ARN-75039 for Lassa Fever

Not currently recruiting at 3 trial locations
DW
GM
Overseen ByGia Malka Clinical Operations / FHI Clinical, Durham NC USA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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?

KM

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

Positive plasma Lassa virus RT-PCR at screening
Able to provide written informed consent, or consent provided by a legally authorized representative
Requires hospitalization for Lassa fever per local clinical guidelines
See 2 more

Exclusion Criteria

Pregnant (confirmed by positive urine pregnancy test in women of childbearing potential)
I have a history of long-lasting, widespread itching.
I have had a serious digestive or intestinal disease.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ARN-75039 or ribavirin for 10 days

10 days
Daily inpatient visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 days
Regular follow-up assessments

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

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

Group I: ARN-75039: 50 mg maintenance (low oral dose)Experimental Treatment1 Intervention
Group II: ARN-75039: 100 mg maintenance (high oral dose)Experimental Treatment1 Intervention
Group III: Ribavirin intravenous (IV)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arisan Therapeutics, Inc.

Lead Sponsor

Trials
1
Recruited
60+

Federal Medical Centre, Owo

Industry Sponsor

Trials
6
Recruited
5,400+

Battelle Memorial Institute

Collaborator

Trials
14
Recruited
1,800+

JPEO, Chemical, Biological, Radiological, and Nuclear, Medical

Collaborator

Alliance for International Medical Action

Collaborator

Trials
23
Recruited
85,100+

Irrua Specialist Teaching Hospital

Collaborator

Trials
3
Recruited
3,000+

Bernhard Nocht Institute for Tropical Medicine

Collaborator

Trials
20
Recruited
19,000+

ANRS, Emerging Infectious Diseases

Collaborator

Trials
222
Recruited
15,380,000+

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.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41984932/

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, ...