Fosmanogepix for Mold Infections

Recruiting at 8 trial locations

Overseen By Marc Engelhardt, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Basilea Pharmaceutica

Must be taking: Antifungals

Disqualifiers: Refractory hematologic malignancy, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 12 weeks (84 days), extendable up to 180 days

219 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a new treatment called fosmanogepix, an antifungal medication, for individuals with difficult mold infections. Participants will receive either fosmanogepix or the usual antifungal treatment in the first group, or only fosmanogepix in the second group, which includes those unresponsive to other treatments. The trial seeks individuals with specific mold infections who can manage the necessary infection control procedures. The primary goal is to determine if fosmanogepix can improve survival rates by 42 days after treatment begins. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants access to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that certain medications might be prohibited. It's best to discuss your current medications with the trial team to see if any are not allowed.

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

Research has shown that fosmanogepix is generally safe and well-tolerated. It effectively treats certain fungal infections, such as candidemia, a bloodstream infection caused by Candida fungi. One study found that patients with severe mold infections had a 25% death rate, which aligns with expectations for such serious conditions. This suggests that the treatment is relatively safe given the severity of these infections.

Fosmanogepix represents a new class of drugs, working differently from existing antifungal medications. Previous tests on patients demonstrated that it can be safely administered both through an IV drip and as a pill. While no treatment is without risks, current data on fosmanogepix indicates that it is usually well-tolerated, with most people not experiencing severe side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for mold infections?

Fosmanogepix is unique because it offers a novel approach to tackling mold infections. Unlike traditional antifungal treatments like amphotericin B and voriconazole, which can have significant side effects and resistance issues, Fosmanogepix targets the fungal cell wall with a new mechanism of action. This innovative approach not only broadens the treatment options but also holds promise for effectiveness against resistant strains, making it a game-changer in the fight against stubborn fungal infections. Researchers are excited about its dual delivery method—either as an IV infusion or an oral tablet—offering flexibility and convenience for patients.

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

Research has shown that fosmanogepix, which participants in this trial may receive, may effectively treat serious mold infections. In one study, patients who received fosmanogepix had a 25% death rate from all causes, lower than the rates usually seen with other treatments. Earlier trials also found that fosmanogepix worked better than amphotericin B, a common antifungal medication. This suggests that fosmanogepix could be a more effective choice for patients with these serious infections. The treatment attacks the cell walls of fungi, making it harder for the mold to survive and spread. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel Ionescu, MD

Principal Investigator

Basilea Pharmaceutica International Ltd, Allschwil

Are You a Good Fit for This Trial?

Adults with invasive mold infections, such as those caused by Aspergillus or other resistant molds, can join this trial. It's for patients who haven't responded to standard treatments or have conditions like refractory hematologic malignancy and chronic aspergillosis. People with multiple fungal pathogens, severe kidney issues requiring dialysis, HIV infection, ongoing neurological disorders, or very poor health status cannot participate.

Inclusion Criteria

I have a fungal infection confirmed by tests.

My condition allows for treatments to control infections.

Exclusion Criteria

My blood cancer does not respond to treatment.

Pregnancy or lactation

Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive fosmanogepix or standard antifungal treatment for invasive mold infections

12 weeks (84 days), extendable up to 180 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fosmanogepix

Trial Overview The study tests Fosmanogepix (IV infusion or oral tablet) against the usual antifungal treatments in two groups: one receiving it as primary therapy and another as salvage treatment after previous failures. The main goal is to see if there are fewer deaths by Day 42 compared to a set threshold.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 2 Interventions

Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.

Group II: Cohort A: Experimental Treatment Experimental Treatment 2 Interventions

Patients will receive the study drug. Fosmanogepix will be administered as an Intravenous (IV) infusion or in oral form.

Group III: Cohort A: Comparator Antifungal Treatment Active Control 1 Intervention

Best available therapy (BAT) administered as IV or orally per standard guidelines.

Who Is Running the Clinical Trial?

Basilea Pharmaceutica

Lead Sponsor

Trials

53

Recruited

9,900+

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Citations

1. academic.oup.com academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaf185/8109478

Fosmanogepix for the Treatment of Invasive Mold Diseases ... Fosmanogepix 1000 mg intravenous (IV) (loading dose) and 600 mg IV or 800 mg oral (maintenance dose) resulted in 25% all-cause mortality at ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06925321

NCT06925321 | A Phase 3 Efficacy and Safety Study of ... The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive ...

3. basilea.com basilea.com/news/news?tx_news_pi1%5Baction%5D=detail&tx_news_pi1%5Bcontroller%5D=News&tx_news_pi1%5Bnews%5D=1559&type=1546938654&cHash=45190dd3388badc21454ffc69ac5d0f4

Basilea initiates phase 3 study with antifungal ... Study to evaluate the efficacy and safety of fosmanogepix in adults with invasive mold infections; Study completion expected in Q1 2028.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11131969/

Fosmanogepix: The Novel Anti-Fungal Agent's ... Mortality rates from invasive fungal infections vary, with a range of 70% for candidiasis, 50-75% for aspergillosis, and 30-90% for infections ...

5. jwatch.org jwatch.org/na58740/2025/05/06/fosmanogepix-continues-show-potential-against-invasive

Fosmanogepix Continues to Show Potential Against ... In a phase 2 trial, this novel antifungal agent yielded better outcomes than historically seen with amphotericin B.

6. journals.asm.org journals.asm.org/doi/10.1128/aac.01623-22

Safety and Pharmacokinetics of Intravenous and Oral ... Fosmanogepix: a review of the first-in-class broad spectrum agent for the treatment of invasive fungal infections. J Fungi (Basel) 6:239. View.

7. pfizer.com pfizer.com/sites/default/files/plsr-studies/APX001-202%20(C4791010)%20Plain%20Language%20Study%20Results%20Summary%20(PLSRS)%20Phase%202.pdf

– Thank You – IMI is often severe and can lead to death in about 30% to 80% of people with these infections. What is fosmanogepix? Fosmanogepix is the study ...