US pharmaceutical company Mycovia Pharmaceuticals Inc announced on Wednesday that the first participant has been enrolled in an investigator-initiated clinical trial evaluating oteseconazole and other investigational products for cryptococcal meningitis.

The Phase 2 PLATFORM-CM study marks a significant research effort aimed at improving treatment options for cryptococcal meningitis, Mycovia said.

Dr. David Boulware, professor of Medicine, Infectious Disease and International Medicine at the University of Minnesota, School of Public Health, and Dr. David Meya, associate professor at the School of Medicine at the College of Health Sciences, Makerere University in Uganda, designed the study and will serve as principal investigators. PLATFORM-CM is an open-label randomised trial with single or potentially multiple interventional arms to compare the efficacy and safety of antifungal investigational therapies, including oteseconazole, to the standard of care WHO first-line therapy in treating cryptococcal meningitis. The clinical trial will be conducted at three sites in Uganda and will involve up to 200 participants who will be treated for 18 weeks with oteseconazole.

Oteseconazole is designed to selectively inhibit fungal CYP51, which is required for fungal cell wall integrity, and this interaction is also toxic to fungi, resulting in the inhibition of fungal growth. Preclinical studies have demonstrated that oteseconazole is potent against fluconazole-sensitive and -resistant strains of Cryptococcus.

"Mycovia is committed to making a meaningful impact in our global community and driving innovation for unmet or underserved medical needs through clinical research and collaboration," commented Dr. Stephen Brand, Mycovia chief development officer. "This study will serve to further evaluate oteseconazole beyond its currently approved indication and expand upon the encouraging preclinical data that suggests oteseconazole may have clinical utility in treating this serious fungal infection of the brain and central nervous system."