Cutaneous leishmaniasis
Target product profile for cutaneous leishmaniasis
Cutaneous leishmaniasis
Target product profile for cutaneous leishmaniasis
DNDi aims to develop a topical or oral treatment for all species of leishmania causing cutaneous or mucocutaneous leishmaniasis that is safe and effective for all patients and does not require a cold chain.
Target product profile for cutaneous leishmaniasis
| Ideal | Acceptable | |
|---|---|---|
| Target species | One treatment for all species of Leishmania | L. tropica or L. braziliensis |
| Safety/tolerability | Well tolerated All adverse reactions (AR)s ≤ grade 1 | Safety monitoring at primary health care (PHC) level. No major safety concerns: Well tolerated in >95% of patients treated. Systemic AR ≤ Grade 3 in <5%. Local AR ≤ grade 2 in <30% No treatment-induced mortality |
| Contraindications | None | Can be assessed at primary health care level. |
| Efficacy | >95% patients with complete clinical cure, defined as 100% epithelialization/flattening of lesion(s) at 3 months from treatment onset Minimal scar No relapse or development of Leishmania recidivans or mucocutaneous leishmaniasis (MCL) Parasitological endpoint not required | 60% epithelialization/flattening of lesion(s) for L. tropica and 70% for L. braziliensis patients with complete cure Scar no worse than natural healing <5% rate of relapse or development of Leishmania recidivans or MCL at 1 year |
| Formulation | Topical / oral | Non-parenteral, or few doses if parenteral |
| Treatment regimen | Topical ≤ 14 days Oral < 7 days | Topical: 28 days Oral: twice daily for 28 days Parenteral ≤ 3 injections |
| Target population | No restrictions | >9 months of age No efficacy in immune-compromised patients Not for use in pregnancy (category B*) |
| Stability | No cold chain At least 3 years at 37º C | 2 years at 4-8º C |
| Cost | To be defined | To be defined |
* No signs of risk in animal studies, but no adequate studies in humans
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