DNDi aims to develop a less than six-month oral, daily treatment for eumycetoma for all patients in all regions, with high efficacy and no need to monitor for safety.
Target product profile for eumycetoma (fungal mycetoma)
Ideal | Acceptable | |
---|---|---|
Target population | Adults and children aged ≥5 Immunocompetent or immunocompromised Pregnant and lactating | Adults Immunocompetent |
Geographic distribution | All regions including India | West and East Africa |
Treatment regimen | Once daily <6 months without surgery | Twice daily 6 months with surgery 6-12 months without surgery |
Formulation | Oral | Oral or intramuscular injection |
Monitoring and efficacy | Clinical 6 weeks | Clinical 6 weeks |
Efficacy | Cure rate of >90% No need for surgery (as in actinomycetoma) | Cure defined as: complete disappearance of mass, closure of sinuses. Skin returned to normal. Acceptable ≥ketoconazole and cure ≥75% |
Tolerability/safety | No need for monitoring | Liver function monitoring (every 6 weeks) – no more discontinuation due to liver enzyme increase than with ketoconazole (est. 5%) |
Drug-drug interactions | None | Adequate with ACTs or forgiveness and usual antibiotic treatments – contraception |
Contraindications | None | Pregnant & lactating women |
Cost | Not more than for actinomycetoma or Buruli treatment – acceptable for Essential Medicines List | USD 200 (based on actinomycetoma cost in Sudan) |