DAS181 for Respiratory Infections

Recruiting at 27 trial locations

Overseen By Lana Ordonez

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Ansun Biopharma, Inc.

Must not be taking: Investigational drugs, Immunomodulating biologics

Disqualifiers: Hospice care, Severe sepsis, HIV-positive, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

274 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, DAS181, for individuals with weakened immune systems facing respiratory infections like parainfluenza or severe COVID-19. The goal is to determine if DAS181 can improve their condition by targeting these specific viral infections. The trial includes different groups to compare the effects of DAS181 to a placebo (a harmless pill with no active drug). It may suit individuals who have undergone organ transplants, cancer treatments, or have other conditions that weaken the immune system and currently experience breathing issues requiring extra oxygen. As a Phase 3 trial, this is the final step before FDA approval, offering a chance to access potentially effective treatment early.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on any other investigational drug for pulmonary infection or certain immunomodulating biologics. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DAS181 has been tested for safety in several studies. For individuals with severe COVID-19, DAS181 has been administered under compassionate use, indicating it was provided to patients in urgent need. This suggests it is somewhat safe and might be beneficial. Other studies did not find a strong link between taking DAS181 and experiencing adverse side effects, indicating it was generally well-tolerated by patients.

Earlier trials did not identify a clear pattern of side effects directly caused by DAS181, suggesting it is relatively safe. Since this study is in Phase 3, it typically indicates the treatment has already demonstrated a good safety record in earlier stages. This is promising for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about DAS181 because it offers a unique approach to treating respiratory infections. Unlike typical antiviral medications, DAS181 works by inactivating a specific receptor on the surface of respiratory cells that viruses use to enter and infect cells. This novel mechanism stops the virus before it can even start replicating in the body. Additionally, DAS181's potential to treat COVID-19 and other respiratory infections with a single treatment adds significant versatility compared to standard treatments that often target specific viruses.

What evidence suggests that this trial's treatments could be effective for respiratory infections?

Research has shown that DAS181, which participants in this trial may receive, might help treat parainfluenza virus (PIV) infections. In one study, DAS181 helped patients recover from PIV and reduced the death rate linked to the virus. Another study found that DAS181 was effective even when treatment began later. For COVID-19, DAS181 has been tested and showed potential benefits for patients with severe cases. Overall, these findings suggest that DAS181 could be a promising treatment for these respiratory infections. ^{6 7 8 9 10}

Who Is on the Research Team?

Lisa Li

Principal Investigator

Ansun Biopharma, Inc.

Are You a Good Fit for This Trial?

This trial is for immunocompromised patients, including those who've had stem cell transplants or chemotherapy. It's open to adults and children with certain immune deficiencies and severe COVID-19 needing oxygen but not intensive ventilation. Participants must agree to contraception if applicable.

Inclusion Criteria

I am a man who has not had a vasectomy and will use birth control.

I have a weakened immune system due to a transplant, chemotherapy, a genetic condition, or a recent serious lung infection.

I understand and can follow the study's procedures.

Exclusion Criteria

I am currently taking a trial drug for lung infection.

Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug

You have certain abnormal liver function test results.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DAS181 or placebo for 7 or 10 days depending on cohort and weight

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary outcome measured by Day 28

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DAS181
• DAS181 COVID-19
• DAS181 OL
• Placebo

Trial Overview

The study tests DAS181, a drug for lower respiratory infections in the immunocompromised, against a placebo. A sub-study focuses on severe COVID-19 cases. The goal is to see if DAS181 can help these patients by comparing outcomes between the drug and placebo groups.

How Is the Trial Designed?

Group I: DAS181 COVID-19 Treatment Experimental Treatment 1 Intervention

DAS181 4.5mg q12h x 7 OR 10 days

Group II: Cohort 4 Experimental Treatment 1 Intervention

DAS181 4.5mg qd x 7 OR 10 days

Group III: Cohort 3 Experimental Treatment 1 Intervention

DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (\< 40kg)

Group IV: Cohort 1 and Cohort 2 Treatment Experimental Treatment 1 Intervention

DAS181 4.5mg qd x 7 OR 10 days

Group V: Cohort 1 and Cohort 2 Placebo Placebo Group 1 Intervention

Placebo qd x 7 OR 10 days

Group VI: DAS181 COVID-19 Placebo Placebo Group 1 Intervention

Placebo q12h x 7 OR 10 days

DAS181 is already approved in United States, European Union, China for the following indications:

Approved in United States as DAS181 for:

• Lower respiratory tract parainfluenza virus infections in immunocompromised patients
• Severe COVID-19

Approved in European Union as DAS181 for:

• Lower respiratory tract parainfluenza virus infections in immunocompromised patients
• Severe COVID-19

Approved in China as DAS181 for:

• Severe hospitalized influenza infections

Who Is Running the Clinical Trial?

Ansun Biopharma, Inc.

Lead Sponsor

Trials

11

Recruited

1,500+

Published Research Related to This Trial

In a study involving three male patients with severe COVID-19 pneumonia, nebulized DAS181 treatment for 10 days led to all patients returning to room air by day 14, indicating a significant improvement in respiratory function.

DAS181 was well tolerated with no reported adverse events, and it showed potential benefits in reducing the need for supplemental oxygen and improving clinical severity and inflammatory markers in hypoxic COVID-19 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resolution of Coronavirus Disease 2019 Infection and Pulmonary Pathology With Nebulized DAS181: A Pilot Study. Ho, JH., Zhao, Y., Liu, Z., et al.[2022]

In a study of 131 post-COVID-19 patients, about one-third continued to experience symptoms like cough and fatigue three months after discharge, indicating ongoing health issues related to COVID-19-related organizing pneumonia.

Despite persistent symptoms, most patients showed significant improvement in their lung imaging, with 94.8% of those who had follow-up CT scans demonstrating improvement, although those who had been in intensive care or on mechanical ventilation had poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of SARS-CoV-2 related organising pneumonia in COVID-19 survivors. Kho, SS., Lim, KC., Muhammad, NA., et al.[2023]

In a study involving 89 patients with mild COVID-19, favipiravir did not significantly improve viral clearance by day 6, but it was associated with a faster reduction in fever duration, suggesting potential benefits in symptom management.

The treatment was generally safe, with no disease progression or deaths reported during the 28-day study period, although 84.1% of patients experienced transient hyperuricemia as a side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19. Doi, Y., Hibino, M., Hase, R., et al.[2022]

In a post hoc analysis of 473 patients from the COVIDICUS trial, high-dose dexamethasone (DXM20) may provide a significant benefit for patients under 70 years old with acute respiratory failure if treatment is initiated within 7 days of symptom onset.

The analysis also indicated that patients receiving remdesivir had a higher probability of benefiting from high-dose dexamethasone, suggesting that certain patient characteristics can influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which severe COVID-19 patients could benefit from high dose dexamethasone? A Bayesian post-hoc reanalysis of the COVIDICUS randomized clinical trial. Chevret, S., Bouadma, L., Dupuis, C., et al.[2023]

A 10-month-old girl with respiratory distress due to COVID-19 was successfully treated with the investigational drug DAS181, which was well tolerated with minimal side effects.

The patient's respiratory distress and positive COVID-19 viral test quickly improved after starting DAS181 therapy, indicating its potential efficacy in treating severe respiratory symptoms associated with the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Treatment of Infant With COVID-19 With the Sialidase Fusion Protein, DAS181. Danziger-Isakov, L., Khalil, N., Divanovic, A., et al.[2023]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03808922

NCT03808922 | Phase III DAS181 Lower Tract PIV ...

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26904972/

DAS181 for Treatment of Parainfluenza Virus Infections in ...

Three patients (19%) died within 30 days and 2 of these deaths were related to PIV infection. Our data suggest that DAS181 may be an effective therapy for PIV ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04354389

Study Details | NCT04354389 | DAS181 for STOP COVID-19

It is a multicenter, randomized, placebo-controlled, double-blind study. The study population is defined as subjects diagnosed with lower respiratory tract ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4091581/

An Investigational Antiviral Drug, DAS181, Effectively ...

Importantly, our data demonstrate that delayed treatment with DAS181, initiated 24–72 hours after wild-type virus infection, resulted in 75%–100% protection in ...

5.

synapse.patsnap.com

synapse.patsnap.com/drug/6be8246b7b12478289121098a75e7f93

oplunofusp - Drug Targets, Indications, Patents

Results: A total of 111 patients were randomized to DAS181 (n = 74) or placebo (n = 37). CSS was achieved by 45.0% DAS181-treated patients in the SO stratum ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01113034

A Safety Trial of DAS181 (Fludase®) in Adult Subjects With ...

DAS181 is not being given to treat asthma or bronchiectasis, but to learn if it is safe to use in people with well-controlled asthma or bronchiectasis. DAS181 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04324489

DAS181 for Severe COVID-19: Compassionate Use

The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19. Detailed Description. Each ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4639451/

Phase 1 Clinical Trials of DAS181, an Inhaled Sialidase, in ...

DAS181, (study drug, Fludase®) was developed for treatment of influenza and parainfluenza infections ... safety data from each cohort. Safety laboratory ...

9.

clinpgx.org

clinpgx.org/literature/15107482

Clinical Trial: DAS181 for STOP COVID-19

Subjects with COVID-19 and clinically significant impairment of respiratory function will be enrolled and evaluated. If pre-determined safety and efficacy ...

10.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4736611/

A phase 1 randomized, double-blind, placebo-controlled ...

A statistically significant association between exposure to DAS181 and experiencing any AE, a grade 1 AE, or a grade 2 AE was not detected.