Mycovia Starts Phase 2 Study for Cryptococcal Meningitis Enrollment

Mycovia Starts Phase 2 Study for Cryptococcal Meningitis Enrollment

By, Admin 5 June 2025

Mycovia Pharmaceuticals, Inc. has announced the enrollment of the first participant in an investigator-initiated Phase 2 clinical trial evaluating oteseconazole and other investigational products for cryptococcal meningitis.

This is an investigational use that has not yet been approved by the U.S. Food and Drug Administration (FDA). Known as the PLATFORM-CM study, the trial represents a significant step in expanding treatment options for this life-threatening fungal infection.

Study Overview and Research Leadership

PLATFORM-CM is designed as an open-label, randomized clinical trial that may include one or more interventional arms. It will evaluate investigational antifungal therapies, including oteseconazole, against the WHO’s current first-line therapy.

Study highlights:

  • Type: Open-label, randomized trial
  • Interventions: Oteseconazole and other investigational therapies
  • Comparator: WHO standard-of-care treatment
  • Location: 3 clinical sites in Uganda
  • Sample size: Up to 200 participants
  • Duration: 18 weeks of treatment

Principal Investigators:

  • Dr. David Boulware, University of Minnesota, USA
  • Dr. David Meya, Makerere University, Uganda

Addressing Urgent Medical Needs

Cryptococcal meningitis remains a major health burden, especially in regions with high rates of HIV.

Why this trial matters:

  • High mortality: Estimated 112,000 deaths and 152,000 cases annually, primarily in Africa
  • At-risk population: Leading cause of death among people living with HIV
  • Current therapy challenges:
    • Limited access and distribution
    • Drug toxicity concerns
    • Resistance issues and supply constraints

“Our goal is to generate meaningful data that will show a reduction in death for patients that cannot use or who have developed resistance to current standard of care treatments.”

  • Dr. David Boulware, University of Minnesota, USA

Oteseconazole’s Potential in Cryptococcal Meningitis

Oteseconazole is a novel antifungal agent designed to target fungal CYP51, a key enzyme necessary for maintaining fungal cell wall integrity.

Key features of oteseconazole:

  • Mechanism of action: Inhibits fungal CYP51 enzyme, disrupting cell wall synthesis
  • Preclinical efficacy:
    • Active against fluconazole-sensitive and -resistant strains of Cryptococcus
    • Demonstrated potential to overcome drug resistance
  • Favorable pharmacological profile:
    • Long half-life
    • Lower toxicity
    • Fewer drug-drug interactions

“This study will serve to further evaluate oteseconazole beyond its currently approved indication and expand upon the encouraging preclinical data.”

  • Dr. Stephen Brand, Chief Development Officer, Mycovia

About Mycovia Pharmaceuticals, Inc.

Mycovia is a biopharmaceutical company focused on developing novel therapies for underserved medical needs, particularly in the antifungal space.

Company highlights:

  • Lead product: VIVJOA® (oteseconazole)
    • First and only FDA-approved therapy to reduce recurrent vulvovaginal candidiasis (RVVC)
    • Approved for females not of reproductive potential
    • Granted Fast Track and Qualified Infectious Disease Product designations by FDA
  • Global reach: Licensed to Jiangsu Hengrui Pharmaceuticals for commercialization in Greater China
  • Research focus: Oral antifungals targeting multi-drug-resistant fungal pathogens

Mission: To address urgent global health challenges through science, innovation, and partnerships.

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