A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.

Launched by BASILEA PHARMACEUTICA · Jun 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Fosmanogepix to see how safe and effective it is for treating serious fungal infections known as candidemia and invasive candidiasis. These infections are caused by a type of yeast called Candida and can be life-threatening. The trial is looking for adult participants who have been diagnosed with these infections. To be eligible, participants need to be at least 18 years old and have a confirmed diagnosis of candidemia or invasive candidiasis within the last four days.

Participants in the study will be divided into two groups. About two-thirds will receive Fosmanogepix through an intravenous (IV) infusion, followed by oral tablets, while the other third will receive a standard treatment regimen. The treatment will last up to six weeks, and the doctors will monitor how well it's working. Participants will visit the clinic regularly during treatment and have a follow-up appointment six weeks after finishing the study medication. This trial aims to determine if Fosmanogepix is just as effective as the standard treatment, ensuring that patients have access to safe and effective options for these serious infections.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients ≥ 18 years (or the minimum country-specific age of consent if \> 18) at Screening who have provided signed informed consent indicating that they understand the purpose of, and procedures required for, the study, and are willing to participate in the study. If the patient is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
• • 2. Diagnosis of candidemia and/or invasive candidiasis based on a blood or non-blood specimen obtained within ≤ 96 hours (4 days) before randomization, and on clinical criteria judged attributable to candidemia/invasive candidiasis occurring at any time from ≤ 12 hours prior to the qualifying positive index culture being taken through to randomization.
• • 3. Patient's condition allows for appropriate infection source control measures, including removal of pre-existing intravascular catheters and devices, if necessary.
• Exclusion Criteria:
• • 1. Existing infection
• • 1. Infection known to be due to Candida krusei, in blood or any other normally sterile site.
• • 2. Inappropriate fungal infection source control.
• • 3. Diagnosis of certain deep-seated Candida infections.
• • 2. Life expectancy of \< 72 hours in the opinion of the investigator.
• • 3. Requirement, or expected requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
• • 4. Ongoing neurological disorders, including specified conditions presenting with a CTCAE Grade ≥ 2 (neurological symptoms that are considered to be a consequence of the current episode of candidemia / invasive candidiasis are not exclusionary).
• • 5. Patients with known human immunodeficiency virus infection, who have CD4+ count \< 200/mm3 or viral load \> 400 copies/mL), or who have had an active opportunistic infection within 6 months prior to Screening.
• • 6. Other medical or psychiatric condition or laboratory abnormality that may increase the risk of study participation or make the patient inappropriate for the study.
• • 7. Current use of any prohibited concomitant medications or those unwilling/unable to use a permitted concomitant medication.
• • 8. Received \> 2 days (\> 48 hours) equivalent of prior systemic antifungal treatment at approved doses and frequency to treat the current episode of candidemia and/or invasive candidiasis (e.g., \> 2 doses of a once daily antifungal agent or \> 4 doses of a twice daily antifungal agent), within the 96 hours prior to randomization (except for non-susceptible Candida spp. and for patients who develop candidemia or invasive candidiasis while on prophylaxis with an azole or amphotericin B).
• • 9. Previous administration with an investigational drug or investigational vaccine within 30 days or 5 half-lives preceding the first dose of study drug used in this study (whichever is longer).
• • 10. Prior participation in this or any previous study of fosmanogepix.
• • 11. Moderate or severe hepatic impairment, known active viral hepatitis B or C, ALT or AST ≥ 5 × ULN or total bilirubin \> 3 × ULN unless this is due to isolated hyperbilirubinemia or documented Gilbert's syndrome.
• • 12. Female patient is pregnant or lactating.
• • 13. Known hypersensitivity to fosmanogepix, manogepix, caspofungin, any echinocandin, fluconazole or to any of their excipients.
• • 14. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and Sponsor and Sponsor delegate employees directly involved in the conduct of the study and their family members.