ARN-75039 for Lassa Fever
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new antiviral pill, ARN-75039, for treating Lassa fever, a serious viral illness, in hospitalized patients. The researchers aim to assess the safety and effectiveness of this new treatment compared to the usual intravenous drug, ribavirin. Participants will be divided into three groups to receive either a high dose or low dose of ARN-75039 or ribavirin, with the study tracking their recovery and any side effects. The trial seeks adults who have tested positive for Lassa fever and require hospital care. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial requires that you have not received specific drug therapy for Lassa fever, like ribavirin or other antivirals, within 15 days before joining. It doesn't specify about other medications, so it's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Earlier studies have shown that ARN-75039 is safe and well-tolerated in people. Research suggests that this antiviral drug effectively protects against the Lassa virus in animal tests, including those with guinea pigs. Additionally, previous studies with healthy participants found that ARN-75039 was well-tolerated at various doses, with no serious side effects reported. This evidence supports the safety of ARN-75039 as it undergoes testing in current clinical trials for treating Lassa fever.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for Lassa Fever, which typically involves intravenous Ribavirin, ARN-75039 is an oral antiviral agent. Researchers are excited because ARN-75039 offers a potentially more convenient oral administration, which could be easier for patients to manage compared to intravenous treatments. Additionally, ARN-75039 targets the virus in a new way, which might lead to improved outcomes or reduced side effects. The high and low dose regimens allow for flexibility in treatment based on patient needs, which could further enhance its effectiveness and safety profile.
What evidence suggests that this trial's treatments could be effective for Lassa fever?
Research has shown that ARN-75039, a new oral antiviral drug, could effectively treat Lassa fever. In animal studies, those given ARN-75039 exhibited few signs of illness and had no detectable virus in their blood, suggesting the drug may help reduce the virus in the body. ARN-75039 targets a part of the virus crucial for entering cells and causing infection. Early studies have demonstrated that the drug is both effective against the virus and safe to use. These results support further testing of ARN-75039 as a potential treatment for Lassa fever. Participants in this trial will receive either a high or low oral dose of ARN-75039 or the standard of care, Ribavirin intravenous (IV).12678
Who Is on the Research Team?
Ken McCormack, PhD
Principal Investigator
Arisan Therapeutics, Inc.
Are You a Good Fit for This Trial?
This trial is for adults (18+) in West Africa who are hospitalized with confirmed Lassa fever. Participants must be able to give consent and cannot join if they are pregnant, have severe liver, heart, or digestive diseases, chronic itching, recent Lassa treatment or vaccine.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either ARN-75039 or ribavirin for 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- ARN-75039
Trial Overview
The study compares two oral doses of a new antiviral drug called ARN-75039 with standard intravenous ribavirin in people hospitalized for Lassa fever. Participants are randomly assigned to one of the three treatments for 10 days.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
ARN-75039 is an investigational oral antiviral agent administered as tablets. This high dose regimen includes a 150 mg initial dose and 100 second dose on day 1, followed by a 100 mg BID dose on day 2 and 50 mg BID days 3-10.
ARN-75039 is an investigational oral antiviral agent administered as tablets. This high dose regimen includes a 300 mg initial dose and 200 second dose on day 1, followed by a 200 mg BID dose on day 2 and 100 mg BID days 3-10.
Standard of Care "Irrua regimen"
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arisan Therapeutics, Inc.
Lead Sponsor
Federal Medical Centre, Owo
Industry Sponsor
Battelle Memorial Institute
Collaborator
JPEO, Chemical, Biological, Radiological, and Nuclear, Medical
Collaborator
Alliance for International Medical Action
Collaborator
Irrua Specialist Teaching Hospital
Collaborator
Bernhard Nocht Institute for Tropical Medicine
Collaborator
ANRS, Emerging Infectious Diseases
Collaborator
Citations
The virus entry inhibitor ARN-75039 provides therapeutic ...
ARN-75039–treated animals exhibited minimal disease signs and undetectable viremia. These results suggest that ARN-75039, for which a phase 1 ...
ARN-75039 Lassa Fever Treatment in West Africa
ARN-75039 is a small-molecule viral entry inhibitor targeting the Lassa virus glycoprotein complex and has demonstrated potent antiviral activity and favorable ...
Initiation of ARN-75039 API and Drug Product NDA ...
AVHF resulting from infection with the Old World arenavirus Lassa is estimated to cause over 300,000 annual infections in Western Africa, of which 15-20% of ...
Potent inhibition of arenavirus infection by a novel fusion ...
Taken together, the data strongly support the continued development of ARN-75039 as a candidate therapeutic for the treatment of severe arenaviral diseases.
The virus entry inhibitor ARN-75039 provides therapeutic ...
ARN-75039-treated animals exhibited minimal disease signs and undetectable viremia. These results suggest that ARN-75039, for which a phase 1 ...
pH-induced conformational changes and inhibition of the ...
The virus entry inhibitor ARN-75039 provides therapeutic protection against Lassa virus infection in guinea pigs. 2026, Science Translational ...
Potent inhibition of arenavirus infection by a novel fusion ...
Here, we report on the antiviral activity and pre-clinical development of the novel broad-spectrum arenavirus fusion inhibitors, ARN-75039 and ARN-75041.
ARN-75039 Lassa Fever Treatment in West Africa
This multicenter, randomized, open-label Phase 2 clinical trial evaluates the safety, tolerability, and virologic efficacy of ARN-75039, ...
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