • Trial primary completion date • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Trial Assessing Antiviral Drug DAS181 Against COVID-19 Begins Enrolling Patients (Technology Networks) - "Keck Medicine of USC physicians are enrolling patients as part of an international clinical trial to evaluate the safety and efficacy of an antiviral drug, DAS181, as a possible treatment for hospitalized patients with severe COVID-19....This Phase 3 clinical trial is a double-blind, randomized controlled study. Half the participants will receive DAS181 through a nebulizer that delivers a vaporized form of the medication to the lungs and half will receive a placebo."

Enrollment status • Infectious Disease • Novel Coronavirus Disease

STOP Flu: DAS181 for Patients With Severe Hospitalized Flu and SAD-RVs (COVID-19) (clinicaltrials.gov) - P2b; N=280; Not yet recruiting; Sponsor: Ansun Biopharma, Inc.; Initiation date: Apr 2020 ➔ Jul 2020

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease

Worldwide Trends on COVID-19 Research After the Declaration of COVID-19 Pandemic (clinicaltrials.gov) - P; N=200; Not yet recruiting; Sponsor: Qassim University

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease

DAS181 for STOP COVID-19 (clinicaltrials.gov) - P2/3; N=82; Not yet recruiting; Sponsor: Ansun Biopharma, Inc.; Trial completion date: Jul 2020 ➔ Oct 2020

Clinical • Trial completion date • Novel Coronavirus Disease

New antiviral approaches for human parainfluenza: Inhibiting the haemagglutinin-neuraminidase. (PubMed, Antiviral Res) - "Although many HN inhibitors have been developed and evaluated as anti-hPIV agents, currently only a host-directed therapy (DAS181) has succeeded in phase II clinical drug trials. Hence, the review concludes with future considerations for targeting the specific function(s) of hPIV HN and suggestions for antiviral drug design."

Journal • Review • Immunology • Infectious Disease • Respiratory Diseases

DAS181 for Severe COVID-19: Compassionate Use (clinicaltrials.gov) - P=N/A; N=4; Completed; Sponsor: Renmin Hospital of Wuhan University; Recruiting ➔ Completed

Trial completion

STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects STOP PIV - DAS181 en fase III en infección de vías respiratorias inferiores por VPI en sujetos inmunodeprimidos (clinicaltrialsregister.eu) - P3; N=132; Ongoing; Sponsor: Ansun Biopharma, Inc.

Clinical • New P3 trial • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Multiple Myeloma • Oncology • Respiratory Diseases • PCR

DAS181 for STOP COVID-19 (clinicaltrials.gov) - P2/3; N=82; Not yet recruiting; Sponsor: Ansun Biopharma, Inc.

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

Ansun Biopharma announces the positive results of an investigator-initiated trial on a new treatment for Covid-19 (PRNewswire) - "Ansun Biopharma, Inc....today announced preliminary data from an investigator-initiated trial of DAS181....'First two patients no longer needed supplemental oxygen and presented stabilized vital signs, increased oxygen saturation, and resolution of infiltrates....The third patient, who had been a persistent carrier of SARS-CoV-2 for more than 33 days, was completely virus-free'....Ansun also announced the start of another randomized, double-blind, placebo-controlled proof of concept trial to determine the safety and efficacy of DAS181 in the treatment of severe COVID-19 pneumonia. This two-step trial will initially recruit approximately 20 patients....The company plans to increase registrations after an interim review of the data."

Clinical data • New trial

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study (clinicaltrials.gov) - P3; N=250; Recruiting; Sponsor: Ansun Biopharma, Inc.; N=132 ➔ 250

Clinical • Enrollment change

DAS181 for COVID-19: Compassionate Use (clinicaltrials.gov) - P=N/A; N=4; Recruiting; Sponsor: Renmin Hospital of Wuhan University

New trial

STOP Flu: Sialidase Treatment of Patients With Influenza (clinicaltrials.gov) - P2b; N=280; Not yet recruiting; Sponsor: Ansun Biopharma, Inc.

Clinical • New P2b trial

Treating Influenza Infection, From Now and Into the Future. (PubMed, Front Immunol) - "New therapies which target highly conserved features of IV such as antibodies to the stem region of hemagglutinin or the IV RNA polymerase inhibitor: Favipiravir are currently in clinical trials...Anti-inflammatory drugs such as etanercept, statins or cyclooxygenase enzyme 2 inhibitors may temper IV induced inflammation, demonstrating the possibility of repurposing these drugs as single or adjunct therapies for IV infection...The neuraminidase mimic Fludase cleaves sialic acid receptors from the epithelium to inhibit IV entry to cells. While type III interferons activate an antiviral gene program in epithelial cells with minimal perturbation to the IV specific immune response. This review discusses the above-mentioned candidate anti-IV therapeutics and others at the preclinical and clinical trial stage."

Journal • Review

STOP PIV - Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (clinicaltrials.gov) - P3; N=132; Recruiting; Sponsor: Ansun Biopharma, Inc.; Active, not recruiting ➔ Recruiting

Clinical • Enrollment open