Olorofim for Valley Fever

JE
Overseen ByJose Elizondo
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 olorofim, a new medication for treating Coccidioidal (Cocci) meningitis, a serious fungal infection affecting the brain and spinal cord. The goal is to determine olorofim's effectiveness in treating this condition in its early stages. People diagnosed with Cocci meningitis in the last 4 to 8 weeks who do not have a brain pressure-relief device might be suitable candidates. Researchers will follow participants for about 6 months to monitor their health and response to treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but some medications are prohibited, like teriflunomide, leflunomide, and cannabis products. It's important to discuss potential drug interactions with the study team before enrolling.

Is there any evidence suggesting that olorofim is likely to be safe for humans?

Research has shown that olorofim is generally well tolerated by people with various fungal infections. Patients have used it safely for many days, typically for about 12 weeks, indicating that they usually handle the treatment well with few side effects.

In studies on difficult-to-treat fungal diseases, olorofim demonstrated positive results, even when other treatments failed. The FDA has given it special recognition for its potential to treat rare infections, highlighting its promising safety profile.

Overall, early data suggests that olorofim is generally safe for humans, but further research is needed to fully understand any potential risks.12345

Why do researchers think this study treatment might be promising?

Olorofim is unique because it targets a specific enzyme in fungal cells called dihydroorotate dehydrogenase, which is crucial for their growth and survival. Unlike the standard treatments for Valley Fever, such as fluconazole or itraconazole, which often take longer to show effectiveness, olorofim has a novel mechanism that may lead to faster symptom relief. Researchers are excited about its potential to offer a more effective and targeted approach, especially for patients who don’t respond well to existing antifungal medications.

What evidence suggests that olorofim might be an effective treatment for Valley Fever?

Research has shown that olorofim has potential in treating fungal infections, including those caused by the fungus Coccidioides, which leads to Valley Fever. In lab tests, olorofim stopped this fungus from growing, even in very small amounts. Among patients with serious fungal infections, nearly 60% responded well to olorofim within six weeks. This trial will evaluate the effectiveness of olorofim in treating coccidioidal meningitis, but further research is needed to confirm its effectiveness.26789

Who Is on the Research Team?

FD

Fariba Donovan, MD, PhD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for individuals recently diagnosed with Coccidioidal meningitis, a brain and spinal cord infection caused by a fungus. Participants must have been diagnosed within the last 8 weeks, be able to give consent, and not have a VP shunt. Women of childbearing potential must use effective birth control during the study.

Inclusion Criteria

I have undergone a procedure for male sterilization.
a) who have given voluntary written informed consent, or whose legally authorized representative(s) has been fully informed and has given voluntary written informed consent if applicable, and in compliance with local regulations OR 2. b) who have given oral informed consent witnessed in writing by an independent person and in compliance with local regulations for patients who are unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative).
I was diagnosed with fungal meningitis less than 8 weeks ago.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive treatment with olorofim for coccidioidal meningitis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension (optional)

Participants may opt into the olorofim Managed Access Program to continue treatment after completion of the study period

What Are the Treatments Tested in This Trial?

Interventions

  • Olorofim

Trial Overview

The trial is testing olorofim's effectiveness in treating early-stage Coccidioidal meningitis. About 10-12 participants will be monitored over six months to see how well they respond to the treatment. There's also an option to continue receiving olorofim after the study ends.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: olorofimExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fariba Donovan

Lead Sponsor

F2G Biotech GmbH

Industry Sponsor

Trials
21
Recruited
1,800+

Citations

Olorofim demonstrates in vitro activity against Coccidioides ...

Olorofim demonstrated potent in vitro activity against all isolates tested with a minimum inhibitory concentration (MIC) range ≤0.008–0.06 μg/mL.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40541222/

Olorofim for the treatment of invasive fungal diseases in ...

Olorofim showed efficacy and good tolerability in patients with IFD with few or no treatment options. Further studies will be needed to fully delineate the ...

Olorofim for the treatment of invasive fungal diseases in ...

A successful clinical response was seen in 121 patients (59·9%, 52·8–66·7) at day 42 and in 109 patients (54·0%, 46·8–61·0) at day 84. All-cause ...

TREATMENTS FOR COCCIDIOIDOMYCOSIS (Cocci)

HOW WELL IT WORKS: Achieved satisfactory response in 86% of patients with skeletal coccidioidomycosis, 55% of those with chronic pulmonary disease, and 76% of ...

Antifungal Drugs for Coccidioidomycosis

"Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses study group and European.

F2G's olorofim receives both FDA Orphan Drug ...

Olorofim has been well tolerated across more than 21 years of patient dosing days with a median therapy duration of 12 weeks. Preliminary ...

Coccidioidomycosis (Valley Fever)

Examined olorofim treatment in mouse. Coccidioidomycosis infection models. Significant protection was seen in the CNS infection model. Tell us ...

F2G Announces Data from Phase 2b Study

Olorofim has received orphan drug status from the European Medicines Agency for the treatment of invasive aspergillosis and invasive ...

95. Novel Antifungal Olorofim Use in Intractable CNS and Non ...

Olorofim has a positive benefit-risk profile in DCM patients with no or limited treatment options. Favorable Clinical Responses were seen in ...